Cleared Traditional

K925132 - BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE

K925132 is an FDA 510(k) clearance for BECTON DICKINSON THYROID STIMULATING HO..., manufactured by Becton Dickinson Advanced Diagnostics. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K925132 · Becton Dickinson Advanced Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
76d
Days
Class 2
Risk

K925132 is an FDA 510(k) clearance for the BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Becton Dickinson Advanced Diagnostics (Sparks, US). The FDA issued a Cleared decision on December 28, 1992 after a review of 76 days - a notably fast clearance cycle.

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: 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 Becton Dickinson Advanced Diagnostics devices

FDA 510(k) Submission Details - K925132

510(k) Number K925132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1992
Decision Date December 28, 1992
Days to Decision 76 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 88d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JLW Device Classification - Class 2, Special Controls

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 203
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K925132.
RADIAS TSH ENZYME IMMUNOASSAY
K931061 · Bio-Rad · Jun 1993
NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY
K923532 · Solarcare Technologies Corp,Inc. · Mar 1993
ACCESS HTSH ASSAY
K925637 · Bio-Rad Laboratories, Inc. · Mar 1993
DELFIA HTSH ULTRA KIT
K923401 · Wallac OY · Nov 1992
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