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K Number
K982622
Device Name
EL-ANA PROFILES: EL-ENA/5
Manufacturer
THERATEST LABORATORIES, INC.
Date Cleared
1998-08-13

(56 days)

Product Code
LLL
Regulation Number
866.5100
Type
Traditional
Panel
Immunology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The TheraTest EL-ANA Profiles: EL-ENA/5 is an in vitro diagnostic test for the screening of autoantibodies in human serum directed against the following extractable nuclear antigens: Sm, nRNP, SSA, SSB and Scl70. This screening aids in the diagnosis of systemic lupus erythematosus and related autoimmune disorders.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving device performance. The document is a 510(k) clearance letter from the FDA for a device called "EL-ANA Profiles: EL-ENA/5." It primarily focuses on the regulatory clearance for marketing the device based on substantial equivalence to a predicate device.

The letter does not include:

  • A table of acceptance criteria or reported device performance metrics.
  • Details about sample sizes for test or training sets.
  • Information on data provenance.
  • The number or qualifications of experts used for ground truth.
  • Adjudication methods.
  • Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
  • Whether a standalone algorithm performance study was conducted.
  • The type of ground truth used or how it was established for training data.

The relevant section for performance would typically be in the 510(k) submission itself, which is not provided here. The clearance letter only provides the "Indications for Use" and the determination of substantial equivalence.

§ 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).