TECO DIAGNOSTICS

MAR 2 7200b

Voo /ZO

1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 693-7788 Toll Free: 1-800-222-9880 ~~~~~Fax: (714) 693-3838 www.tecodia2.com Email:tecodiag~tecodiag.com
Updated 510OK summary Teco CX3 Reagent Set for SYNCHRON CX Contact Name: Jian Vaeches Phone Number: 714-693-7788 ext. 131 Prepared Date: 03/20/2006
1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 693-7788 Toll Free: 1-800-222-9880

Fax: (714) 693-3838

www.tecodiag.com Email:tecodiaggtecodiag.com
Device Name The device trade names and common/classifications name are:
Device Trade Name Teco CX3 Reagent Set for SYNCHRON CX System Common/Classification Name BUN, CALCIIM, REATININEGLUCOSE REGENTS

Address and Registration

The address and registration number of the manufacturer site for Teco CX3 Reagent Set for SYNCHRON CX System: TECO Diagnostics 1268 N. Lakeview Ave. Anaheim, CA 92807, U.S.A. FDA Registration # 1832216

Device Classs

Teco CX3 Reagent Set has been classified as Class II with Product Code ~lo, JFt CGX, CGA "in vitro" diagnostics reagent set having the classification number: 21 CFR. 862.1770, 21 CFR 862.1145, 21 CFR 862.1225, 21 CFR 862.1345. This is the description available from the classification names listed in the "CDRH Home Page- Listing Database."

Cta CQ

Predicate Device Information
The predicate device is Teco BUN Liquid, Teco Calcium Color, Teco Creatinine and Teco Glucose Liquid Reagent. The 510 (K) approval letter is provided in Appendix I. 510(K) #: K981106, K864741, K880629, K863926. Approval Date: 04-16-1998, 01-09-1987, 03-23-1988, 11-13-1986
www.tecodiag.com Email:tecodiag~tecodiag.com
Labeling and Intended Use
Draft labels and Instructions for use can be found in appendix A.

Intended Use

Teco CX3 Reagent Set for SYNCHRON CX is intended for the quantitative determination of BUN, Calcium, Creatinine and Glucose in serum on Beckman CX3 System.
Device Description and Comparison
The Teco CX3 Reagent Set for SYSNCHRON CX designed for use on the Beckman CX System. The Reagent Set includes BUN, Calcium, Creatinine and Glucose. Method Comparison of Teco CX3 Reagent Set for SYNCHRON CX to Teco BUN Liquid, Teco Calcium Color, Teco Creatinine and Teco Glucose Liquid following the guidelines of NCCLS Guideline EP9-A2 was conducted. Comparison with predicate: Similarities Intended use. Sample Handling Subsystem. Operational Environment Performance.
Differences Predicate Device Packaging Size BUN
Calicium Creatinine Glucose Analyzer Components BUN Tris Buffer 100 mmol 2-Oxoglutarate 5 mmol Urease >20,000 U/L GLDH > 1500 U/L NADH 0.25 mmol/L Predicate Device Candidate Device Urease >592 U/mi

Candidate Device

5 x 25 ml & 5 x 5 ml
4 x 120 ml 4 x 120 ml 4 x 120 ml General Chemistry Analyzers
500 ml 2000 ml 500 ml SYSCHRON CX3
www.tecodian.com Email:tecodiag

tecodiag.com

Calcium
O-Cresolphthalein Complexone 0.14 mM 8-Hydroxyquinoline 13 mM Diethylamide 363 mM

Arsenazo III 0.15 mml/L

Creatinine
Picric Acid 10mM Sodium Hydroxide 240mM
Picric Acid 50mM Sodium Hydroxide 0.188 mM Glucose Oxidase 590 u/mI Ethanol 10% Potassium Iodide 0.04 mM

Glucose

Glucose Oxidase 15 u/ml Peroxidase 1.2 u/ml 4-Aminoantipyrine 0.38 mM p-Hydroxybenzene Sulfonate 10 mM
1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 693-7788 Toll Free: 1-800-222-9880 Fax: (714) 693-3838 www.tecodiag.com Email:tecodiag tecodiag.com
Standard/ Guidance Document Referenced (if applicable)
NCCLS EP5-A--Evaluation of Precision Performance of Clinical Chemistry Devices NCCLS EP6-A--- Evaluation of Linearity of Quantitative Analytical Methods NCCLS EP9-A---Method Comparison and Bias Estimation Using Patient Samples

Test Principle

BUN (Urea Nitrogen) is hydrolyzed by urease to produce ammonium and bicarbonate which resulted in the increase of solution conductivity which is directly proportional to the concentration of BUN present in the test, Calcium reacts with Arsenazo to form an bluish-purple colored chromophore which is measured spectrophotometrically at 650 nm. A reagent blank reading is taken just prior to sample injection, and a final absorbance reading is taken 21 seconds later. The differential absorbance, corrected for the reagent blank, is directly proportional to the calcium concentration. Creatinine from the sample combines with the reagent to produce a red color complex. Absorbance reading is taken at both 520nm and 560nm at 25.6 seconds after picking up sample. The differential absorbance has been shown to be a direct measure of the concentration of creatinine in the sample. SYSNCHRON CX3 determines glucose concentration by an oxygen rate method using a glucose Oxygen electrode. The rate of oxygen depletion is proportional to the glucose concentration in the samples.
1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 693-7788 Toll Free: 1-800-222-9880 Fax: (714) 693-3838 www.tecodiag.com Email:tecodiaggtecodiag.com

Substantial Equivalence

The Teco CX3 Reagent Set for SYNCHRON CX System is substantially equivalent to other devices legally marketed in the United States. We have compared TECO Diagnostics Teco CX3 Reagent Set for SYNCHRON CX System to TECO Diagnostics Teco BUN Liquid, Teco Calcium Color, Teco Creatinine and Teco Glucose Liquid Reagent for Hitachi.The 510 (K) numbers are K981106, K864741, K880629, and K863926. Both devices are for the quantitative determination of the same analyst in serum.
Summary of Design Control Activities
The risk analysis method used to assess the impact of modifications was a Failure Modes and Effects Analysis (FMEA). The design verification tests that were performed as a result of this risk analysis assessment are listed in table l&2 below. The tests data can also be found in appendix C through F.

1. Table 1 - Performance Characteristics (Human Serum) BUN:
Feature Precision Within-Day Predicate Device Sample 1 N=20 Mean=12.9 SD=0.33 CV%=2.62 Sample I N=20 Mean=12.4 SD=0.15 CV%=1.2 Sample 2 N=20 Mean-51.8 SD=0.74 CV%=1.43 Sample 2 N=20 Mean=44.6 SD=0.75 CV%=1.67 Sample i N=25 Mean=l8 SD=0.46 CV%=2.5 Sample 1 N=25 Mean=18 SD=0.37 CV%-2.0 Candidate Device Sample 2 N-25 Mean=49 SD=0.91 CV%=1.9 Sample 2 N=25 Mean-49 SD=1.04 CV%=2.0 Sample 3 N=25 Mean=97.5 SD=1.3 CV%=1.3 Sample 3 N=25 Mean-98 SD=1.14 CV%-I.1

Day to Day

Teco CX3 Reagent Set, the acceptability of CV% in BUN test is within 8%
1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 693-7788 Toll Free: 1-800-222-9880 Fax: (714) 693-3838 www.tecodiag.com EmaiI:tecodiag tecodiag.com

Calcium: Feature

Precision Within-Day

Predicate Device

Sample 1 N=20 Mean=9.1 SD=0.39 CV%=4.3 Sample 1 N=20 Mean-9.2 SD=0.21 CV%=2.2 Sample 2 N=20 Mean=13.7 SD=0.02 CV%=0.2 Sample 2 N=20 Mean=13.3 SD=0.32 CV%=2.4
Sample 1 N-25 Mean=9.1 SD-0.08 CV%=0.9 Sample 1 N=25 Mean-9.1 SD=0.09 CV%=I.O Sample 2 N=25 Mean=12.3 SD-O.11 CV%-0.9 Sample 2 N=25 Mean=12.4 SD=O.14 CV%=1.1 Sample 3 N=25 Mean=14 SD=O.16 CV%-0.8 Sample 3 N=25 Mean=14 SD=O.14 CV%-1.0
Teco CX3 Reagent Set, the acceptability of CV% in Calcium test is within 5%
Creatinine: Predicate Device Feature
Precision Within-Day Sample 1 N=20 Mean-1.9 SD=0.05 CV%=2.6 Sample 1 N=20 Mean=2.0 SD=0.2 CV%=10 Sample 2 N=20 Mean=8.2 SD=0.6 CV%=7.3 Sample 2 N=20 Mean=8.2 SD=0.4 CV%=4.6
Sample 1 N=25 Mean=1.3 SD-0.04 CV%=2.7 Sample 1 N=25 Mean=l.3 SD-0.03 CV%=2.2 Sample 2 N=25 Mean-6.4 SD-O.11 CV%=1.6 Sample 2 N=25 Mean=6.6 SD-0.24 CV%-3.7 Sample 3 N=25 Mean-20 SD-0.35 CV%=1.7 Sample 3 N-25 Mean=19.9 SD-0.33 CV%=1.6
Teco CX3 Reagent Set, the acceptability of CV% in Creatinine test is within 10%
1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 693-7788 Toll Free: 1-800-222-9880 Fax: (714) 693-3838 www.tecodiag.com Em aii:tecodiag tecodiag.com

Glucose:

Feature
Sample 1 N=20 Mean=87 SD-4.2 CV%=4.8 Sample I N=20 Mean=85 SD=3.7 CV%=4.3 Sample 2 N=20 Mean-282 SD-5.4 CV%=l.9 Sample 2 N=20 Mean=287 SD=9.6 CV%-3.3
Sample 1 N=25 Mean=78 SD=2.0 CV%=2.5 Sample 1 N=25 Mean=79 SD=2.6 CV%=3.3 Sample 2 N=25 Mean=255 SD=3.4 CV%=1.3 Sample 2 N=25 Mean-262 SD=5.9 CV%=2.2 Sample 3 N-25 Mean=735 SD=9.8 CV%=1.5 Sample 3 N=25 Mean=734 SD=8.7 CV%=1.2
Teco CX3 Reagent Set, the acceptability of CV% in Glucose test is within 10%
Table 2-Performance Characteristics (Human Serum) BUN:

Linearity Accuracy

3 to 102 mg/dL R:0.99 Y-1.00 -0.911
up to 80 mg/dL R=0.99 Y=0.962 X - 0.721
8-23 mg/L 15-39 mg/dL Expect values/ II Reference range Teco CX3 Reagent Set BUN test, Acceptance Criteria of Accuracy: r > 0.95; Slope: 0.97-1.1

Calcium:

1.0 to 15 mg/dL R-0.96 Y=i.07X +0.60 8.4-10.2 mg/dL
up to 20 mg/dL R=0.97 Y=0.94 X+ 0.53 8.5-10.5 mg/dL
Expect values/ Reference range Teco CX3 Reagent Set Calcium test, Acceptance Criteria of Accuracy: r > 0.90; Slope: 0.90-1.1

Creatinine:

0.2 to24g/dL R-0.99 Y=0.97 -0.11 0.6-1.3 mg/dL

Up to 25 mg/dL

R=0.99 Y=0.96 X+ 0.06 Male: 0.9-1.5 mg/dL values/ Expect Female: 0.7-1.37 mg/dL range Reference Teeo CX3 Reagent Set Creatinine test, Acceptance Criteria of Accuracy: r > 0.96; Slope: 0.90-1.1
30 to 750 mg/dL R=0.99 Y=0.96X+0.36 70-105 mg/dL
up to 500 mg/dL R=0.99 Y=1.02 X+3.1 70-106 mg/dL
Expect values/ Reference range Teco CX3 Reagent Set Glucose test, Acceptance Criteria of Accuracy: r > 0.90; Slope: 0.85-1.1
DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration MAR 2005
Ms. Jian Vaeches Teco Diagnostics 1268 N. Lakeview Ave Anaheim, CA 92807
2098 Gaither Road Rockville MD 20850
k060120 Trade/Device Name: Teco CX3 Reagent Set for SYNCHRON CX System Regulation Number: 21 CFR 862.1770 Regulation Name: Urea nitrogen test system Regulatory Class: Class II Product Code: CDQ, CIC, CGX, CGA Dated: March 16, 2006 Received: March 16, 2006
Dear Ms. Vaeches: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

Page 2 This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your-device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Guti eez, Ph.D.'

Director

Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure

Indications for Use

510(k) Number (if known): Device Name: k060120
Teco CX3 Reagent Set for SYNCHRON CX System
Indications For Use: Teco CX3 Reagent Set for SYNCHRON CX System is intended for the
quantitative determination of BUN, Calcium, Creatinine and Glucose in serum on Beckman CX3 System. BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. Calcium measurements are used in the diagnosis and treatment of parathyroid diseases, a variety of bone diseases, chronic renal and tetany. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and a calculation basis for measuring other urine analytes. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and pancreatic islet carcinoma. This reagent set is intended for in vitro diagnostic use only.

Prescription Use

(Part 21 CFR 801.109)

AND/OR

Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Page 1 of

Cct ofIn Vitro Diagnostic Device Lxuluation and Safety