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K Number
K051484
Device Name
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM.
Manufacturer
ZEUS SCIENTIFIC, INC.
Date Cleared
2005-12-05

(182 days)

Product Code
LFY
Regulation Number
866.3900
Type
Traditional
Panel
MI
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Zeus Scientific, Inc. AtheNA Multi-Lyte® VZV IgG Test System is a microparticle-based immunoassay intended for the quantitative determination of IgG class antibodies to Varicella-Zoster Virus in human serum. The AtheNA Multi-Lyte® VZV IgG Test System is intended for the qualitative determination of a previous infection with Varicella-Zoster Virus.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed study information required to fulfill your request. The document is an FDA 510(k) clearance letter for a medical device (AtheNA Multi-Lyte® VZV IgG Test System), which indicates that the device has been found substantially equivalent to a legally marketed predicate device.

While it mentions the "Indications For Use" and the type of immunoassay, it does not include:

  • A table of specific acceptance criteria.
  • Reported device performance metrics (sensitivity, specificity, accuracy, etc.) against those criteria.
  • Details about the study design that would prove the device meets acceptance criteria (e.g., sample sizes for test sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for test/training sets, or training set sample sizes).

Such details are typically found in the 510(k) submission itself or in separate clinical study reports, which are not part of this clearance letter.

§ 866.3900 Varicella-zoster virus serological reagents.

(a)
Identification. Varicella-zoster virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to varicella-zoster in serum. The identification aids in the diagnosis of diseases caused by varicella-zoster viruses and provides epidemiological information on these diseases. Varicella (chicken pox) is a mild, highly infectious disease, chiefly of children. Zoster (shingles) is the recurrent form of the disease, occurring in adults who were previously infected with varicella-zoster viruses. Zoster is the response (characterized by a rash) of the partially immune host to a reactivation of varicella viruses present in latent form in the patient's body.(b)
Classification. Class II (performance standards).