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K Number
K971335
Device Name
QUANTA LITE CMV IGG ELISA
Manufacturer
INOVA DIAGNOSTICS, INC.
Date Cleared
1997-12-01

(235 days)

Product Code
LFZ
Regulation Number
866.3175
Type
Traditional
Panel
Microbiology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The QUANTA Lite™ CMV IgG ELISA kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quanitative detection of IgG antibodies to cytomegalovirus (CMV) in human serum. This test is intended to be used to evaluate serologic evidence of previous or primary infection with CMV. This assay has not been FDA cleared or approved for the screening of blood or plasma donors.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a diagnostic device, the QUANTA Lite™ CMV IgG ELISA Test Kit. It does not contain the acceptance criteria, device performance details, or information about a study that proves the device meets acceptance criteria.

The letter primarily:

  • Acknowledges receipt and review of the 510(k) notification.
  • States that the device is substantially equivalent to legally marketed predicate devices.
  • Grants permission to market the device, subject to general controls.
  • Provides information about regulatory classifications, additional controls, and relevant regulations.
  • Instructs the applicant on how to determine CLIA complexity categorization.
  • Includes the "Indications For Use" for the device, which describes what the test is designed to do (detect IgG antibodies to CMV in human serum for evaluating previous or primary infection) and specifies what it is not approved for (screening blood/plasma donors).

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) from this document. The document is a regulatory approval, not a scientific study report or performance evaluation.

§ 866.3175 Cytomegalovirus serological reagents.

(a)
Identification. Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.(b)
Classification. Class II (performance standards).