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ARCHITECT Free PSA Reagent Kit, Alinity i Free PSA Reagent Kit

by Abbott Laboratories PMA

Active United States

PMA P980007

Overview

The ARCHITECT Free PSA Reagent Kit and Alinity i Free PSA Reagent Kit are microparticle enzyme immunoassays (MEIA) for the quantitative measurement of free prostate specific antigen (PSA) in human serum. These assays are intended to be used in PSA values between 4 and 10 ng/mL and non-suspicious digital rectal examination to determine the % free PSA value, which can aid in discriminating between prostate cancer and benign disease.

Supplied as reagent kits for in vitro diagnostic use, these devices are designed for use with Abbott ARCHITECT and Alinity i immunoassay systems. They are intended for professional laboratory use only and are not sterile, single-use, or MRI safety classified. Authorization is based on FDA PMA approval (P980007) under product code MTG.

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

Regulatory status

as of 26 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP980007 Date5 Feb 2004ApprovedStatusActive

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 · 1 ongoing · FDA

    • Ongoing Z-1852-2025 FDA Class II initiated 24 Apr 2025

    transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

Specification

PMA

Trade Name
Axsym Free Psa
Generic Name
Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
PMA Number
FDA Product Code
MTG
Advisory Committee
Immunology
FDA Decision
APPR Approved

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Questions

  • What is the intended use of the ARCHITECT and Alinity i Free PSA Reagent Kits?

    The ARCHITECT and Alinity i Free PSA Reagent Kits are intended for the quantitative measurement of free prostate specific antigen (PSA) in human serum. They are used in conjunction with PSA values between 4 and 10 ng/mL and non-suspicious digital rectal examination to calculate the % free PSA value, which aids in discriminating between prostate cancer and benign disease.

  • What type of assay technology do these reagent kits use?

    These reagent kits use microparticle enzyme immunoassay (MEIA) technology for the quantitative measurement of free PSA in human serum, as specified in the approval documentation for the AXSYM FREE PSA assay.

  • Are the ARCHITECT and Alinity i Free PSA Reagent Kits sterile or single-use?

    The device data does not indicate that the ARCHITECT or Alinity i Free PSA Reagent Kits are sterile or single-use. They are reagent kits designed for use with automated immunoassay systems and are intended for professional laboratory use only.