Cleared Traditional

K936010 - THYROGLOBULIN AUTOANTIBODY ENZYME IMMUN...

K936010 is an FDA 510(k) clearance for THYROGLOBULIN AUTOANTIBODY ENZYME IMMUN..., manufactured by Biomerica, Inc.. The device is a Class 2 Immunology device with product code DDC cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K936010 · Biomerica, Inc. · Immunology device
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Jul 1994
Decision
214d
Days
Class 2
Risk

K936010 is an FDA 510(k) clearance for the THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY. Classified as Thyroglobulin, Antigen, Antiserum, Control (product code DDC), Class II - Special Controls.

Submitted by Biomerica, Inc. (Newport Beach, US). The FDA issued a Cleared decision on July 18, 1994 after a review of 214 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5870 - 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 Biomerica, Inc. devices

FDA 510(k) Submission Details - K936010

510(k) Number K936010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1993
Decision Date July 18, 1994
Days to Decision 214 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 104d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DDC Device Classification - Class 2, Special Controls

Product Code DDC Thyroglobulin, Antigen, Antiserum, Control
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 Immunology devices follow this clearance model.

Regulatory Peers - DDC Thyroglobulin, Antigen, Antiserum, Control

All 8
Devices cleared under the same product code (DDC) and FDA review panel - the closest regulatory comparables to K936010.
ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.
K991610 · Zeus Scientific, Inc. · Jun 1999
ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
K991179 · Zeus Scientific, Inc. · Jun 1999
AUTOSTAT II ANTI-THYROGLOBULIN
K943625 · Cogent Diagnotics , Ltd. · Dec 1994
QUANTA LITE(TM) THYROID T ELISA
K930486 · Inova Diagnostics, Inc. · Mar 1993
SERA-TEK THYROGLOBULIN ANTIBODY TEST
K865020 · Miles Laboratories, Inc. · Feb 1987