Cleared Traditional

TSH (MICROWELL) ELISA (K962216) - FDA 510(k) Clearance

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

K962216 · Biomerica, Inc. · Chemistry device
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Sep 1996
Decision
101d
Days
Class 2
Risk

K962216 is an FDA 510(k) clearance for the TSH (MICROWELL) ELISA. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Biomerica, Inc. (Newport Beach, US). The FDA issued a Cleared decision on September 19, 1996 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1690 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomerica, Inc. devices

Submission Details

510(k) Number K962216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1996
Decision Date September 19, 1996
Days to Decision 101 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 88d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JLW Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1690
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 - JLW Radioimmunoassay, Thyroid-stimulating Hormone

All 77
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K962216.
ACCESS HYPERSENSITIVE HTSH ASSAY
K023093 · Beckman Coulter, Inc. · Nov 2002
ABBOTT ARCHITECT TSH
K983442 · Abbott Laboratories · Nov 1998
ABBOTT AXSYM 3RD GENERATION TSH ASSAY
K981060 · Abbott Laboratories · Apr 1998
ELECSYS TSH ASSAY
K961491 · Boehringer Mannheim Corp. · Jul 1996
AXSYM ULTRASENSITIVE HTSH II
K952148 · Abbott Laboratories · Jun 1995
CIBA CORNING ACS THYROID STIMULATING HORMONE (TSH-3) IMMUNOASSAY
K951796 · Ciba Corning Diagnostics Corp. · Jun 1995