The IMMAGE Immunochemistry System Apoliooprotein A-1 (APA) and B (APB) Reagents, in conjunction with Beckman Apolipoprotein Calibrator (APO Cal), are intended for use in the quantitative determination of apolipoprotein A-1 and B in human serum samples by nephelometric immunoassay. These assays are designed for use with the IMMAGE Immunochemistry System.

Device Description

The IMMAGE System Apolipoprotein A-1 (APA) and B (APB) Reagents are designed for optimal performance on the IMMAGE Immunochemistry System. They are intended for use in the quantitative determination of apolipoprotein A-1 and B concentrations in human serum samples.

AI/ML Overview

The provided document describes the safety and effectiveness of the IMMAGE Immunochemistry System Apolipoprotein A-1 (APA) and B (APB) Reagents. The study is a comparison to predicate devices, focusing on method comparison, stability, and imprecision.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for each performance metric, but the "Summary of Performance Data" section implies that the presented results demonstrate substantial equivalence to the predicate devices. For a more formal acceptance criteria, one would typically expect predefined thresholds for slope, intercept, r-value, and imprecision (%CV). However, for the purpose of this analysis, we will interpret "device performance" as the reported results, benchmarked against the predicate devices.

Performance Metric	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (IMMAGE APA Reagent)	Reported Device Performance (IMMAGE APB Reagent)
Method Comparison
Slope	Close to 1 (indicating proportional agreement)	0.998	1.030
Intercept	Close to 0 (indicating no constant bias)	1.86	-1.34
Correlation (r)	High (indicating strong linear relationship)	0.983	0.991
Stability
Shelf-life	24 months (consistent with predicate performance)	24 months	24 months
On-board/Open Container Stability	14 days (consistent with predicate performance)	14-day on board	14 open container stability
Calibration Stability	14 days (consistent with predicate performance)	14 day calibration stability	14 day calibration stability
Imprecision
Within-run %CV (Level 1)	Low %CV (indicating good reproducibility)	5.5	3.2
Within-run %CV (Level 2)	Low %CV	3.2	2.5
Within-run %CV (Level 3)	Low %CV	2.9	2.5

Note: The "Acceptance Criteria" column above is inferred based on the goal of showing "substantial equivalence" to existing commercial distribution devices. For a regulatory submission, explicit numerical thresholds would typically be defined beforehand.

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

Sample Size for Test Set: The document explicitly states the "Number of Results" for the imprecision study as 80 for each level (Level 1, Level 2, Level 3) for both APA and APB reagents. This sums to 240 measurements for APA and 240 for APB, totaling 480 individual results for the imprecision study. The sample size for the method comparison study (which produces the slope, intercept, and r-value) is not explicitly stated in the provided text.
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It is implied to be a prospective study conducted by Beckman Instruments, Inc. for the purpose of demonstrating device performance.

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

This document describes a diagnostic reagent and system for quantitative determination of apolipoproteins, not an imaging device or a diagnostic algorithm requiring human expert interpretation. Therefore, the concept of "experts" establishing a "ground truth" for a test set in the conventional sense (e.g., radiologists interpreting images) does not directly apply here.

Ground Truth Establishment: For in vitro diagnostic devices like this, "ground truth" is typically established by comparing the new device's results against a well-characterized and often established reference method (the predicate device in this case) or gravimetrically prepared standards for imprecision and linearity studies. The "experts" would be the laboratory personnel performing the experiments and verifying instrument calibration and control material concentrations. Their qualifications would typically involve appropriate clinical laboratory training and experience.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective interpretation (e.g., image reading) where disagreement among experts needs resolution. This concept does not apply to the quantitative measurement of apolipoproteins by an immunochemistry system. The results are numerical values, and any discrepancies would be investigated through quality control, calibration checks, or re-testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. MRMC studies are relevant for assessing the impact of a new diagnostic tool on human reader performance, particularly in fields like radiology where subjective interpretation is key. This document describes a quantitative in vitro diagnostic device, where the comparison is system-to-system, not human-reader-to-human-reader or human-reader-with-AI vs. human-reader-without-AI.

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

Yes, the studies presented (method comparison, stability, imprecision) represent standalone performance of the IMMAGE™ Immunochemistry System and its reagents. These studies evaluate the analytical performance of the device itself, providing quantitative results without direct human intervention in the result generation process (beyond initiating tests and quality control). The "human-in-the-loop" aspect for such a device would be a laboratory technician operating the instrument and interpreting the numerical output, but the performance data here is about the device's accuracy and precision in generating those numbers.

7. The Type of Ground Truth Used

For the method comparison study, the "ground truth" was essentially the measurements obtained from the predicate devices (Beckman Apolipoprotein A-1 Reagent on the ARRAY and Beckman Apolipoprotein B Reagent on the ARRAY). The study aimed to demonstrate substantial equivalence by showing a strong correlation and agreement between the new IMMAGE system and the established predicate.

For the imprecision study, the "ground truth" for the mean concentration values would be based on assigned values of control materials (e.g., derived from manufacturers' assays or reference methods), with the goal of demonstrating consistent and reproducible measurements around those values.

8. The Sample Size for the Training Set

The document does not describe the development of an algorithm or AI model that would require a "training set." This device is an immunochemistry system with specific reagents, not a machine learning or AI-based diagnostic tool. Therefore, the concept of a "training set" in this context is not applicable.

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

As explained in point 8, there is no "training set" for this type of device. The ground truth for validating the analytical performance involves comparison against established predicate methods and control materials with known values, as detailed in point 7.

Summary

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FEB

1997

K964010

Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Apolipoprotein A-1 (APA) and B (APB) Reagents

1.0 Submitted By:

Margie George Project Manager, Systems 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:

03 Oct 1996

3.0 Device Name(s):

3.1 Proprietary Names

IMMAGE™ Immunochemistry System Apolipoprotein A-1 Reagent IMMAGE™ Immunochemistry System Apolipoprotein B Reagent

3.2 Classification Names

Lipoprotein test system (21 CFR 862.1475)

4.0 Predicate Device(s):

Beckman Immunochemistry Systems Apolipoprotein A-1 Reagent, K862019 Beckman Immunochemistry Systems Apolipoprotein B Reagent, K 862386

5.0 Description:

6.0 Intended Use:

Beckman Instruments, Inc.

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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 APA Reagent	Assay method - rate nephelometry	Same as BeckmanImmunochemistry SystemsApolipoprotein A-1 Reagent
	Sample/reagent ratios
	Measuring Range:Initial 25 - 255 mg/dLExtended 25 - 450 mg/dL
	Antibody
DIFFERENCES
IMMAGE System APA Reagent	Reaction Temperature	IMMAGE System APA assayruns at 37°C and the predicateruns at 26.7°C.
	Reagent Container	IMMAGE reagent is stored in aplastic cartridge and thepredicate reagent is stored inglass vials.

Reagent	Aspect/Characteristic	Comments
SIMILARITIES
IMMAGE SystemAPB Reagent	Assay method - rate nephelometry	Same as BeckmanImmunochemistry SystemsApolipoprotein B Reagent
	Sample/reagent ratios
	Measuring Range:Initial 35 - 255 mg/dLExtended 35 - 450 mg/dL
	Antibody
DIFFERENCES
IMMAGE SystemAPB Reagent	Reaction Temperature	IMMAGE System APB assayruns at 37°C and the predicateruns at 26.7°C.
	Reagent Container	IMMAGE reagent is stored in aplastic cartridge and thepredicate reagent is stored inglass vials.

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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 companson, stability, and imprecision experiments that relate results obtained from the Beckman Immunochemistry Systems Apolipoprotein A-1 and B Reagents to the IMMAGE APA & APB Reagents.

Method Comparison Study Results IMMAGE APA & APB Reagents vs. Beckman Apolipoprotein A-1 and B Reagents

Analyte	Slope	Intercept	r	Predicate
IMMAGEAPA	0.998	1.86	0.983	BeckmanApolipoproteinA-1 Reagent onthe ARRAY
IMMAGEAPB	1.030	-1.34	0.991	BeckmanApolipoproteinB Reagent onthe ARRAY

Stability Study Results

Reagent	Product Claim
IMMAGE APA	24 months shelf-life14-day on board14 day calibration stability
IMMAGE APB	24 months shelf-life14 open container stability14 day calibration stability

Estimated Within-Run Imprecision

Material	MEAN(mg/dL)	SD(mg/dL)	%CV	Number ofResults
	APA Reagent
Level 1	56.7	3.12	5.5	80
Level 2	105	3.4	3.2	80
Level 3	167	4.8	2.9	80
	APB Reagent
Level 1	55.7	1.78	3.2	80
Level 2	115	2.9	2.5	80
Level 3	186	4.6	2.5	80

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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.

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Regulation Number and Section

§ 862.1475 Lipoprotein test system.

(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.