Cleared Traditional

THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST (K961629) - FDA 510(k) Clearance

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

K961629 · Teco Diagnostics · Chemistry device
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Sep 1996
Decision
138d
Days
Class 2
Risk

K961629 is an FDA 510(k) clearance for the THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Teco Diagnostics (Placentia, US). The FDA issued a Cleared decision on September 11, 1996 after a review of 138 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.

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Submission Details

510(k) Number K961629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1996
Decision Date September 11, 1996
Days to Decision 138 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
50d slower than avg
Panel avg: 88d · This submission: 138d
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 96
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K961629.
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K983442 · Abbott Laboratories · Nov 1998
3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K981312 · Bayer Corp. · Jun 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