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Architect HBSAG Qualitative/HBSAG Qualitative Confirmatory

by Abbott Laboratories PMA

Active United States

PMA P110029

Overview

The Architect HBSAG Qualitative/HBSAG Qualitative Confirmatory is a chemiluminescent microparticle immunoassay (CMIA) designed for the qualitative detection and confirmatory testing of Hepatitis B surface antigen (HBSAG) in human serum, plasma, and neonate serum. It is intended for use in identifying individuals with presumptive evidence of Hepatitis B virus (HBV) infection, including those with symptoms of hepatitis or at risk for HBV exposure, though it does not determine the state of infection or associated disease.

This assay is performed on the Architect system and is supplied as a reagent kit for laboratory use. It is not intended for blood, plasma, or tissue donor screening. The device operates in microbiology settings and requires adherence to standard laboratory protocols for handling infectious materials. Authorized under FDA PMA (P110029), it is classified as a Class II medical device under the Federal Food, Drug, and Cosmetic Act.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPRL NumberP110029 Date12 Apr 2012DecidedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA PMA Active

Recalls

1 recall · FDA

    • Terminated Z-0987-2013 FDA Class II initiated 18 Dec 2012

    Abbott has identified that assay files for the ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory assays (LNs 4P53 and 4P54) on the ARCHITECT i1000SR System were mistakenly made available on abbottdiagnostics.com in October 2012. Additionally, some i1000SR customers received notification through AbbottLink in November 2012 that assay files for LNs 4P53 and 4P54 were available. The AR

Specification

PMA

Trade Name
Architect Hbsag Qualitative, Qualitative Confirmatory, Confirmatory Manual Diluent, Calibrators, and Controls
Generic Name
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
PMA Number
FDA Product Code
LOM
Device Class
Class II
Regulation
21 CFR Part 866.3172
Advisory Committee
Microbiology
FDA Decision
APRL

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