Cleared Traditional

ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER (K002905) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K002905 · Beckman Coulter, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
31d
Days
Class 2
Risk

K002905 is an FDA 510(k) clearance for the ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER. Classified as System, Test, Thyroglobulin (product code MSW), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (San Diego, US). The FDA issued a Cleared decision on October 19, 2000 after a review of 31 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Beckman Coulter, Inc. devices

Submission Details

510(k) Number K002905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2000
Decision Date October 19, 2000
Days to Decision 31 days
Submission Type Traditional
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
73d faster than avg
Panel avg: 104d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K002905.
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 IMMUNOASSAY SYSTEMS
K031269 · Beckman Coulter, Inc. · May 2003