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K Number
K983083
Device Name
QUANTA LITE RF IGG ELISA
Manufacturer
INOVA DIAGNOSTICS, INC.
Date Cleared
1998-11-04

(62 days)

Product Code
DHR
Regulation Number
866.5775
Type
Traditional
Panel
Immunology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

QUANTA Lite™ RF IgG ELISA is a semiquantitative enzyme-The linked immunosorbent assay (ELISA) for the detection of IgG rheumatoid factor (RF) antibodies in patient sera. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of rheumatoid arthritis (RA).

Device Description

QUANTA Lite™ RF IgG ELISA is a semiquantitative enzyme-The linked immunosorbent assay (ELISA)

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the QUANTA Lite™ RF IgG ELISA device. It declares the device substantially equivalent to a legally marketed predicate device for aiding in the diagnosis of rheumatoid arthritis.

However, the document does not contain the detailed information necessary to answer your request regarding acceptance criteria and the specifics of the study that proves the device meets those criteria, such as:

  • A table of acceptance criteria and reported device performance: This information is typically found in the scientific study report or the 510(k) submission's performance data section, not in the clearance letter itself.
  • Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, and how training ground truth was established. These are all specific details about the clinical or analytical validation studies, which are not included in this FDA clearance letter.

This document is a formal notification of market clearance based on the FDA's review of the applicant's submission. It confirms that the FDA found the device "substantially equivalent" to an existing product for the stated "Indications For Use," meaning the company provided data (in a separate submission) that supported this claim.

To answer your question, you would need to consult the actual 510(k) submission (K983083, though the enclosure references K982883) or the underlying study reports, which are not provided here.

§ 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).