A latex agglutination assay intended for the quantitative turbidimetric detection of Rheumatoid IgM antibodies in human serum and plasma. When used according to instructions, the assay is useful in establishing the presence of rheurmatoid factor and as an aid in the diagnosis and management of rheumatoid arthritis.

Device Description

Raichem's Rheumatoid Factor SPIA ™ latex agglutination assay is a quantitative turbidimetric assay for the detection of Rheumatoid Factor IgM antibodies in human serum and plasma. In this assay, latex microspheres coated with human and rabbit IgG are diluted in a medium, usually, designed to allow aggregation without rapid settling of Rheumatoid Factor complexed microparticles. As aggregates form, the suspension becomes less cloudy, resulting in less light being absorbed. The change in optical density is proportional to the amount of RF present in the suspension. A quantitative determination of the amount of RF present in a serum/plasma sample is made by comparison to a standard curve.

AI/ML Overview

This document describes a diagnostic device, the Raichem's Rheumatoid Factor SPIA™ latex agglutination assay, for detecting Rheumatoid Factor IgM antibodies.

Here's an analysis of the provided text with respect to your requested information:

1. Table of Acceptance Criteria & Reported Device Performance

The document does not explicitly state "acceptance criteria" as pass/fail thresholds for performance metrics. However, it presents
the performance of the proposed device in comparison to a predicate device and an automated method. We can infer that the reported percentages and confidence intervals for sensitivity and specificity are intended to demonstrate acceptable performance.

Metric	Acceptance Criteria (Implied)	Reported Device Performance
Relative Analytical Sensitivity	High correlation with predicate	95.4% (0.95 CI: 90.8% to 97.8%)
Relative Analytical Specificity	High correlation with predicate	100% (0.95 CI: 98.0% to 100%)
Inter-assay Precision (%CV)	(Not explicitly stated)	Range: 5.3% - 20.7% (for Mean IU/mL)
Intra-assay Precision (%CV)	(Not explicitly stated)	Range: 5.4% - 11.5% (for Mean IU/mL)

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

Test Set Sample Size: 335 serum specimens (for the comparison study with the predicate device and automated method).
Data Provenance: The data comes from "serum specimens from rheumatoid arthritis patients, patients with autoimmune diseases, and normal apparently healthy donors." The country of origin is not specified, but the context implies it is a clinical study. The data appears to be retrospective as it involves existing banked or collected specimens.

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

The document mentions "The discrepant and equivocal samples were evaluated by a third party EIA method." This implies that a reference method (EIA) was used to resolve discrepancies and establish a final ground truth for specific cases. However, it does not specify the number of experts or their qualifications. It's likely that the "third party EIA method" itself is considered the expert or reference standard, rather than a human expert.

4. Adjudication Method for the Test Set

The adjudication method is described as: "The discrepant and equivocal samples were evaluated by a third party EIA method." This suggests a method where discrepant results (between the proposed device and the predicate) and equivocal results (from the predicate device) were adjudicated by a recognized reference assay. This is a form of third-party adjudication by a reference method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a quantitative turbidimetric assay, not an imaging device or one that relies on human interpretation in the same way an MRMC study would assess. Its performance is measured directly against a predicate device and automated systems, not human readers with and without AI assistance.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Yes, the performance data provided appears to be for the standalone (algorithm only) performance of the Raichem's Rheumatoid Factor SPIA™ assay. The assay is described as a "quantitative turbidimetric assay" which, while designed to be adaptable to automated systems like the COBAS-MIRA, fundamentally operates based on a direct measurement of optical density change. The precision and comparison studies detail the analytical performance of the assay itself, not its performance when interpreted by a human in a loop.

7. Type of Ground Truth Used

The primary ground truth appears to be based on results from a predicate device (Hemagen® RF Kit (HA method)) and a third-party EIA method used for resolving discrepancies. In essence, it's a reference standard comparison. The predicate device itself acts as a clinical reference. Additionally, the calibrator verification mentions comparison to the World Health Organization International Reference Preparation of Rheumatoid Arthritis Serum, which serves as a highly reliable reference for calibrator accuracy.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" sample size. This is typical for in vitro diagnostic (IVD) assays like this one, which are often developed using established biochemical principles and then validated on independent test sets (as described in section 2). The development of the assay itself, including optimization of reagents and protocols, would involve internal testing, but a formal "training set" in the machine learning sense is not applicable or reported here.

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

As no explicit "training set" is mentioned, the method for establishing its ground truth is not applicable/not provided in this summary. The ground truth for the validation/test set was established through comparison with a predicate device and adjudication by a third-party EIA method.

Summary

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K970373
April 17, 1997

PAGE 1

510(k) Summary

11:52:40 18:35:40 1

Joseph M. Califano Manager, Regulatory Affairs

Address

Hemagen Diagnostics, Inc.
34-40 Bear Hill Road Waltham, MA, 02154

(617) 890-3766 Phone: (617) 890-3748 Fax:

Date Prepared

30 Jan 1997

2. Device Name

Trade Name: Common Name: Classification Name: Rheumatoid Factor SPIA TM RF (Rheumatoid Factor) System, Test, Rheumatoid Factor

3. Predicate Device

Hemagen ® RF Kit (HA method) {510 (k) Docket No. K 855221/A}

Methods 3a.

Described in Laboratory Diagnostic Procedures in the Rheumatic . Manual: Diseases, 3d Ed. (1985) Chep. 4 Rhoumatoid Factors, Techniques of Analysis by McDuffle, F.C.
II. Automated System: COBAS-MIRA Analyzer. {510 (k) Docket No. k 851172)
III. Third Party Test: Hemagen ® RF Kit (EIA method) {510 {k} Docket No. K 962386}

4. Description of Device

Raichern's Rheumatoid Factor SPIA ™ latex agglutination assay is a quantitative lught lidimet assay for the detection of Rheumatoid Factor IgM antibodies in human serum and pla

510 (k) Summary Page 1

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4. Description of Device

Raichem's Rheumatoid Factor SPIA ™ latex agglutination assay is a quantitative turbidimetric assay for the detection of Rheumatoid Factor IgM antibodies in human serum and plasma.

In this assay, latex microspheres coated with human and rabbit IgG are diluted in a m the usually, clesigned to allow aggregation without rapid settling of Rheumatoid Factor complexed microparticles. As aggregates form, the suspension becomes less cloudy, resulting in less light being absorbed. The change in optical density is proportional to the amount of RF present in the suspension.

A quantitative determination of the amount of RF present in a serum/plasma sample is made by comparison to a standard curve.

5. Intended Use of Device

6.(A) Technological Characteristics

Proposed Device

Raichem's Rheumatoid Factor SPIA™ latex agglutination assay is a quantitative turbidimetric assay. The amount of RF present is proportional to the change in optical density in the suspension. The RF IgM antibody concentration is quantified by comparison to a standard curve. This assay is performed manually following clinically accepted methodologies. The assay is designed to enable users to readily adapt it for use with automated systems such as the Roche COBAS MIRA Analyzer.

Predicate Device

The Hemagen ® RF(HA) Kit is a hemagglutination based assay. The device utilizes the method of agglutination of specifically sensitized human erythrocytes by patient servim containing rheumatoid factor. The resultant level of agglutination is used to determine the presence or absence of rheumatoid factor.

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6.(B) Performance Data

Precision l.

ﻨﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

ﺘﻪ .. ..

To evaluate precision, inter-assay and intra-assay studies were conducted with the To evaluate proclaision more on an automated system {COBAS-MIRA}

A. Inter-assay reproducibility

Six different serum samples were assayed twice a day on four different days.

SAMPLE	Mean IU/mL	Std. Dev	% CV	Mean Delta	Std. Dev	% CV
1	95.4	5.0	5.3	0.111	0.007	6.4
2	80.3	5.3	6.6	0.097	0.007	7.7
3	67.9	9.9	14.6	0.087	0.010	11.8
4	45.9	9.5	20.7	0.071	0.010	13.8
5	< 20	N/A	N/A	0.037	0.003	9.4
6	< 20	N/A	N/A	0.036	0.005	15.0

B. Intra-assay reproducibility

Six different serum samples were assayed 20 consecutive times in a single run.

SAMPLE	Mean IU/mL	Std. Dev	% CV	Mean Delta	Std. Dev	% CV
1	56	3.7	6.7	0.080	0.004	5.4
2	48	3.2	6.6	0.070	0.004	5.3
3	28	2.8	10.0	0.047	0.003	7.1
4	23	2.7	11.5	0.041	0.004	9.6
5	< 20	N/A	N/A	0.015	0.005	31.4
6	< 20	N/A	N/A	0.011	0.003	31.5

II. Verification of the RF Calibrator

The RF Calibrator(120 IU/mL} supplied with the assay is the same as the High Calibrator supplied with the Homagen @ Rhoumatoid Factor Kit (EIA method) (Refer to 510 (k) Docket No. 962386). The kit callbrators were compared to the World Health Organization International Reference Preparation of Rheumatoid Arthritis Serum. It was demonstrated that there is a high degree of correlation that exists between the kit calibrators and the W.H.O. Standard.

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Comparison Testing HIL.

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ن ا

lli. The Raichem Rheumatoid Factor SPIA ™ and the Hemlagene in "Nonbaggious"
Kit were used to assay serum specimens from theumatoid arthrits patients. Kit were used to assay serum specimens from medinated and the list.
with autoimmune diseases, and normal apparently healthy donors.

streetse age

0 P

Comparison with an automated method {COBAS-MIRA} A.

Table 1.1 Disease State Specimens (combined) n =335

	Predicate DevicePositive	Negative	Equivocal	Total
Proposed DevicePositive	141	31	0	144
Negative	91 *	180	21 *	191
Total	150	183	2	335

The discrepant and equivocal samples were evaluated by a third party EIA method

	EIA
	Positive	Negative
Proposed Device
Positive	3	0
Negative	7	4

Table 1.2_Disease State Specimens (combined). n =335

	Predicate Device
	Positive	Negative	Total
Proposed DevicePositive	144	0	144
Negative	7	184	191
Total	151	184	335
Relative analytical sensitivity = 95.4 % {144/151}, 0.95 INTERVAL = 90.8 % to 97.8 %
Relative analytical specificity = 100 % {184/184}, 0.95 INTERVAL = 98.0 % to 100 %

510(k) Summary Page 4

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).