FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The VZV IgG ELISA test system is and enzyme-linked immunosorbent assay (ELISA) designed for the manual or automated (Aptus), qualitative determination of IgG-class antibody to VZV in human serum. The test is intended to be used to aid in the determiation of immune status, and/or aid in the diagnosos of VZV infections, and is for in vitro diagnostic use.

Device Description

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AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the "Aptus (automated) Application for the VZV IgG ELISA Test System". This document grants clearance based on substantial equivalence to a predicate device and describes the intended use of the device, but it does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory clearance, not the specifics of the clinical study that would have supported the 510(k) submission.

To answer your questions, I would need access to the actual 510(k) submission document or a summary of the clinical study, which are not provided in the given text.

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K Number

K961012

Device Name

VZV IGG ELISA TEST SYSTEM

Manufacturer

ZEUS SCIENTIFIC, INC.

Date Cleared

1996-07-24

(133 days)

Product Code