LogoFDA 510(k) Search
K Number
K012292
Device Name
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB
Manufacturer
THE BINDING SITE, LTD.
Date Cleared
2001-08-31

(42 days)

Product Code
CFN
Regulation Number
866.5510
Type
Traditional
Panel
Immunology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This kit is intended for quantifying IgG subclasses 1, 2, 3 and 4 immunoglobulins in serum on the BNII. Measurement of these immunoglobulins aids in the diagnosis of abnormal immunoglobulin production and the body's lack of ability to resist infectious agents.

Device Description

Human IgG Subclass Liquid Reagent Kits (for use on the Behring BNII Analyser)

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 the acceptance criteria. The text is a letter from the FDA regarding a 510(k) premarket notification for "Human IgG Subclass Liquid Reagent Kits," approving the device for marketing. It discusses regulatory information, classifications, and general controls, but it does not detail:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method.
  5. MRMC comparative effectiveness study results (effect size with AI assistance).
  6. Standalone algorithm performance.
  7. Type of ground truth used (pathology, outcomes data, etc.).
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

The "Indications for Use Statement" mentions that the kit is for "quantifying IgG subclasses 1, 2, 3 and 4 immunoglobulins in serum," and that "Measurement of these immunoglobulins aids in the diagnosis of primary and secondary immunodeficiency diseases and the body's lack of ability to resist infectious agents." However, this is about the intended use, not the performance or validation study details.

§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.

(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).