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 quartitative determination of Immunoglobulin G in urine by rate nephelometry.

Device Description

The IMMAGE Immunochemistry System Urine Immunoglobulin G (IGU) reagent, in coniunction with Beckman's Urine Protein Calibrator, is intended for use in the quantitative determination of Immunoglobulin G in human urine samples.

AI/ML Overview

This document describes the IMMAGE™ Immunochemistry System Urine Immunoglobulin G (IGU) Reagent. The acceptance criteria and supporting study are outlined below:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (IMMAGE IGU Reagent)
Method Comparison (vs. Predicate Device)
Slope should be close to 1.00	1.00
Intercept should be close to 0.00	0.00
Correlation coefficient (r) should be close to 1.00 (indicating strong linearity)	0.998
Stability
Shelf-life	24 months
Open container stability	14 days
Calibration stability	14 days
Within-Run Imprecision (as %CV)
For Level 1 material	10.2%
For Level 2 material	2.7%
For Level 3 material	2.7%

Study Details

1. Sample sized used for the test set and the data provenance:

Method Comparison Test Set Size: 115 samples.
Data Provenance: Not specified; the document does not mention the country of origin or if the data was retrospective or prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is an in-vitro diagnostic device measuring a biological analyte. The ground truth for method comparison is the measurement obtained from a predicate device, not expert consensus.

3. Adjudication method for the test set:

Not applicable. As this is a quantitative analytical device, adjudication by experts for ground truth is not relevant. The comparison is against a well-established predicate device.

4. 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:

Not applicable. This is an in-vitro diagnostic reagent, not an AI-assisted diagnostic tool that involves human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, this study represents a standalone performance evaluation of the IMMAGE IGU Reagent system. Its performance is compared to a predicate device, and its stability and imprecision are assessed independently. The "algorithm" here refers to the nephelometric methodology of the IMMAGE system.

6. The type of ground truth used:

Method Comparison: The ground truth for the method comparison study was established by measurements obtained from the Beckman Immunoglobulin G (IGG) Test System (Urine application), which is the predicate device.
Stability and Imprecision: The ground truth for stability and imprecision studies would be based on established analytical reference methods and quality control materials for immunoglobulin G measurements.

7. The sample size for the training set:

Not applicable. This document describes an in-vitro diagnostic reagent, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The development of such reagents relies on chemical and biological principles, not statistical learning from a dataset.

8. How the ground truth for the training set was established:

Not applicable, as there is no "training set" for this type of device.

Summary

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BECKMAN

MAR - 6 1997

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

Date Submitted: 2.0

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)

Predicate Device(s): 4.0

Beckman Immunoglobulin G (IGG) Test System (Urine application) K951635

5.0 Description:

6.0 Intended Use:

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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 SystemIGU Reagent	Analytic Range	Same asBeckman IGG Test Systemreagent
	Nephelometric methodology
	Antibody source (goat)
DIFFERENCES
IMMAGE SystemIGU Reagent	Antigen excess testing	IMMAGE IGU has antigenexcess testing solutionincluded in the reagentcartridge, while the BeckmanIGG Test System requires off-line preparation of thesolution.
	Antibody concentration	IMMAGE IGU has a higherantibody concentration thanthe Beckman IGG TestSystem

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Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Urine Immunoglobulin G (IGU) 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 companson, 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 IGUReagent	1.00	0.00	0.998	115	Beckman(IGG) TestSystem

Stability Study Results

Reagent	Product Claim
IMMAGE IGU	24 month shelf-life14 day open container stability14 day calibration stability

Estimated Within-Run Imprecision

MATERIAL			%CV	Number ofResults

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.

Regulation Number and Section

§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.

(a)
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.(b)
Classification. Class II (performance standards).