LogoFDA 510(k) Search
K Number
K081827
Device Name
HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS
Manufacturer
THE BINDING SITE, LTD.
Date Cleared
2008-12-19

(175 days)

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

This kit is intended for the quantitative in vitro determination of human IgA in serum, lithium heparin or EDTA plasma, using the Binding Site SPAPIJS turbidimetric analyser. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test results are to be used in conjunction with other clinical and laboratory findings.

Device Description

Human IgA liquid reagent kit for use on SPAPLUS™

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a diagnostic device, the "Human IgA Liquid Reagent Kit for use on SPAPLUS™". This type of document declares a device substantially equivalent to a predicate device, allowing it to be marketed.

However, the provided text does not contain the detailed study information required to fill out the table and answer all the questions about acceptance criteria and device performance. Specifically, the document is a regulatory approval letter and does not include:

  • A table of acceptance criteria or reported device performance.
  • Information about sample sizes for test or training sets.
  • Details on data provenance.
  • The number or qualifications of experts used for ground truth establishment.
  • Adjudication methods.
  • Results of multi-reader multi-case (MRMC) comparative effectiveness studies.
  • Information on standalone algorithm performance.
  • The type of ground truth used.
  • How ground truth was established for training data.

Therefore, I cannot fulfill the request using only the provided input. This document simply states that the FDA has reviewed the device and determined it is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It does not elaborate on the specific performance studies that underpinned this determination.

§ 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).