Cleared Traditional

K961491 - ELECSYS TSH ASSAY

K961491 is an FDA 510(k) clearance for ELECSYS TSH ASSAY, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K961491 · Boehringer Mannheim Corp. · Chemistry device
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Optimized for regulatory review, auditing and printing
Jul 1996
Decision
95d
Days
Class 2
Risk

K961491 is an FDA 510(k) clearance for the ELECSYS TSH ASSAY. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on July 22, 1996 after a review of 95 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K961491

510(k) Number K961491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1996
Decision Date July 22, 1996
Days to Decision 95 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
7d slower than avg
Panel avg: 88d · This submission: 95d
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 156
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K961491.
AIA-PACK TSH 3RD-GEN ASSAY
K972586 · Tosoh Medics, Inc. · Aug 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001)
K964558 · Johnson & Johnson Clinical Diagnostics, Inc. · Dec 1996
THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST
K961629 · Teco Diagnostics · Sep 1996
NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING HORMONE THIRD GENERATION KIT
K961650 · Nichols Institute Diagnostics · Jul 1996
ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K954825 · Bio-Rad Laboratories, Inc. · Nov 1995
AMERLITE TSH-30 ULTRASENSITIVE ASSAY (LAN.0010Q/2010Q)
K952211 · Johnson & Johnson Clinical Diagnostics, Inc. · Jul 1995