← Product Code [DCK](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK) · K963061 # IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT (K963061) _Beckman Instruments, Inc. · DCK · Nov 4, 1996 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K963061 ## Device Facts - **Applicant:** Beckman Instruments, Inc. - **Product Code:** [DCK](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK.md) - **Decision Date:** Nov 4, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5270 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Indications for Use The IMMAGE Immunochemistry Systems C-reactive protein (CRP) reagent, in conjunction with Beckman CAL 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with Beckman's IMMAGE Immunochemistry System. ## Device Story The IMMAGE Immunochemistry System CRP reagent is an in vitro diagnostic assay used for the quantitative measurement of C-reactive protein in human serum and plasma. The device utilizes rate nephelometry and latex particle-enhanced immunochemistry to detect CRP concentrations. It is designed for operation on the Beckman IMMAGE Immunochemistry System in a clinical laboratory setting by trained laboratory personnel. The system processes samples to produce a quantitative concentration value, which is reported to the healthcare provider. This output assists clinicians in evaluating inflammatory states in patients. The reagent is provided in a liquid stable form, offering improved stability compared to lyophilized alternatives. ## Clinical Evidence Bench testing only. Method comparison study against Behring N Latex CRP (n=not specified) yielded a slope of 1.037, intercept of -0.06, and correlation coefficient (r) of 0.991. Imprecision studies demonstrated within-run %CVs ranging from 1.8% to 8.1% across three concentration levels (1.65–12.6 mg/dL). Stability data confirms a 24-month shelf-life and 14-day open-container/calibration stability. ## Technological Characteristics Latex particle-enhanced immunochemistry; rate nephelometry detection principle. Reagent is liquid stable. Uses goat-derived antibodies. Designed for use on the IMMAGE Immunochemistry System. No specific ASTM material standards or connectivity protocols provided. ## Regulatory Identification A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. ## Predicate Devices - Behring N Latex CRP ## 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 NOV - 4 1996 BECKMAN Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System C-Reactive Protein (CRP) Reagent K963061 Revised Dmc: Dated 10/4/96 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: 06 Aug-1996 3.0 Device Name(s): 3.1 Proprietary Names IMMAGE™ Immunochemistry System C-Reactive Protein (CRP) Reagent 3.2 Classification Names C-reactive protein immunological test system(21 CFR 866.5270) 4.0 Predicate Device(s): Behring N Latex CRP 5.0 Description: The IMMAGE Immunochemistry Systems C-reactive protein (CRP) reagent, in conjunction with Beckman CAL 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples. 6.0 Intended Use: The IMMAGE Immunochemistry Systems C-reactive protein (CRP) reagent, in conjunction with Beckman CAL 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with Beckman's IMMAGE Immunochemistry System. file: irf510k.see Beckman Instruments, Inc. twx: 910-592-1260 • telex: 06-78413 {1} Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System C-Reactive Protein (CRP) 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 (CRP) Reagent | Intended Use | Same as Behring N Latex CRP | | | Nephelometric methodology | Same as Behring N Latex CRP | | | Use of Latex particle technology | Same as Behring N Latex CRP | | DIFFERENCES | | | | IMMAGE System (CRP) Reagent | Form of reagent | the IMMAGE CRP is liquid stable while Behring N Latex CRP reagent is lyophilized | | | Antibody source | IMMAGE CRP uses goat while Behring N Latex CRP uses rabbit. | | | Stability | IMMAGE CRP is stable for 14 days once opened, properly stored while Behring N Latex CRP reagent is stable for one week following reconstitution,. | file: crp510k.sse {2} Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System C-Reactive Protein (CRP) Reagent Summary of Safety & Effectiveness 3 ## 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 Behring N Latex CRP Reagent to the IMMAGE CRP Reagent. ### Method Comparison Study Results IMMAGE CRP Reagent vs. Behring N Latex CRP Reagent | Analyte | Slope | Intercept | r | Predicate | | --- | --- | --- | --- | --- | | IMMAGE CRP | 1.037 | -0.06 | 0.991 | Behring N Latex CRP | ### Stability Study Results | Reagent | Product Claim | | --- | --- | | IMMAGE CRP | 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 | | --- | --- | --- | --- | --- | | CRP Reagent | | | | | | Level 1 | 1.65 | 0.134 | 8.1 | 80 | | Level 2 | 5.41 | 0.165 | 3.1 | 80 | | Level 3 | 12.6 | 0.22 | 1.8 | 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: crp510k.sse --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K963061](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K963061) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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