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K Number
K012296
Device Name
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T
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. Subcrasses of these immunoglobulins aids in the diagnosis of reasurement of chobe inmancy-nd 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

This is a 510(k) summary, not a study report. Therefore, it does not contain the detailed information required to answer all the questions about acceptance criteria and study particulars. A 510(k) notification primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study report with acceptance criteria and performance data.

However, based on the provided text, I can extract the following limited information:

  • Device Name: Human IgG Subclass Liquid Reagent Kits (for use on the Behring BNII Analyser)
  • Intended Use: Quantifying IgG subclasses 1, 2, 3 and 4 immunoglobulins in serum on the BNII. Measurement aids in the diagnosis of primary and secondary immunodeficiency and the body's lack of ability to resist infectious agents.
  • Predicate Device: Not explicitly named, but the submission claims "substantial equivalence" to legally marketed predicate devices.

The document does not provide:

  • A table of acceptance criteria and reported device performance.
  • Sample size used for the test set or data provenance.
  • Number of experts or their qualifications for ground truth establishment.
  • Adjudication method.
  • Information on a multi-reader multi-case (MRMC) comparative, human-in-the-loop, or standalone performance study.
  • The type of ground truth used.
  • Sample size for the training set.
  • How the ground truth for the training set was established.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study details based on the provided text.

§ 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).