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Architect Core-M Reagent Kit, Alinity i Anti-HBc IgM

by Abbott Laboratories 510(k)PMA

Active United States

PMA P060035510(k) K983132

Overview

The Architect Core-M Reagent Kit is a chemiluminescent microparticle immunoassay (CMIA) designed for the qualitative detection of IgM antibody to hepatitis B core antigen (IgM anti-HBc) in human serum or plasma. This assay aids in diagnosing acute or recent hepatitis B virus (HBV) infection when used alongside other laboratory results and clinical information. The device is intended for adult, pediatric, and neonatal samples, including those collected with dipotassium EDTA, lithium heparin, or sodium heparin.

The kit is supplied as a reagent system for use on the Architect i system, accompanied by calibrators and controls for system calibration and performance monitoring. It is intended for single-use and requires no special sterility measures beyond standard laboratory handling. The device is classified under FDA’s Class II regulatory framework, with approvals granted via 510(k) and PMA pathways. No MRI safety considerations apply, and storage conditions are specified in the accompanying documentation.

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

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMA PMA NumberP060035 Date6 Nov 2007ApprovedStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK983132 Date4 Nov 1998ClearedStatusActive

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 510(k), FDA PMA Active

Recalls

2 recalls · FDA

    • Terminated Z-1990-2019 FDA Class II initiated 16 May 2018

    An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.

    • Terminated Z-0384-06 FDA Unclassified (pre-2012) initiated 10 Nov 2005

    These specific protein assays are not meeting the 57-day on board stability claim

Specification

510(k) · PMA

Full name
ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit
Trade Name
Architect Core-M Reagent Kit/Calibrators/Controls
Generic Name
Qualitative and Quantitative Hepatitis B Virus Antibody assays
PMA Number
510(k) Number
FDA Product Code
DFT
Device Class
Class II
Regulation
21 CFR Part 866.5550
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the purpose of the Architect Core-M Reagent Kit?

    The kit is a chemiluminescent microparticle immunoassay (CMIA) designed for the qualitative detection of IgM antibody to hepatitis B core antigen in human serum or plasma, aiding in diagnosing acute or recent HBV infection when used with other laboratory results and clinical information.

  • What sample types can be used with this reagent kit?

    The device is intended for adult, pediatric, and neonatal samples, including those collected with dipotassium EDTA, lithium heparin, or sodium heparin.

  • Is the Architect Core-M Reagent Kit single-use or reusable?

    The kit is intended for single-use and requires no special sterility measures beyond standard laboratory handling.

  • What is included in the kit supply?

    The kit is supplied as a reagent system for use on the Architect i system, accompanied by calibrators and controls for system calibration and performance monitoring.

  • What are the storage conditions for this device?

    Storage conditions are specified in the accompanying documentation, though the exact details are not provided in the device data.