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K Number
K981029
Device Name
BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT
Manufacturer
THE BINDING SITE, LTD.
Date Cleared
1998-07-20

(123 days)

Product Code
MOB
Regulation Number
866.5660
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This assay is designed for the in-vitro masourement of specific IgG autoantibodies against proteinase 3 (PR3) present in human serum, as an aid in the diagnosis of Wegener's granulomatosis and certain forms of autoimmune vasculitis in conjunction with other clinical findings.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a device called "Bindazyme Anti-PR3 Enzyme Immunoassay Kit," which confirms that the device is substantially equivalent to legally marketed predicate devices.

The letter mentions the "Indications for Use Statement" where the device's purpose is described, but it does not detail specific acceptance criteria (like sensitivity, specificity, accuracy thresholds), nor does it provide information about a study proving these criteria were met. It primarily focuses on regulatory approval and compliance.

Therefore, I cannot provide:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set or data provenance.
  3. Number of experts or their qualifications for ground truth.
  4. Adjudication method.
  5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Information on a standalone algorithm performance study.
  7. The type of ground truth used.
  8. Sample size for the training set.
  9. How 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).