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K Number
K982485
Device Name
SERAQUEST CMV IGM
Manufacturer
QUEST INTL., INC.
Date Cleared
1999-01-13

(180 days)

Product Code
LFZ
Regulation Number
866.3175
Type
Traditional
Panel
MI
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • For the qualitative detection of IgM antibodies to CMV in human serum by enzyme immunoassay, to aid in the diagnosis of CMV infection.
  • A positive result is presumptive for the detection of anti-CMV antibodies and presumptive for the diagnosis of acute or recent CMV infection.
  • Useful for the above indications, with specimens obtained from women of childbearing age.
  • For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the SeraQuest CMV IgM device, which primarily concerns the substantial equivalence determination to a legally marketed predicate device.

The document discusses:

  • The FDA's review and determination of substantial equivalence for the SeraQuest CMV IgM device.
  • Regulatory classifications and general controls applicable to the device.
  • CLIA complexity categorization.
  • Contact information for various FDA offices.
  • The intended uses (indications for use) of the device.

There is no mention of specific performance metrics, acceptance criteria, study design, sample sizes, expert qualifications, ground truth establishment, or any comparative effectiveness studies as requested in your prompt.

§ 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).