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K Number
K973882
Device Name
EL-B2GP1SCR
Manufacturer
THERATEST LABORATORIES, INC.
Date Cleared
1997-12-05

(52 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

The TheraTest EL-B2GP1scr is an in vitro diagnostic tests for the screening for autoantibodies in human serum directed against the serum glycoprotein ß 2 Glycoprotein 1 (ß2GP1) . This measurement aids in the diagnosis of antiphospholipid antibody syndrome (APS) or certain autoimmune thrombotic disorders such as those secondary to systemic lupus erythematosus.

Device Description

Not Found

AI/ML Overview

The provided document set contains a 510(k) premarket notification letter from the FDA to TheraTest Laboratories, Inc. regarding their EL-B2GP1 Scr device. This letter indicates the device is an in vitro diagnostic test for screening autoantibodies in human serum directed against the serum glycoprotein ß2 Glycoprotein 1 (ß2GP1) to aid in the diagnosis of antiphospholipid antibody syndrome (APS) or certain autoimmune thrombotic disorders.

However, the provided text does not contain any information about acceptance criteria, specific studies, sample sizes, expert qualifications, adjudication methods, or detailed performance data (like sensitivity, specificity, or accuracy) of the device.

The document is a clearance letter, not a study report. Therefore, I cannot fulfill your request for:

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

§ 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).