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K Number
K992440
Device Name
AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA
Manufacturer
COGENT DIAGNOTICS LTD.
Date Cleared
1999-09-21

(61 days)

Product Code
MID
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

Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to cardiolipin in human serum.

Uses:

The results of the anti-cardiolipin assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-cardiolipin antibodies including antiphospholipid syndrome.

Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.

The assay may be used on the Hycor Hy•Tec Automated EIA instrument.

For in vitro diagnostic use only.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a diagnostic device named Autostat™ II Anti-CARDIOLIPIN IgG ELISA. It confirms that the device is substantially equivalent to a legally marketed predicate device. However, this document does not contain the detailed information needed to answer the specific questions about acceptance criteria, study design, expert qualifications, or ground truth establishment.

A 510(k) clearance letter primarily focuses on regulatory aspects and substantial equivalence, not the detailed performance study data. To answer your questions, one would typically need access to the full 510(k) submission, which includes the summary of safety and effectiveness, or a separate publication of the performance study.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about the study that proves the device meets those criteria from the information given. The document does not contain:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes for test or training sets, nor data provenance.
  3. Information on the number or qualifications of experts used for ground truth.
  4. Adjudication methods.
  5. Information about MRMC comparative effectiveness studies.
  6. Details about standalone algorithm performance.
  7. The type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

The document does mention:

  • Device Trade Name: Autostat™ II Anti-CARDIOLIPIN IgG ELISA
  • Intended Use/Indications For Use: Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to cardiolipin in human serum. Used as an aid in the diagnosis of diseases associated with elevated levels of anti-cardiolipin antibodies including antiphospholipid syndrome.
  • Regulatory Class: II
  • Product Code: MID
  • Applicant: Cogent Diagnostics Limited
  • Device Type: In vitro diagnostic use only.

To get the information you are requesting, you would need to consult the original 510(k) submission documentation (specifically the "Summary of Safety and Effectiveness") which may be available through the FDA's databases, or any peer-reviewed publications that Cogent Diagnostics Limited might have produced regarding the validation of this specific assay.

§ 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).