Cleared Traditional

K900277 - ENZYMUN TEST TSH-S

K900277 is an FDA 510(k) clearance for ENZYMUN TEST TSH-S, 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 82-day FDA review.

K900277 · Boehringer Mannheim Corp. · Chemistry device
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Apr 1990
Decision
82d
Days
Class 2
Risk

K900277 is an FDA 510(k) clearance for the ENZYMUN TEST(R) TSH-S. 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 April 11, 1990 after a review of 82 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 - K900277

510(k) Number K900277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1990
Decision Date April 11, 1990
Days to Decision 82 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 88d · This submission: 82d
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 K900277.
EZ-BEAD TSH ENZYME IMMUNOASSAY KIT
K903725 · Immunotech Corp. · Oct 1990
NOVAPATH TSH ENZYME IMMUNOASSAY
K903311 · Bio-Rad · Sep 1990
OPUS TSH TEST SYSTEM
K902333 · Pb Diagnostic Systems, Inc. · Jul 1990
AFFINITY(TM) HTSH(TM)
K897138 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1990
MILENIA (TM) TSH
K900014 · Diagnostic Products Corp. · Jan 1990
COTUBE(TM) TSH IRMA
K890802 · Bio-Rad · Mar 1989