The IMMAGE Immunochemistry System Alpha-1-Microglobulin (A1M) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Urine Protein Calibrator, is intended for the quantitative determination of of alpha-1-microglobulin in urine by rate nephelometry.

Device Description

The IMMAGE Immunochemistry System A1M Reagent in conjunction with Beckman Urine Protein Calibrator, is intended for use in the quantitative determination of alpha-1-Other Fotom Calibration is interesmples on Beckman's IMMAGE™ Immunochemistry System.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" with numerical targets in a formal table for the new device. Instead, it demonstrates substantial equivalence to a predicate device through various performance metrics. The implicit acceptance criteria are that the new device's performance should be comparable to or better than the predicate device.

Performance Metric	Implicit Acceptance Criteria (Comparable to Predicate)	Reported Device Performance (IMMAGE A1M Reagent)
Method Comparison
Slope (vs. Predicate)	Close to 1.0	0.961
Intercept (vs. Predicate)	Close to 0.0	0.10
Correlation Coefficient (r)	High (close to 1.0)	0.993
Stability	Maintenance of performance over specified durations
Shelf-Life	Comparable to predicate or acceptable for commercial use	12-month shelf-life
Open Container Stability	Acceptable for laboratory use	30-day open container stability
Calibration Stability	Acceptable for laboratory use	30-day calibration stability
Imprecision (Precision)	Acceptable within-run and total imprecision for a diagnostic device
Within-Run %C.V. (Level 1)	Low	2.8%
Within-Run %C.V. (Level 2)	Low	1.8%
Within-Run %C.V. (Level 3)	Low	2.4%
Total %C.V. (Level 1)	Low	4.1%
Total %C.V. (Level 2)	Low	2.0%
Total %C.V. (Level 3)	Low	2.9%

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

Sample Size for Method Comparison: 123 urine samples were used for the method comparison study.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) submission for a new device, it is highly likely that the data was collected prospectively in a controlled laboratory setting, but this is not explicitly stated.

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

This information is not applicable to this type of device and study. The IMMAGE A1M Reagent is a quantitative assay for alpha-1-microglobulin in urine. Ground truth for such assays is typically established by comparing results to a recognized reference method (in this case, the predicate Beckman Alpha-1-Microglobulin Reagent) or by using highly characterized samples with known concentrations. There are no "experts" in the sense of clinical reviewers establishing a diagnostic ground truth here, but rather a reference measurement system.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation of data (e.g., medical images) where multiple human readers contribute to establishing a consensus ground truth. For a quantitative chemical assay, the comparison is directly between the new device's numerical output and the predicate device's numerical output.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. This document describes a chemical reagent system, not an AI-powered diagnostic tool requiring human interpretation or an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is effectively a standalone performance study. The IMMAGE A1M Reagent, as a laboratory assay, generates quantitative results directly from the sample without human "interpretation" of its output that would significantly alter the result. The study evaluates the performance of the reagent system itself.

7. The Type of Ground Truth Used:

The "ground truth" for the method comparison study was established by the predicate method, the Beckman Alpha-1-Microglobulin Reagent on the Array® 360 System. This is a common approach in demonstrating substantial equivalence for in vitro diagnostic (IVD) devices: showing that the new device's results correlate highly with a legally marketed, previously cleared device.

8. The Sample Size for the Training Set:

This information is not applicable as this describes a chemical reagent system, not a machine learning or AI-based device that requires a training set. The "training" for such a system involves the chemical formulation of the reagent and the instrument's calibration procedures.

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

This information is not applicable for the same reasons as #8.

Summary

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BECKMAN

APR 21 1997

K965033 Summary of Safety & Effectiveness

IMMAGE™ Immunochemistry System Alpha-1-Microglobulin (A1M) 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:

16 December 1996

Device Name(s): 3.0

3.1 Proprietary Names

IMMAGE™ Immunochemistry System Alpha-1-Microglobulin (A1M) Reagent

Classification Name 3.2

Not classified

Predicate Device(s): 4.0

IMMAGE SystemReagent	Predicate	Manufacturer	DocketNumber
IMMAGE SystemAlpha-1-Microglobulin(A1M) Reagent	Beckman Alpha-1-Microglobulin A1MReagent	Beckman Instruments,Inc.	K933078

Beckman Instruments, Inc.

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Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Alpha-1-Microglobulin (A1M) Reagent Summary of Safety & Effectiveness

5.0 Description:

Intended Use: 6.0

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 System A1M Reagent	Analytic Range	Same as Beckman Alpha-1-Microglobulin Reagent
IMMAGE System A1M Reagent	Nephelometric methodology
IMMAGE System A1M Reagent	Antibody source (goat)
DIFFERENCES
IMMAGE System A1M Reagent	Antigen excess testing	IMMAGE A1M has antigen excess testing solution included in the reagent cartridge, while the Beckman Alpha-1-Microglobulin Reagent requires off-line preparation of the solution.
IMMAGE System A1M Reagent	Antibody concentration	IMMAGE A1M has a higher antibody concentration than the Beckman Alpha-1-Microglobulin Reagent

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Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Alpha-1-Microglobulin (A1M) 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 Beckman Reagent on the Array® 360 System to the IMMAGE System Reagent.

Method Comparison Study Results IMMAGE Alpha-1-Microglobulin (A1M) Reagent

Analyte	Sample Type	Slope	Intercept	r	n	Predicate Method
IMMAGEA1MReagent	Urine	0.961	0.10	0.993	123	BeckmanAlpha-1-MicroglobulinReagent

Stability Study Results

Reagent Career State	coduct ClaimState of the state of the state of the state of the states of the states of the states of the states of the states of the states of the states of the states of the state of t
IMMAGE	month shelf-life
	day open container stability
	day calibration stability

Estimated Imprecision

Sample	Mean (mg/dL)	S.D. (mg/dL)	%C.V.	N
Within-Run Imprecision
Level 1	0.77	0.021	2.8	80
Level 2	3.05	0.056	1.8	80
Level 3	6.59	0.161	2.4	80
Total Imprecision
Level 1	0.77	0.031	4.1	80
Level 2	3.05	0.061	2.0	80
Level 3	6.59	0.194	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.

Regulation Number and Section

§ 866.5400

Alpha -globulin immunological test system.(a)
Identification. Analpha- globulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha- globulin (a serum protein) in serum and other body fluids. Measurement ofalpha- globulin may aid in the diagnosis of inflammatory lesions, infections, severe burns, and a variety of other conditions.(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 § 866.9.