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Access Total T3 Reagents on the Access Immunoassay Analyzer

by Beckman Instruments, Inc. 510(k)

Active United States

510(k) K973966

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK973966 Date31 Oct 1997ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

3 recalls · FDA

    • Terminated Z-2239-2020 FDA Class II initiated 30 Apr 2019

    The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, and TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.

    • Terminated Z-2635-2017 FDA Class II initiated 9 May 2017

    The Access immunoassays are susceptible to biotin interference.

    • Terminated Z-2227-2012 FDA Class III initiated 11 Oct 2011

    A recall was initiated because Beckman Coulter has identified a negative bias in test results when comparing elevated Total T3 patient samples diluted with Sample Diluent A to samples diluted with Access Total T3 Calibrator S0.

Specification

510(k)

510(k) Number
FDA Product Code
CDP
Device Class
Class II
Regulation
21 CFR Part 862.1710
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Access Total T3 Reagents on the Access Immunoassay Analyzer is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of triiodothyronine levels in human serum and plasma. It is classified as a Radioimmunoassay, Total Triiodothyronine device under product code CDP and device class 2.

The device is supplied for use with the Access Immunoassay Systems and was cleared via FDA 510(k) submission K973966 on October 31, 1997, as substantially equivalent to a predicate device. It is intended for in vitro diagnostic use in clinical chemistry settings.

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Access Total T3 Reagents used for?

    It is used for the quantitative determination of triiodothyronine (T3) levels in human serum and plasma as an in vitro diagnostic test in clinical chemistry settings.

  • How is the Access Total T3 Reagents supplied and what system is it designed for?

    The reagents are supplied for use with the Access Immunoassay Systems, specifically the Access Immunoassay Analyzer, and are intended for in vitro diagnostic use in clinical laboratories.

  • Is the Access Total T3 Reagents a single-use or reusable device?

    As an in vitro diagnostic reagent kit, it is intended for single-use in each test run; the reagents are consumed during the assay process and not reused.