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K Number
K100588
Device Name
HUMAN IGA2 KIT FOR USE ON THE SPAPLUS
Manufacturer
THE BINDING SITE GROUP LTD
Date Cleared
2010-08-16

(167 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 IgA Subclass 1 (IgA1) in serum using The Binding Site SPAPlus turbidimetric analyser. Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test result is to be used in conjunction with other clinical and laboratory findings.

This kit is intended for quantifying IgA Subclass 2 (IgA2) in serum using The Binding Site SPAPlus turbidimetric analyser. Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test result is to be used in conjunction with other clinical and laboratory findings.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA to The Binding Site Group, Ltd, for their Human IgA1 Kit and Human IgA2 Kit for use on the SPAPLUS™ turbidimetric analyser.

The letter confirms the substantial equivalence of the devices to legally marketed predicate devices and outlines general regulatory information and responsibilities. The "Indications for Use" attachments specify the intended use of the kits for quantifying IgA Subclass 1 and IgA Subclass 2 in serum to aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

However, there is no mention of:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes used for test sets or data provenance.
  • Number of experts or their qualifications for establishing ground truth.
  • Adjudication methods.
  • MRMC comparative effectiveness studies or effect sizes.
  • Standalone algorithm performance studies.
  • Type of ground truth used.
  • Sample size for the training set.
  • How ground truth for the training set was established.

Therefore, I cannot fulfill your request 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).