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K Number
K984473
Device Name
LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205
Manufacturer
BIO-RAD
Date Cleared
1998-12-22

(6 days)

Product Code
LKJ
Regulation Number
866.5100
Type
Traditional
Panel
IM
Reference & Predicate Devices
K954723
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Liquichek ANA Control, EIA Screen is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the screening of antinuclear antibodies (ANA).

Device Description

Liquichek ANA Control, EIA Screen is prepared from human serum with added preservatives and stabilizers. This product is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for a quality control device (Liquichek ANA Control, EIA Screen) and focuses on demonstrating substantial equivalence to a predicate device.

Specifically, the document includes:

  • Intended Use: The device is for use as an unassayed quality control to monitor enzyme immunoassay procedures for the screening of antinuclear antibodies (ANA).
  • Comparison to Predicate Device: A table comparing the technical characteristics of the Bio-Rad Liquichek ANA Control, EIA Screen to the Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit. This comparison highlights similarities in form, matrix, storage, and general purpose.
  • FDA Clearance Letter: A letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.

However, it lacks the following information that would be necessary to answer the prompt:

  1. Acceptance Criteria and Reported Device Performance: No specific numerical or qualitative acceptance criteria are defined for the performance of the Bio-Rad device itself, nor are there any study results that report its performance against such criteria.
  2. Study Details: There is no description of any study (e.g., sample size, data provenance, ground truth establishment, expert involvement, adjudication methods, MRMC studies, or standalone performance studies). This is expected for a quality control device seeking 510(k) clearance, as the primary focus is often on demonstrating equivalence to an existing product rather than de novo performance validation against clinical endpoints.
  3. Training Set Information: Since no performance study is described, there is no information about training sets or how their ground truth would have been established.

In summary, based on the provided text, it is not possible to describe the acceptance criteria or a study that proves the device meets those criteria.

§ 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).