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K Number
K120889
Device Name
AESKUSLIDES ANA HEP-2
Manufacturer
AESKU DIAGNOSTICS
Date Cleared
2012-10-15

(206 days)

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

AESKUSLIDES ANA-HEp-2 is an indirect fluorescent antibody assay utilizing HEp-2 tissue culture cells as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum. AESKUSLIDES ANA-HEp-2 Test System is intended for use as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain detailed information about acceptance criteria, study design, or device performance metrics for the AESKUSLIDES ANA-HEp-2. The document is primarily an FDA clearance letter and an "Indications for Use Form," which state the device's purpose and regulatory classification but do not elaborate on the specific studies conducted to demonstrate its performance relative to acceptance criteria.

Therefore, I cannot provide the requested information, including:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes used for test sets or their data provenance.
  • Number and qualifications of experts for ground truth establishment.
  • Adjudication methods.
  • Information on Multi-Reader Multi-Case (MRMC) studies or effect sizes.
  • Details on standalone algorithm performance.
  • Type of ground truth used.
  • Sample size for the training set.
  • How ground truth for the training set was established.

This type of information is usually found in the 510(k) summary or the full 510(k) submission, which is not provided in the given text.

§ 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).