← Product Code [DDG](/productcode/DDG) · K963976 # IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT (K963976) _Beckman Instruments, Inc. · DDG · Mar 19, 1997 · Immunology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K963976 ## Device Facts - **Applicant:** Beckman Instruments, Inc. - **Product Code:** [DDG](/productcode/DDG.md) - **Decision Date:** Mar 19, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5880 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Indications for Use The IMMAGE Immunochemistry System Urine Transferrin (TRU) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Urine Protein Calibrator, is intended for the quantitative determination of transferrin in urine by rate nephelometry. ## Device Story IMMAGE Immunochemistry System Urine Transferrin (TRU) reagent performs quantitative determination of transferrin in human urine. System utilizes rate nephelometry; reagent cartridge includes integrated antigen excess testing solution. Operated by laboratory personnel on Beckman IMMAGE Immunochemistry Systems. Output is quantitative transferrin concentration (mg/dL). Provides clinical data for renal function assessment. ## Clinical Evidence Bench testing only. Method comparison study (n=103) against predicate yielded slope 1.111, intercept -0.04, r=0.998. Within-run imprecision (n=80 per level) showed %CV of 2.6-2.7% across levels 0.38-3.02 mg/dL. Stability studies support 24-month shelf-life, 14-day open container, and 14-day calibration stability. ## Technological Characteristics Rate nephelometry; goat-derived antibody reagent; integrated antigen excess testing solution; automated system-based analysis. ## Regulatory Identification A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia. ## Predicate Devices - Beckman Transferrin Kit ([K926272](/device/K926272.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 200 South Kraemer Boulevard, Box 8000, Brea, CA 92822-8000 • (714) 993-5321 # BECKMAN ## K963976 Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Urine Transferrin (TRU) Reagent MAR 19 1997 ### 1.0 Submitted By: Annette Hellie Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4457 ### 2.0 Date Submitted: 30 September 1996 ### 3.0 Device Name(s): #### 3.1 Proprietary Name IMMAGE™ Immunochemistry System Urine Transferrin (TRU) Reagent #### 3.2 Classification Name Transferrin Test System (21 CFR § 866.5880) ### 4.0 Predicate Device(s): Beckman Transferrin Kit (Urine application) K926272 ### 5.0 Description: The IMMAGE Immunochemistry System Urine Transferrin (TRU) reagent, in conjunction with Beckman's Urine Protein Calibrator, is intended for use in the quantitative determination of transferrin in human urine samples. ### 6.0 Intended Use: The IMMAGE Immunochemistry System Urine Transferrin (TRU) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Urine Protein Calibrator, is intended for the quantitative determination of transferrin in urine by rate nephelometry. file: tru510k.sse Beckman Instruments, Inc. twx: 910-592-1260 • telex: 06-78413 {1} Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Urine Transferrin (TRU) Reagent Summary of Safety & Effectiveness # 7.0 Comparison to Predicate(s): The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary. | Reagent | Aspect/Characteristic | Comments | | --- | --- | --- | | SIMILARITIES | | | | IMMAGE System TRU Reagent | Analytic Range | Same as Beckman Transferrin Kit reagent | | | Nephelometric methodology | | | | Antibody source (goat) | | | DIFFERENCES | | | | IMMAGE System TRU Reagent | Antigen excess testing | IMMAGE TRU has antigen excess testing solution included in the reagent cartridge, while the Beckman Transferrin Kit requires off-line preparation of the solution. | | | Antibody concentration | IMMAGE TRU has a higher antibody concentration than the Beckman Transferrin Kit | file: tru510k.sse {2} Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Urine Transferrin (TRU) 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, stability, and imprecision experiments that relate results obtained from the Beckman Transferrin Kit Reagent to the IMMAGE TRU Reagent. ### Method Comparison Study Results IMMAGE TRU Reagent vs. Beckman Transferrin Kit Reagent | Analyte | Slope | Intercept | r | n | Predicate | | --- | --- | --- | --- | --- | --- | | IMMAGE TRU | 1.111 | -0.04 | 0.998 | 103 | Beckman Transferrin Kit | ### Stability Study Results | Reagent | Product Claim | | --- | --- | | IMMAGE TRU | 24 month shelf-life 14 day open container stability 14 day calibration stability | ### Estimated Within-Run Imprecision | MATERIAL | MEAN (mg/dL) | SD (mg/dL) | %CV | Number of Results | | --- | --- | --- | --- | --- | | TRU Reagent | | | | | | Level 1 | 0.38 | 0.010 | 2.7 | 80 | | Level 2 | 1.55 | 0.041 | 2.6 | 80 | | Level 3 | 3.02 | 0.077 | 2.6 | 80 | 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: tru510k.sse --- **Source:** [https://fda-staging.innolitics.com/device/K963976](https://fda-staging.innolitics.com/device/K963976) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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