Cleared Traditional

K021057 - BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS

K021057 is an FDA 510(k) clearance for BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS, manufactured by Brahms Diagnostica, LLC. The device is a Class 2 Immunology device with product code MSW cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K021057 · Brahms Diagnostica, LLC · Immunology device
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Sep 2002
Decision
169d
Days
Class 2
Risk

K021057 is an FDA 510(k) clearance for the BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS. Classified as System, Test, Thyroglobulin (product code MSW), Class II - Special Controls.

Submitted by Brahms Diagnostica, LLC (Norcross, US). The FDA issued a Cleared decision on September 17, 2002 after a review of 169 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Brahms Diagnostica, LLC devices

FDA 510(k) Submission Details - K021057

510(k) Number K021057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2002
Decision Date September 17, 2002
Days to Decision 169 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 105d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSW Device Classification - Class 2, Special Controls

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 K021057.
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
NICHOLS ADVANTAGE THYROGLOB
K002888 · Nichols Institute Diagnostics · Oct 2000
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER
K002905 · Beckman Coulter, Inc. · Oct 2000
NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240
K994140 · Nichols Institute Diagnostics · May 2000