LogoFDA 510(k) Search
K Number
K042118
Device Name
ATHENA MULTI-LYTE EBV IGG TEST SYSTEM
Manufacturer
ZEUS SCIENTIFIC, INC.
Date Cleared
2005-04-29

(266 days)

Product Code
JRY
Regulation Number
866.3235
Type
Traditional
Panel
Microbiology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Zeus Scientific, Inc. AtheNA Multi-Lyte EBV IgG Test System is intended for the qualitative detection of IgG class antibody to three separate EBV Antigens (EBV-VCA gp-125, EBV-EA total and Recombinant EBNA-1) through the AtheNA Multi-Lyte System. The test system is intended to be used with these EBV IgG markers) along with anti-EBV VCA IgM to aid in the laboratory diagnosis of EBV-associated infectious mononucleosis and diseases caused by EBV virus.

Device Description

Not Found

AI/ML Overview

The provided text describes the regulatory clearance for the AtheNA Multi-Lyte® EBV IgG Test System but does not contain information about the acceptance criteria or a specific study proving the device meets those criteria.

Therefore, I cannot fulfill the request to provide:

  • A table of acceptance criteria and reported device performance.
  • Sample size used for the test set or data provenance.
  • Number of experts used to establish ground truth or their qualifications.
  • Adjudication method.
  • Multi-reader multi-case (MRMC) comparative effectiveness study details.
  • Standalone performance details.
  • Type of ground truth used.
  • Sample size for the training set.
  • How ground truth for the training set was established.

The document is a 510(k) clearance letter from the FDA, which confirms the device's substantial equivalence to a legally marketed predicate device. It specifies the "Indications for Use" but does not delve into the performance study details or acceptance criteria themselves. These details would typically be found in the 510(k) summary or the full submission, which is not provided here.

§ 866.3235 Epstein-Barr virus serological reagents.

(a)
Identification. Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).(b)
Classification. Class I (general controls).