N Latex B2-Microglobulin Reagent is an in vitro diagnostic reagent for the quantiative determination of human B2-microglobulin in serum by means of particle-enhanced nephelometry. Measurement of B2 -microblobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

Device Description

The N Latex Microglobulin Reagent intended to be used together with the Behring Nephelometer Systems in the quantitative determination of B2-microglobulin in serum. Polystyrene latex particles coated with specific antibodies to human B2-microglobulin are agglutinated when mixed with samples containing B2-microglobulin. The intensity of the resulting scattered light measured by the nephelometer is dependent upon the B2microglobulin content of the sample which is determined by reference to standards of known concentrations.

AI/ML Overview

This is a 510(k) summary for a medical device, specifically an in-vitro diagnostic reagent (N Latex B2-Microglobulin Reagent). The requested information primarily pertains to studies for AI/ML-based medical devices or diagnostic imaging devices, which have different evaluation criteria than an in-vitro diagnostic reagent.

Therefore, many of the requested fields (such as "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "Training set sample size," etc.) are not applicable in their typical sense for this type of submission.

However, I can extract the relevant performance characteristics as outlined in the provided text, which function as the "acceptance criteria" and "reported device performance" for this in-vitro diagnostic.

Here's the information extracted from the provided text, adapted to the closest applicable categories:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Typically implied by "Proposed Device Performance Characteristics")	Reported Device Performance (N Latex B2-Microglobulin Reagent)
Assay Range (Standard sample dilution 1:100)	Approx. 0.62 to 20 mg/l
Assay Range (Extended sample dilution 1:400)	Approx. 80 mg/l
Sensitivity	Given by the lower limit of the reference curve; depends on the ß2-microglobulin concentration of the standard. (Specific numeric value not provided as a fixed criterion, but rather a definition.)
Intra-assay Precision (Coefficient of Variation, n=20 replicates)	2.5% to 3.3% across three concentrations (approx. 1.2, 1.5, and 6.0 mg/l)
Inter-assay Precision (Coefficient of Variation, n=8 replicates)	2.1% to 3.0% across three concentrations (approx. 1.0, 1.4, and 5.8 mg/l)
Method Comparison (Correlation with a commercially available enzyme immunoassay)	Correlation Coefficient: 0.987Y-intercept: 0.215Slope: 0.967

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Method Comparison (Accuracy): 84 serum samples.
Provenance: Not specified (e.g., country of origin, retrospective/prospective).
Sample Size for Precision Studies:
- Intra-assay: 20 replicates for each of three concentrations.
- Inter-assay: 8 replicates for each of three concentrations.
- Provenance for precision: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable for an in-vitro diagnostic reagent. The "ground truth" for method comparison is the result from a legally marketed predicate device (Abbott IMx B2 Microglobulin) or a commercially available enzyme immunoassay.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for an in-vitro diagnostic reagent.

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

Not applicable. This is not an AI/ML device or an imaging device with human readers.

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

This device is a standalone diagnostic reagent – its performance is evaluated directly through chemical assays, not through an algorithm requiring human interaction for interpretation in the same way an AI/ML imaging device would. The performance metrics listed (assay range, precision, method comparison) represent its standalone analytical performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the method comparison (accuracy) study, the "ground truth" was established by comparison with a commercially available enzyme immunoassay. The goal was to show strong correlation, slope, and intercept relative to this established method.

8. The sample size for the training set

Not applicable in the context of an AI/ML training set. For an in-vitro diagnostic, "training" involves calibrating the instrument and establishing the standard curve using known concentrations of the analyte. The document states the sensitivity "depends on the B2-microglobulin concentration of the standard," implying a set of standards are used for calibration, but a specific "training set sample size" as an AI term is not relevant.

9. How the ground truth for the training set was established

Not applicable as an AI/ML training set. For this device, the "standards of known concentrations" (mentioned in the device description and assay range/sensitivity sections) are used to calibrate the nephelometer. The ground truth for these standards would be established through highly controlled laboratory methods, typically gravimetric or spectrophotometric, using purified B2-microglobulin.

Summary

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K955596

Behring Diagnostic Inc N Latex B2- Microglobulin Reagent 510(k) Notification

OCT - 3 199

Attachment 1

Summary of Safety and Effectiveness for 510(k) N Latex B2-Microglobulin Reagent

Manufactures Name, Address, Telephone, and contact person, date of 1 . preparation:

Manufacturer

Behringwerke AG Postfach 1140 35001 Marburg Germany

Distributor

Behring Diagnostics Inc. 151 University Avenue Westwood, MA 02090 617-320-3000 Attn: Kathleen Dray-Lyons

Preparation date: July 16, 1996

2 . Name/ Classification: Device

N Latex B2-Microblobulin Reagent for the quantitative determination of B2-Microglobulin Classification Number: class 11 (866.5630)

3 . Identification of the legally marketed device:

Abbott IMx B2 Microglobulin

4 . Proposed Device Description:

5 . Proposed Device Intended Use:

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Behring Diagnostic Inc N Latex B2- Microglobulin Reagent 510(k) Notification

Partistics and Carling

Medical device to which equivalence is claimed and comparison 6 . information:

The B2-Microglobulin assay using the proposed product is substantially equivalent in intended use and results obtained to the Abbott IMx B2 Microglobulin. The Abbott IMx B2 Microglobulin like the proposed product, depends upon assaying standards of known B2microglobulin content to convert the measured signal to concentrations. Both tests utilize specific antibody to B2-microglobulin for capture of the B2-microglobulin present in sample.

The N Latex B2-Microglobulin Reagent differs from the Abbott IMx B2 Microglobulin in that the Abbott IMx B2 Microglobulin assay is a sequential binding assay which consists of an antibody-antigen complex that is transfered to a glass fiber and measured using a fluorometer; while the N Latex B2-Microglobulin Reagent contains antibody that is affixed to a polystyrene particle which binds the B2-microglobulin in the patient sample. The polystyrene particles agglutinate, increasing the amount of light a given concentration of B2-microglobulin can scatter, effectively amplifying the signal when measure by a nepholometer.

7 . Proposed Device Performance Characteristics:

Assay range and sensitivity

The N Latex Bo-Microglobulin Reagent is designed to measure Bo-microglobulin concentrations within an assay range of approx. 0.62 to 20 mg/l for a sample dilution of 1:100. If a sample dilution of 1:400 is used the assay range is extended to approx. 8 0 mg/l.

The sensitivity is given by the lower limit of the reference curve and thus depends on the Bo-microglobulin concentration of the standard.

Precision and reproducibility

B2-microglobulin Intra-assay by assaying three precision was determined concentrations (approx. 1.2, 1.5 and 6.0 mg/l) in replicates of twenty (20), the coefficient of variation ranged from 2.5 to 3.3 %.

Inter-assay precision was determined by assaying three Bo-microglobulin concentrations (approx. 1.0, 1.4, and 5.8 mg/l) for a total of eight (8) replicates, the coefficient of variation ranged from 2.1 to 3.0%.

Method comparison (accuracy)

Results of comparative studies using the N Latex (S2-Microglobulin Reagent and a commercially available enzyme immunoassay for 84 serum samples gave a correlation coefficient of 0.987, a y-intercept of 0.215, and a slope of 0.967.

Regulation Number and Section

§ 866.5630

Beta -2-microglobulin immunological test system.(a)
Identification. Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesbeta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.