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K Number
K142735
Device Name
The Optilite IgG3 kit
Manufacturer
THE BINDING SITE GROUP LTD
Date Cleared
2014-12-21

(89 days)

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

The Optilite IgG3 Kit is intended for the quantitative in vitro measurement of IgG3 in serum using the Binding Site Optilite analyser. Measurement of this immunoglobulin is an aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test result should be used in conjunction with other laboratory and clinical findings.

Device Description

Not Found

AI/ML Overview

I'm sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them in the format requested. The document is a 510(k) clearance letter from the FDA for a device called "Optilite® IgG3 Kit," outlining its approval and general regulatory compliance. It does not include performance data, study design, sample sizes, expert qualifications, or ground truth establishment.

Specifically, the document contains:

  • Device Name: Optilite® IgG3 Kit
  • Intended Use: Quantitative in vitro measurement of IgG3 in serum using the Binding Site Optilite analyser. Aid in the diagnosis of abnormal protein metabolism and resistance to infectious agents.
  • Regulatory Information: 510(k) number, regulation number, product code, regulatory class.
  • FDA Clearance Statement: Confirmation of substantial equivalence to a predicate device.
  • General Controls Information: Reminders about registration, listing, GMP, labeling, etc.

It does not include:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes for test or training sets.
  • Data provenance.
  • Number of experts or their qualifications for ground truth.
  • Adjudication methods.
  • Information on MRMC comparative effectiveness studies.
  • Information on standalone algorithm performance.
  • Details on the type of ground truth used or how it 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).