← Product Code [DDG](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDG) · K963427 # IMMAGE IMMUNOCHEMISTRY SYSTEM TRANSFERRIN (TRF) REAGENT (K963427) _Beckman Instruments, Inc. · DDG · Oct 7, 1996 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDG/K963427 ## Device Facts - **Applicant:** Beckman Instruments, Inc. - **Product Code:** [DDG](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDG.md) - **Decision Date:** Oct 7, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5880 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Indications for Use The IMMAGE Immunochemistry System Transferrin (TRF) reagent, in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of transferrin concentrations in human serum samples by rate nephelometry. ## Device Story The IMMAGE Immunochemistry System Transferrin (TRF) Reagent is an in vitro diagnostic reagent used on the Beckman IMMAGE Immunochemistry System. It utilizes rate nephelometry to measure transferrin concentrations in human serum. The system processes samples using a reagent cartridge, evaporation caps, and a lot-specific bar code card. The assay involves an antibody-antigen reaction; the rate of light scattering is measured to determine analyte concentration. The device is intended for clinical laboratory use. Results are provided to healthcare providers to assist in clinical decision-making regarding patient iron metabolism and nutritional status. ## Clinical Evidence Bench testing only. Method comparison study between IMMAGE TRF and ARRAY system predicate showed a slope of 0.990, intercept of 0.692, and r=0.994. Within-run imprecision studies (n=80 per level) yielded %CVs of 3.1% (241 mg/dL), 3.9% (361 mg/dL), and 2.9% (653 mg/dL). Stability studies confirmed 24-month shelf-life and 14-day open-container/calibration stability. ## Technological Characteristics Rate nephelometry assay. Reagent provided in plastic cartridges. Analytical range: 75-750 mg/dL; extended range: 12.5-4,500 mg/dL. Operates at 37°C. Storage: 2-8°C. ## 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 Immunochemistry Systems TRF Transferrin Reagent ## Reference Devices - ARRAY® System ## 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} OCT 7 1996 Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Transferrin (TRF) Reagent Summary of Safety & Effectiveness K963427 # Summary of Safety & Effectiveness ## IMMAGE™ Immunochemistry System Transferrin (TRF) Reagent ### 1.0 Submitted By: Margie George Project Manager, System Development Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 961-3765 FAX: (714) 961-3759 ### 2.0 Date Submitted: 30 August 1996 ### 3.0 Device Name(s): #### 3.1 Proprietary Names IMMAGE™ Immunochemistry System Transferrin (TRF) Reagent #### 3.2 Classification Names Transferrin immunological test system (21 CFR 866.5880) ### 4.0 Predicate Device(s): Beckman Immunochemistry Systems TRF Transferrin Reagent ### 5.0 Description: The IMMAGE Immunochemistry System Transferrin (TRF) Reagent is used in the determination of transferrin concentrations in human serum samples on Beckman's IMMAGE Immunochemistry System. The reagent kit contains one cartridge of reagent, evaporation caps and a lot specific bar code card. Calibrators and control materials are purchased separately. file: trf510k.sse, 8/96 {1} Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Transferrin (TRF) Reagent Summary of Safety & Effectiveness ## 6.0 Intended Use: The IMMAGE Immunochemistry System Transferrin (TRF) reagent, in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of transferrin concentrations in human serum samples by rate nephelometry. ## 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 (TRF) Reagent | Assay method - rate nephelometry | Same as Beckman's Immunochemistry System Transferrin TRF Reagent as run on the ARRAY® System | | | Analytic Range 75 - 750 mg/dL Extended Range 12.5 - 4,500 mg/dL | | | | Sample and reagent ratios | | | | Antibody | | | | Shelf life of 24 months (stored at 2 -8°C) | | | DIFFERENCES | | | | IMMAGE System (TRF) Reagent | Reaction Temperature | IMMAGE System TRF assays run at 37°C and the predicate runs at 26.7°C | | | Reagent container | IMMAGE reagent is stored in a plastic cartridge where as the predicate is stored in glass. | file: trf510k.sse, 8/96 {2} Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Transferrin (TRF) 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 Beckman's Immunochemistry System TRF Transferrin (on ARRAY) Reagent to the IMMAGE System TRF Reagent. ### Method Comparison Study Results IMMAGE TRF Reagent vs. Beckman TRF Transferrin Reagent (on ARRAY) | Analyte | Slope | Intercept | r | Predicate | | --- | --- | --- | --- | --- | | IMMAGE TRF | 0.990 | 0.692 | 0.994 | Beckman's TRF Transferrin Reagent on the ARRAY® Systems | ### Stability Study Results | Reagent | Product Claim | | --- | --- | | IMMAGE TRF Reagent System | 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 | | --- | --- | --- | --- | --- | | TRF Reagent | | | | | | Level 1 | 241 | 7.4 | 3.1 | 80 | | Level 2 | 361 | 14.0 | 3.9 | 80 | | Level 3 | 653 | 18.9 | 2.9 | 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: trf510k.sse, 8/96 --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDG/K963427](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDG/K963427) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com