Cleared Traditional

ENZYMUN TEST(R) FT4 (FREE THYROXINE) (K900883) - FDA 510(k) Clearance

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

K900883 · Boehringer Mannheim Corp. · Chemistry device
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May 1990
Decision
78d
Days
Class 2
Risk

K900883 is an FDA 510(k) clearance for the ENZYMUN TEST(R) FT4 (FREE THYROXINE). Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on May 15, 1990 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1695 - 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 K900883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1990
Decision Date May 15, 1990
Days to Decision 78 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
10d faster than avg
Panel avg: 88d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEC Radioimmunoassay, Free Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1695
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 - CEC Radioimmunoassay, Free Thyroxine

All 40
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K900883.
TDX FREE T4 CALCULATION
K903383 · Abbott Laboratories · Sep 1990
IMX FREE T4 CALCULATION
K903384 · Abbott Laboratories · Sep 1990
ABBOTT IMX FREE T4
K902834 · Abbott Laboratories · Sep 1990
QLIA T UPTAKE ASSAY
K883971 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1988
STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO.
K870158 · American Dade · Mar 1987
IQ FTI IMMUNOASSAY
K865104 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1987