Cleared Traditional

K925637 - ACCESS HTSH ASSAY

K925637 is the FDA 510(k) clearance for ACCESS HTSH ASSAY by Bio-Rad Laboratories, Inc.. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K925637 · Bio-Rad Laboratories, Inc. · Chemistry device
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Mar 1993
Decision
112d
Days
Class 2
Risk

K925637 is an FDA 510(k) clearance for the ACCESS HTSH ASSAY. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on March 1, 1993 after a review of 112 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 Bio-Rad Laboratories, Inc. devices

Submission Details

510(k) Number K925637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1992
Decision Date March 01, 1993
Days to Decision 112 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 88d · This submission: 112d
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 123
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K925637.
COBAS CORE TSH EIA
K930776 · Roche Diagnostic Systems, Inc. · Dec 1993
SIA THYROID STIMULATING HORMONE ELISA KIT
K930050 · Sigma Chemical Co. · Aug 1993
RADIAS TSH ENZYME IMMUNOASSAY
K931061 · Bio-Rad · Jun 1993
DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD
K922701 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1992
VISTA ULTRASENSITIVE HTSH ASSAY
K922138 · Syva Co. · Jul 1992
KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA
K922736 · Eastman Kodak Company · Jul 1992