SYNCHRON SYSTEMS THYROXINE REAGENT

{0} Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON Systems Thyroxine (T4) Reagent Summary of Safety & Effectiveness K971203 MAY 16 1997 Summary of Safety & Effectiveness SYNCHRON Systems Thyroxine (T4) Reagent ## 1.0 Submitted By: Lucinda Stockert Senior Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 961-3777 FAX: (714) 961-4457 ## 2.0 Date Submitted: 7 May 1997 ## 3.0 Device Name(s): ### 3.1 Proprietary Names SYNCHRON® Systems Thyroxine (T4) Reagent ### 3.2 Classification Name Total thyroxine test system (21 CFR § 862.1700) ## 4.0 Predicate Device(s): | SYNCHRON Reagent | Predicate | Predicate Company | Docket Number | | --- | --- | --- | --- | | SYNCHRON Systems Thyroxine (T4) Reagent | CEDIA T4 MAb Reagent | Boehringer Mannheim Corp., | K935880 | | SYNCHRON Systems Thyroxine (T4) Reagent | CEDIA T4 MAb Reagent- SYNCHRON Application | Boehringer Mannheim Corp., | K942575 | t4_510k.sse {1} Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON Systems Thyroxine (T4) Reagent Summary of Safety & Effectiveness # 5.0 Description: The SYNCHRON Systems Thyroxine (T4) Reagent kit, which includes the T4 Reagent and the T4 Calibrators, in intended for use on Beckman's SYNCHRON Clinical Systems. # 6.0 Intended Use: The SYNCHRON Systems Thyroxine (T4) Reagent is intended for the quantitative determination of total thyroxine concentrations in serum on SYNCHRON Clinical Systems. # 7.0 Comparison to Predicate(s): The following tables show similarities and differences between the predicates identified in Section 4.0 of this summary. ## SIMILARITIES to the PREDICATE | Reagent | Aspect/Characteristic | Comments | | --- | --- | --- | | SYNCHRON Systems Thyroxine (T4) Reagent | Intended use | Same as the predicate | | | Chemical Reaction | Same principle as the predicate | | | Formulation | Same source, processing as predicate | | | Calibration | Same as the predicate | | | Reagent Kit Configuration | Same as the predicate | ## DIFFERENCES from the PREDICATE | Reagent | Aspect/Characteristic | Comments | | --- | --- | --- | | SYNCHRON Systems Thyroxine (T4) Reagent | Specimen Type | SYNCHRON T4 Reagent claims Sodium Heparin and Lithium Heparin as acceptable anticoagulants while the Boehringer Mannheim CEDIA T4 MAb Reagent claims Sodium Heparin, Lithium Heparin, and Sodium EDTA as acceptable anticoagulants. | file: t4_510k.sse {2} Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON Systems Thyroxine (T4) Reagent Summary of Safety & Effectiveness ## 8.0 Summary of Performance Data: The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, imprecision studies, and stability studies that relate results obtained from the SYNCHRON Systems Thyroxine (T4) Reagent and the Boehringer Mannheim CEDIA MAb Thyroxine Reagent with a SYNCHRON Application. ### Method Comparison Study Results #### SYNCHRON Systems T4 Reagent | Analyte (Reagent) | Slope | Intercept (μg/dL) | r | n | Predicate Method | | --- | --- | --- | --- | --- | --- | | Thyroxine (T4) | 1.018 | 0.12 | 0.992 | 97 | Boehringer Mannheim CEDIA MAb Thyroxine Reagent | ### Estimated Imprecision #### SYNCHRON Systems T4 Reagent | Sample | Mean (μg/dL) | S.D. (μg/dL) | %C.V. | N | | --- | --- | --- | --- | --- | | Within-Run Imprecision | | | | | | Level 1 | 4.2 | 0.2 | 4.3 | 80 | | Level 2 | 8.6 | 0.2 | 2.4 | 80 | | Level 3 | 17.1 | 0.3 | 1.7 | 80 | | Total Imprecision | | | | | | Level 1 | 4.2 | 0.4 | 8.8 | 80 | | Level 2 | 8.6 | 0.4 | 4.3 | 80 | | Level 3 | 17.1 | 0.4 | 2.4 | 80 | ### On-Board Stability Study Results | Reagent | Product Claim | | --- | --- | | SYNCHRON Thyroxine (T4) | 30 days | This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92. file: t4_510k.sse