The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.

Device Description

The IMMAGE Systems Rheumatoid Factor (RF) Reagent is designed for optimal performance on the IMMAGE Immunochemistry System. It is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the IMMAGE™ Immunochemistry System Rheumatoid Factor (RF) Reagent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Method Comparison (vs. Behring N Latex RF Reagent)	The document states "Equivalence is demonstrated through method comparison..." but does not provide specific quantitative acceptance criteria (e.g., correlation coefficient, bias limits) or the actual calculated values for these metrics. The provided table in Section 8.0 is largely illegible.
Stability (Shelf-life)	24 months shelf-life
Stability (Open Container)	14 day open container stability
Stability (Calibration)	14 day calibration stability
Within-Run Imprecision (Level 1)	Mean: 124 IU/mL, SD: 2.5 IU/mL, %CV: 2.1
Within-Run Imprecision (Level 2)	Mean: 299 IU/mL, SD: 4.5 IU/mL, %CV: 1.5
Within-Run Imprecision (Level 3)	Mean: 637 IU/mL, SD: 12.4 IU/mL, %CV: 1.9

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Method Comparison: The document does not explicitly state the number of samples used for the method comparison study. The table in Section 8.0 appears to contain data but is unreadable.
Data Provenance: Not specified within the provided text (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable as the device is an in vitro diagnostic (IVD) reagent for quantitative determination of rheumatoid factor in serum/plasma. Its performance is evaluated against a predicate device and established analytical metrics (stability, imprecision), not by human expert interpretation of results. Therefore, there's no "ground truth" established by experts in the context of diagnostic interpretation.

4. Adjudication Method for the Test Set

This is not applicable for an IVD reagent performance study. Adjudication methods like 2+1 or 3+1 are used for studies involving human interpretation (e.g., imaging studies) where there might be disagreement in ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable. The device is an IVD reagent and not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a chemical reagent, not an algorithm. Its performance is inherently standalone in that it produces a quantitative result without human interpretive input. The study focuses on the analytical performance of the reagent on the IMMAGE Immunochemistry System.

7. The Type of Ground Truth Used

For Method Comparison: The "ground truth" is effectively the results obtained using the Behring N Latex RF Reagent (predicate device). The study aimed to demonstrate substantial equivalence by correlating results from the new device with the predicate.
For Stability and Imprecision: The "ground truth" (or reference) is based on established analytical standards and measurements, ensuring the device yields accurate and reproducible results over time and within a run.

8. The Sample Size for the Training Set

This is not applicable. As a chemical reagent, there is no "training set" in the machine learning sense. The reagent's formulation and associated system parameters are developed through chemical and engineering processes, not through machine learning training.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons stated in point 8.

Summary

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BECKMAN

K96 3048

Summary of Safety & Effectiveness

IMMAGE™ Immunochemistry System Rheumatoid Factor (RF) 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:

05 Aug-1996

3.0 Device Name(s):

3.1 Proprietary Names

IMMAGE™ Immunochemistry System Rheumatoid Factor (RF) Reagent

3.2 Classification Names

Rheumatoid factor immunological test system(21 CFR 866.5775)

4.0 Predicate Device(s):

Behring Diagnostics N Latex RF, K942328

5.0 Description:
The IMMAGE Systems Rheumatoid Factor (RF) Reagent is designed for optimal performance on the IMMAGE Immunochemistry System. It is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples.

6.0 Intended Use:

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Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Rheumatoid Factor (RF) Reagent Summary of Safety & Effectiveness

Comparison to Predicate(s): 7.0

The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.

Reagent	Aspect/Characteristic	Comments
SIMILARITIES
IMMAGE SystemRF Reagent	Intended use	Same as BehringN Latex RF
IMMAGE SystemRF Reagent	Nephelometric methodology	Same as BehringN Latex RF
IMMAGE SystemRF Reagent	Latex particle technology -	Same as BehringN Latex RF
DIFFERENCES
IMMAGE SystemRF Reagent	Form of reagent	IMMAGE RF is a liquid stablereagent, while BehringN Latex RF is lyophilized.
IMMAGE SystemRF Reagent	Stability	IMMAGE RF reagent isstable for 14 days onceopened, properly stored,while Behring N Latex RFreagent is stable for oneweek following reconstitution

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Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Rheumatoid Factor (RF) Reagent Summary of Safety & Effectiveness

Summary of Performance Data: 8.0

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 RF Reagent to the IMMAGE System RF Reagent.

Method Comparison Study Results IMMAGE RF Reagent vs. Behring N Latex RF Reagent

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Stability Study Results

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Reagent	Product Claim
IMMAGE RF	24 months shelf-life14 day open container14 day calibration

Estimated Within-Run Imprecision

MATERIAL	MEAN(IU/mL)	SD(IU/mL)	%CV	Number ofResults
	IMMAGE System RF Reagent
Level 1	124	2.5	2.1	80
Level 2	299	4.5	1.5	80
Level 3	637	12.4	1.9	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.

Regulation Number and Section

§ 866.5775 Rheumatoid factor immunological test system.

(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).