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K Number
K980230
Device Name
QUANTA LITE B2 GPI SCREEN
Manufacturer
INOVA DIAGNOSTICS, INC.
Date Cleared
1998-03-24

(61 days)

Product Code
MSV
Regulation Number
866.5660
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

A qualitative enzyme linked immunoassay for the detection of IgG, IgM and IgA antibodies to β, glycoprotein I (β, GPI). β, GPI antibodies are used as an aid in the diagnosis of certain autoimmune thrombotic disorders, such as those secondary to systemic lupus erythematosus (SLE) or other lupus-like disorders.

Device Description

A qualitative enzyme linked immunoassay

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding a study that proves the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device called "QUANTA Lite™ Beta 2 GPI Screen ELISA".

This letter primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It mentions the general controls provisions of the Act and other regulatory information, but it does not include a description of the device's acceptance criteria, a performance study, or the specific details about sample sizes, ground truth establishment, or expert qualifications that you requested.

Therefore, I cannot extract the following information from the provided text:

  1. A table of acceptance criteria and the reported device performance
  2. Sample sized used for the test set and the data provenance
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
  4. Adjudication method for the test set
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
  6. If 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

The document is a regulatory approval, not a scientific study report.

§ 866.5660 Multiple autoantibodies immunological test system.

(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).