Cleared Special

ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (K031269) - FDA 510(k) Clearance

Class II Immunology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K031269 · Beckman Coulter, Inc. · Immunology device
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Optimized for regulatory review, auditing and printing
May 2003
Decision
11d
Days
Class 2
Risk

K031269 is an FDA 510(k) clearance for the ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS. Classified as System, Test, Thyroglobulin (product code MSW), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on May 2, 2003 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - the FDA immunology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Beckman Coulter, Inc. devices

Submission Details

510(k) Number K031269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2003
Decision Date May 02, 2003
Days to Decision 11 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 104d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MSW System, Test, Thyroglobulin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - MSW System, Test, Thyroglobulin

All 12
Devices cleared under the same product code (MSW) and FDA review panel - the closest regulatory comparables to K031269.
Atellica IM Thyroglobulin (Tg)
K242981 · Siemens Healthcare Diagnostics, Inc. · Jun 2025
Access Thyroglobulin
K240927 · Beckman Coulter, Inc. · Jun 2024
Access Thyroglobulin
K241423 · Beckman Coulter, Inc. · Jun 2024
Elecsys Tg II
K221890 · Roche Diagnostics · Sep 2023
Access Thyroglobulin
K220972 · Beckman Coulter, Inc. · Sep 2023
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER
K002905 · Beckman Coulter, Inc. · Oct 2000