TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM

{0}------------------------------------------------ MAR 2 7 2006 K060/20 Image /page/0/Picture/3 description: The image shows a black hexagon with the letters 'TC' in white inside. The letters are in a simple, sans-serif font and are stacked on top of each other. The hexagon is solid black, providing a strong contrast to the white letters. 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 Updated 510K summary Teco CX3 Reagent Set for SYNCHRON CX Contact Name: Jian Vaeches Phone Number: 714-693-7788 ext.131 Prepared Date: 03/20/2006 {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows a black hexagon with the letters "TC" in white inside. The letters are in a bold, sans-serif font and are centered within the hexagon. The hexagon is oriented with one point facing upwards. 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 #### Device Name The device trade names and common/classifications name are: | Device Trade Name | Common/Classification Name | |---------------------------------------------|-------------------------------------------| | Teco CX3 Reagent Set for SYNCHRON CX System | BUN, CALCIUM, CREATININE, GLUCOSE 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 ાં બે Teco CX3 Reagent Set has been classified as Class II with Product Code Lare, JPP, 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." #### 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 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows a black hexagon with the letters 'TC' in white inside. The letters are in a simple, sans-serif font and are stacked on top of each other. The overall design is clean and minimalist, with a high contrast between the black background and the white letters. 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 ## 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. | | Predicate Device | Candidate Device | |----------------|------------------------------------------------------------------------------------------------------------|------------------| | Packaging Size | | | | BUN | 5 x 25 ml & 5 x 5 ml | 500 ml | | Calcium | 4 x 120 ml | 500 ml | | Creatinine | 4 x 120 ml | 2000 ml | | Glucose | 4 x 120 ml | 500 ml | | Analyzer | General Chemistry Analyzers | SYSCHRON CX3 | | Components | | | | BUN | Tris Buffer 100 mmol<br>2-Oxoglutarate 5 mmol<br>Urease >20,000 U/L<br>GLDH > 1500 U/L<br>NADH 0.25 mmol/L | Urease >592 U/mL | #### Differences {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows a black hexagon with the letters "TC" in white inside. The letters are in a simple, sans-serif font and are stacked on top of each other. The hexagon is solid black, providing a strong contrast to the white letters. #### 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 | Calcium | O-Cresolphthalein Complexone 0.14 mM | Arsenazo III 0.15 mml/L | |------------|--------------------------------------|---------------------------| | | 8-Hydroxyquinoline 13 mM | | | | Diethylamide 363 mM | | | Creatinine | Picric Acid 10mM | Picric Acid 50mM | | | Sodium Hydroxide 240mM | Sodium Hydroxide 0.188 mM | | Glucose | Glucose Oxidase 15 u/ml | Glucose Oxidase 590 u/ml | | | Peroxidase 1.2 u/ml | Ethanol 10% | | | 4-Aminoantipyrine 0.38 mM | Potassium Iodide 0.04 mM | | | p-Hydroxybenzene Sulfonate 10 mM | | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows a black hexagon with the letters 'TC' in white inside. The letters are stylized and bold. The background is plain white. 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 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. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows a black hexagon with the letters "TC" in white inside. The letters are in a bold, sans-serif font and are centered within the hexagon. The hexagon is solid black, providing a strong contrast to the white letters. 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 ## TECO DIAGNOSTICS Image /page/5/Picture/4 description: The image shows a black hexagon with the letters "TC" in white inside. The letters are in a sans-serif font and are slightly offset from each other. The hexagon is oriented with one point facing upwards. 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 ### 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 1&2 below. The tests data can also be found in appendix C through F. # 1. Table 1 -- Performance Characteristics (Human Serum) | Feature | Predicate Device | | Candidate Device | | | |-------------------------|------------------|-----------|------------------|----------|-----------| | | Sample 1 | Sample 2 | Sample 1 | Sample 2 | Sample 3 | | Precision<br>Within-Day | N=20 | N=20 | N=25 | N=25 | N=25 | | | Mean=12.9 | Mean=51.8 | Mean=18 | Mean=49 | Mean=97.5 | | | SD=0.33 | SD=0.74 | SD=0.46 | SD=0.91 | SD=1.3 | | | CV%=2.62 | CV%=1.43 | CV%=2.5 | CV%=1.9 | CV%=1.3 | | Day to Day | Sample 1 | Sample 2 | Sample 1 | Sample 2 | Sample 3 | | | N=20 | N=20 | N=25 | N=25 | N=25 | | | Mean=12.4 | Mean=44.6 | Mean=18 | Mean=49 | Mean=98 | | | SD=0.15 | SD=0.75 | SD=0.37 | SD=1.04 | SD=1.14 | | | CV%=1.2 | CV%=1.67 | CV%=2.0 | CV%=2.0 | CV%=1.1 | Teco CX3 Reagent Set, the acceptability of CV% in BUN test is within 8% {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows a black hexagon with the letters "TC" in white inside. The letters are stacked on top of each other, with "T" on top and "C" on the bottom. The letters are in a bold, sans-serif font. The hexagon is solid black, and the letters are solid white. 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 ## Calcium: | Feature | Predicate Device | | | Candidate Device | | | |-------------------------|-------------------------------------------------------|--------------------------------------------------------|-------------------------------------------------------|--------------------------------------------------------|------------------------------------------------------|--| | Precision<br>Within-Day | Sample 1<br>N=20<br>Mean=9.1<br>SD=0.39<br>$CV\%=4.3$ | Sample 2<br>N=20<br>Mean=13.7<br>SD=0.02<br>$CV\%=0.2$ | Sample 1<br>N=25<br>Mean=9.1<br>SD=0.08<br>$CV\%=0.9$ | Sample 2<br>N=25<br>Mean=12.3<br>SD=0.11<br>$CV\%=0.9$ | Sample 3<br>N=25<br>Mean=14<br>SD=0.16<br>$CV\%=0.8$ | | | Day to Day | Sample 1<br>N=20<br>Mean=9.2<br>SD=0.21<br>$CV\%=2.2$ | Sample 2<br>N=20<br>Mean=13.3<br>SD=0.32<br>$CV\%=2.4$ | Sample 1<br>N=25<br>Mean=9.1<br>SD=0.09<br>$CV\%=1.0$ | Sample 2<br>N=25<br>Mean=12.4<br>SD=0.14<br>$CV\%=1.1$ | Sample 3<br>N=25<br>Mean=14<br>SD=0.14<br>$CV\%=1.0$ | | Teco CX3 Reagent Set, the acceptability of CV% in Calcium test is within 5% # Creatinine: | Feature | Predicate Device | | Candidate Device | | | |-------------------------|----------------------------------------------------|---------------------------------------------------|----------------------------------------------------|----------------------------------------------------|-----------------------------------------------------| | Precision<br>Within-Day | Sample 1<br>N=20<br>Mean=1.9<br>SD=0.05<br>CV%=2.6 | Sample 2<br>N=20<br>Mean=8.2<br>SD=0.6<br>CV%=7.3 | Sample 1<br>N=25<br>Mean=1.3<br>SD=0.04<br>CV%=2.7 | Sample 2<br>N=25<br>Mean=6.4<br>SD=0.11<br>CV%=1.6 | Sample 3<br>N=25<br>Mean=20<br>SD=0.35<br>CV%=1.7 | | Day to Day | Sample 1<br>N=20<br>Mean=2.0<br>SD=0.2<br>CV%=10 | Sample 2<br>N=20<br>Mean=8.2<br>SD=0.4<br>CV%=4.6 | Sample 1<br>N=25<br>Mean=1.3<br>SD=0.03<br>CV%=2.2 | Sample 2<br>N=25<br>Mean=6.6<br>SD=0.24<br>CV%=3.7 | Sample 3<br>N=25<br>Mean=19.9<br>SD=0.33<br>CV%=1.6 | Teco CX3 Reagent Set, the acceptability of CV% in Creatinine test is within 10% {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows a black hexagon with the letters "TC" in white inside. The letters are in a bold, sans-serif font. The hexagon is solid black, and the letters are centered within it. The image is simple and graphic. 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 ## Glucose: | Feature | Predicate Device | | Candidate Device | | | |-------------------------|--------------------------------------------------|---------------------------------------------------|--------------------------------------------------|---------------------------------------------------|---------------------------------------------------| | | Sample 1 | Sample 2 | Sample 1 | Sample 2 | Sample 3 | | Precision<br>Within-Day | N=20<br>Mean=87<br>SD=4.2<br>CV%=4.8 | N=20<br>Mean=282<br>SD=5.4<br>CV%=1.9 | N=25<br>Mean=78<br>SD=2.0<br>CV%=2.5 | N=25<br>Mean=255<br>SD=3.4<br>CV%=1.3 | N=25<br>Mean=735<br>SD=9.8<br>CV%=1.5 | | Day to Day | Sample 1<br>N=20<br>Mean=85<br>SD=3.7<br>CV%=4.3 | Sample 2<br>N=20<br>Mean=287<br>SD=9.6<br>CV%=3.3 | Sample 1<br>N=25<br>Mean=79<br>SD=2.6<br>CV%=3.3 | Sample 2<br>N=25<br>Mean=262<br>SD=5.9<br>CV%=2.2 | Sample 3<br>N=25<br>Mean=734<br>SD=8.7<br>CV%=1.2 | Teco CX3 Reagent Set, the acceptability of CV% in Clucose test is within 10% # Table 2-Performance Characteristics (Human Serum) BUN: | Feature | Candidate Device | Predicate Device | |-----------------------------------|---------------------------|--------------------------------| | Linearity | 3 to 102 mg/dL | up to 80 mg/dL | | Accuracy | R=0.99<br>Y= $1.00-0.911$ | R=0.99<br>Y= $0.962 X - 0.721$ | | Expect values/<br>Reference range | 15-39 mg/dL | 8-23 mg/L | Teco CX3 Reagent Set BUN test, Acceptance Criteria of Accuracy: r > 0.95; Slope: 0.97-1.1 ## Calcium: | Feature | Candidate Device | Predicate Device | |-----------------------------------|-------------------------|--------------------------| | Linearity | 1.0 to 15 mg/dL | up to 20 mg/dL | | Accuracy | R=0.96<br>Y=1.07X +0.60 | R=0.97<br>Y=0.94 X+ 0.53 | | Expect values/<br>Reference range | 8.4-10.2 mg/dL | 8.5-10.5 mg/dL | Teco CX3 Reagent Set Calcium test, Acceptance Criteria of Accuracy: r > 0.90; Slope: 0.90-1.1 {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows a black hexagon with the letters "TC" in white inside. The letters are in a bold, sans-serif font. The hexagon is solid black, and the white letters stand out against the dark background. The logo appears simple and modern. 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 ## Creatinine: | Feature | Candidate Device | Predicate Device | |-----------------------------------|----------------------------|-----------------------------------------------| | Linearity | 0.2 to24g/dL | Up to 25 mg/dL | | Accuracy | $R=0.99

lt;br>$Y=0.97 -0.11$ | $R=0.99

lt;br>$Y=0.96 X+ 0.06$ | | Expect values/<br>Reference range | 0.6-1.3 mg/dL | Male: 0.9-1.5 mg/dL<br>Female: 0.7-1.37 mg/dL | Teco CX3 Reagent Set Creatinine test, Acceptance Criteria of Accuracy: r > 0.96; Slope: 0.90-1.1 # Glucose: | Feature | Candidate Device | Predicate Device | |-----------------------------------|------------------------|------------------------| | Linearity | 30 to 750 mg/dL | up to 500 mg/dL | | Accuracy | R=0.99<br>Y=0.96X+0.36 | R=0.99<br>Y=1.02 X+3.1 | | Expect values/<br>Reference range | 70-105 mg/dL | 70-106 mg/dL | Teco CX3 Reagent Set Glucose test, Acceptance Criteria of Accuracy: r > 0.90; Slope: 0.85-1.1 {9}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and a caduceus intertwined with the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white. Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 MAR 2 7 2006 Ms. Jian Vaeches Teco Diagnostics 1268 N. Lakeview Ave Anaheim, CA 92807 Re: 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). {10}------------------------------------------------ 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 vours. Alberto Gutierrez Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {11}------------------------------------------------ # Indications for Use ## 510(k) Number (if known): k060120 # Device Name: 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 J AND/OR Over-The-Counter Use (Part 21 CFR 801.109) (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 1 Of In Vitro Diagnostic Device Evaluation and Safe n Sign-Off 060120