Cleared Traditional

ENZYMUN TEST(R) TSH-S (K900277) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 69
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K900277.
STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY
K912241 · Baxter Healthcare Corp · Jun 1991
NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY
K912324 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1991
NOVAPATH TSH ENZYME IMMUNOASSAY
K903311 · Bio-Rad · Sep 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