Cleared Traditional

IMMUNODOT THYROID AUTOIMMUNITY PANEL (K903843) - FDA 510(k) Clearance

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

K903843 · General Biometrics, Inc. · Chemistry device
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Oct 1990
Decision
42d
Days
Class 2
Risk

K903843 is an FDA 510(k) clearance for the IMMUNODOT THYROID AUTOIMMUNITY PANEL. Classified as Immunochemical, Thyroglobulin Autoantibody (product code JNL), Class II - Special Controls.

Submitted by General Biometrics, Inc. (San Diego, US). The FDA issued a Cleared decision on October 2, 1990 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5870 - the FDA in vitro diagnostics and chemistry 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 General Biometrics, Inc. devices

Submission Details

510(k) Number K903843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1990
Decision Date October 02, 1990
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JNL Immunochemical, Thyroglobulin Autoantibody
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5870
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 Chemistry devices follow this clearance model.

Regulatory Peers - JNL Immunochemical, Thyroglobulin Autoantibody

All 21
Devices cleared under the same product code (JNL) and FDA review panel - the closest regulatory comparables to K903843.
ADVIA Centaur Anti-Thyroglobulin II (aTgII)
K250816 · Siemens Healthcare Diagnostics, Inc. · Dec 2025
Access Thyroglobulin Antibody II
K240996 · Beckman Coulter, Inc. · Jul 2024
ACCESS THYROGLOBULIN ANITBODY
K112933 · Beckman Coulter, Inc. · Dec 2011
ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)
K062516 · Beckman Coulter, Inc. · Oct 2006