LogoFDA 510(k) Search
K Number
K150412
Device Name
Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator
Manufacturer
The Binding Site Group Ltd
Date Cleared
2015-08-28

(191 days)

Product Code
DAE,JIX,JJY
Regulation Number
866.5240
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 CH50 reagents are intended for the quantitative in vitro determination of total classical complement activity (CH50) in human serum using the Binding Site Optilite turbidimetric analyser. Measurement of complement activity aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components. This test should be used in conjunction with other laboratory and clinical findings. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.

The Optilite CH50 calibrator is intended for use on the Optilite analyser in conjunction with the Binding Site Optilite CH50 Reagent (product code NK095.OPT) for the determination of total complement activity. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.

The Optilite CH50 controls are intended for use on the Optilite analyser in conjunction with the Binding Site Optilite CH50 Reagent (product code NK095.OPT) for the determination of total complement activity. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to complete the requested table and study description. The document is an FDA 510(k) clearance letter for the Optilite CH50 Reagent, Controls, and Calibrator, and it primarily focuses on the device's indications for use and regulatory compliance.

It does not include:

  • A table of specific acceptance criteria and reported device performance.
  • Details about sample sizes for test sets, data provenance, or training sets.
  • Information on the number or qualifications of experts for establishing ground truth, or adjudication methods.
  • Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.
  • The type of ground truth used.

Therefore, I cannot fulfill your request based on the provided input.

§ 866.5240 Complement components immunological test system.

(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(b)
Classification. Class II (performance standards).