AUTOSTAT II ANTI-SS-B/LA ELISA

• K Number: K990626
• Device Name: AUTOSTAT II ANTI-SS-B/LA ELISA
• Manufacturer: COGENT DIAGNOTICS LTD.
• Date Cleared: 1999-04-28 ( 62 days)
• Product Code: LLL
• Regulation Number: 866.5100
• Type: Traditional
• Panel: IM
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to SS-B in human serum.

Uses:

The results of the anti-SS-B/La assay can be used as an aid in the diagnosis of auto-immune diseases including Systemic Lupus Erythematosus (SLE) and Sjögren's Syndrome (SS).

For in vitro diagnostic use only.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for a medical device called Autostat™ II Anti-SS-B/La ELISA. It does not contain the detailed study results, acceptance criteria, or performance data that would allow me to fully answer your request.

The letter confirms that the device is substantially equivalent to a legally marketed predicate device for the purpose of semi-quantitative determination of specific IgG autoantibodies to SS-B in human serum, as an aid in diagnosing autoimmune diseases such as Systemic Lupus Erythematosus (SLE) and Sjögren's Syndrome (SS).

To answer your questions, I would need access to the actual 510(k) submission document or a summary of its data, which is not provided in this extract. The provided text is purely the FDA's clearance notice.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used or their qualifications.
4. Adjudication method.
5. Information about an MRMC comparative effectiveness study or effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Regulation Number and Section

§ 866.5100 Antinuclear antibody immunological test system.

(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).