LogoFDA 510(k) Search
K Number
K032254
Device Name
IBL C1Q-CIC CIA TEST
Manufacturer
IBL GMBH
Date Cleared
2003-08-29

(38 days)

Product Code
DAK
Regulation Number
866.5240
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The IBL C1q-CIC test is a quantitative enzyme immunoassay for the in vitro diagnostic detection of circulating immune complex that bind C1q in human serum. The measurement is performed as an aid in the diagnosis of various autoimmune and other CIC related diseases. Levels of these complexes are one indicator in a multi-factorial diagnostic regime.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the "IBL C1q-CIC EIA Test". This document outlines the regulatory approval for an in vitro diagnostic device and does not contain the details of a study that describes acceptance criteria for device performance. It establishes that the device is substantially equivalent to legally marketed predicate devices, but doesn't provide specific performance metrics or the study design used to validate the device's accuracy.

Therefore,Based on the provided text, the following information cannot be extracted:

  • A table of acceptance criteria and the reported device performance: The document is a 510(k) clearance letter and does not include performance data or acceptance criteria.
  • Sample size used for the test set and the data provenance: Not available in this document.
  • Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
  • Adjudication method for the test set: Not available in this document.
  • If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not available in this document.
  • If a standalone performance (algorithm only without human-in-the-loop performance) was done: Not available in this document.
  • The type of ground truth used: Not available in this document.
  • The sample size for the training set: Not available in this document.
  • How the ground truth for the training set was established: Not available in this document.

The document states the "IBL C1q-CIC test is a quantitative enzyme immunoassay for the in vitro diagnostic detection of circulating immune complex that bind C1q in human serum. The measurement is performed as an aid in the diagnosis of various autoimmune and other CIC related diseases. Levels of these complexes are one indicator in a multi-factorial diagnostic regime." This is the device's intended use and contribution to diagnosis, but not its performance metrics.

§ 866.5240 Complement components immunological test system.

(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(b)
Classification. Class II (performance standards).