Cleared Traditional

K915195 - ENZYMUN-TEST TSH

K915195 is an FDA 510(k) clearance for ENZYMUN-TEST TSH, 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 87-day FDA review.

K915195 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1992
Decision
87d
Days
Class 2
Risk

K915195 is an FDA 510(k) clearance for the ENZYMUN-TEST TSH. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on February 14, 1992 after a review of 87 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K915195

510(k) Number K915195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1991
Decision Date February 14, 1992
Days to Decision 87 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
1d faster than avg
Panel avg: 88d · This submission: 87d
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 K915195.
TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093
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K920856 · Hycor Biomedical, Inc. · Mar 1992
ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT
K914756 · Medix Biotech, Inc. · Jan 1992
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K912852 · Baxter Healthcare Corp · Sep 1991
MAGIC LITE TSH (HS) IMMUNOASSAY
K912583 · Ciba Corning Diagnostics Corp. · Aug 1991