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K Number
K983801
Device Name
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO
Manufacturer
ZEUS SCIENTIFIC, INC.
Date Cleared
1998-12-10

(43 days)

Product Code
LSE
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 test system is an enzyme-linked immunosorbent assay designed for the manual or automated (Aptus) qualitative detection of IgM class antibodies to EBV-VCA in human serum. The test system is intended to be used for the diagnosis of EBV-associated infectious mononucleosis (IM) when used in conjunction with other EBV serologies.

Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for the Aptus (automated) Application for the EBV-VCA IgM ELISA Test System (K983801). It primarily addresses regulatory aspects and does not directly contain acceptance criteria or study details in the format requested.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not available in the provided text.

However, I can extract the following limited information:

1. Device Name and Intended Use:

  • Device Name: Aptus (automated) Application for the EBV-VCA IgM ELISA Test System
  • Indications for Use: "The test system is an enzyme-linked immunosorbent assay designed for the manual or automated (Aptus) qualitative detection of IgM class antibodies to EBV-VCA in human serum. The test system is intended to be used for the diagnosis of EBV-associated infectious mononucleosis (IM) when used in conjunction with other EBV serologies."

Summary of unavailable information from the provided text:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes used for the test set and data provenance.
  • Number of experts used to establish ground truth for the test set and their qualifications.
  • Adjudication method for the test set.
  • Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
  • Information on a standalone (algorithm only) performance study.
  • Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
  • Sample size for the training set.
  • How the ground truth for the training set was established.

This document is solely an FDA clearance letter confirming substantial equivalence to a predicate device, not a detailed technical report of the validation study. Such details would typically be found in the 510(k) submission itself or associated technical documentation, 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).