← Product Code [DEW](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEW) · K963974 # IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN (K963974) _Beckman Instruments, Inc. · DEW · Mar 6, 1997 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEW/K963974 ## Device Facts - **Applicant:** Beckman Instruments, Inc. - **Product Code:** [DEW](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEW.md) - **Decision Date:** Mar 6, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5510 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Indications for Use The IMMAGE Immunochemistry System Urine Immunoglobulin G (IGU) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Urine Protein Calibrator, is intended for the quantitative determination of Immunoglobulin G in urine by rate nephelometry. ## Device Story The IMMAGE Immunochemistry System Urine Immunoglobulin G (IGU) reagent is an in vitro diagnostic reagent used with the Beckman IMMAGE Immunochemistry System. It utilizes rate nephelometry to measure Immunoglobulin G (IgG) concentrations in human urine. The system processes samples automatically, incorporating an integrated antigen excess testing solution within the reagent cartridge to ensure measurement accuracy. The device is intended for use in clinical laboratory settings by trained personnel. Results are provided to clinicians to assist in the assessment of renal function and protein excretion. The system improves workflow efficiency compared to manual off-line preparation methods required by previous predicate systems. ## Clinical Evidence Bench testing only. Method comparison study (n=115) against the predicate device yielded a slope of 1.00, intercept of 0.00, and r=0.998. Within-run imprecision studies (n=80 per level) showed %CVs of 10.2% at 0.38 mg/dL, 2.7% at 2.66 mg/dL, and 2.7% at 5.20 mg/dL. Stability data supports a 24-month shelf-life, 14-day open container stability, and 14-day calibration stability. ## Technological Characteristics Rate nephelometry assay; goat-derived anti-IgG antibodies; integrated antigen excess testing solution; reagent cartridge form factor; automated processing on IMMAGE Immunochemistry System. ## Regulatory Identification An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. ## Predicate Devices - Beckman Immunoglobulin G (IGG) Test System (Urine application) ([K951635](/device/K951635.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 K963974 MMR - 6 1997 # BECKMAN Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Urine Immunoglobulin G (IGU) Reagent ## 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 Immunoglobulin G (IGU) Reagent ### 3.2 Classification Name Immunoglobulins A, G, M, D, and E immunological test system (21 CFR § 866.5510) ## 4.0 Predicate Device(s): Beckman Immunoglobulin G (IGG) Test System (Urine application) K951635 ## 5.0 Description: The IMMAGE Immunochemistry System Urine Immunoglobulin G (IGU) reagent, in conjunction with Beckman's Urine Protein Calibrator, is intended for use in the quantitative determination of Immunoglobulin G in human urine samples. ## 6.0 Intended Use: The IMMAGE Immunochemistry System Urine Immunoglobulin G (IGU) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Urine Protein Calibrator, is intended for the quantitative determination of Immunoglobulin G in urine by rate nephelometry. file: igu510k.sse Beckman Instruments, Inc. twx: 910-592-1260 • telex: 06-78413 {1} Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Urine Immunoglobulin G (IGU) 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 IGU Reagent | Analytic Range | Same as Beckman IGG Test System reagent | | | Nephelometric methodology | | | | Antibody source (goat) | | | DIFFERENCES | | | | IMMAGE System IGU Reagent | Antigen excess testing | IMMAGE IGU has antigen excess testing solution included in the reagent cartridge, while the Beckman IGG Test System requires off- line preparation of the solution. | | | Antibody concentration | IMMAGE IGU has a higher antibody concentration than the Beckman IGG Test System | file: igu510k.sse {2} Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Urine Immunoglobulin G (IGU) 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 Immunoglobulin G Test System Reagent to the IMMAGE IGU Reagent. ### Method Comparison Study Results IMMAGE IGU Reagent vs. Beckman Immunoglobulin G Kit Reagent | Analyte | Slope | Intercept | r | n | Predicate | | --- | --- | --- | --- | --- | --- | | IMMAGE IGU Reagent | 1.00 | 0.00 | 0.998 | 115 | Beckman (IGG) Test System | ### Stability Study Results | Reagent | Product Claim | | --- | --- | | IMMAGE IGU | 24 month shelf-life 14 day open container stability 14 day calibration stability | ### Estimated Within-Run Imprecision | MATERIAL | MEAS (mg/dL) | SD (mg/dL) | %CV | Number of Results | | --- | --- | --- | --- | --- | | IGU Reagent | | | | | | Level 1 | 0.38 | 0.038 | 10.2 | 80 | | Level 2 | 2.66 | 0.071 | 2.7 | 80 | | Level 3 | 5.20 | 0.140 | 2.7 | 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: igu510k.sse --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEW/K963974](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEW/K963974) **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