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K Number
K991820
Device Name
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI
Manufacturer
ZEUS SCIENTIFIC, INC.
Date Cleared
1999-08-12

(77 days)

Product Code
LYR
Regulation Number
866.3110
Type
Traditional
Panel
MI
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Zeus Scientific, Inc., Helicobacter pylori IgG ELISA Test System is an enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to Helicobacter pylori in symptomatic adults 18 years or older. The test system is for in vitro diagnostic use.

Device Description

enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to Helicobacter pylori

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria, study design, and results. The document is an FDA 510(k) clearance letter for a "Helicobacter pylori IgG ELISA Test System," which indicates that the device has been found substantially equivalent to a predicate device.

However, it does not include:

  • A table of acceptance criteria and reported device performance.
  • Details about sample sizes for test or training sets.
  • Information on data provenance.
  • The number or qualifications of experts used for ground truth.
  • The adjudication method.
  • Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
  • Results from a standalone performance study.
  • The type of ground truth used.
  • How ground truth was established for the training set.

This document is primarily concerned with the regulatory clearance of the device rather than the specific details of its validation study and performance metrics.

§ 866.3110

Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).