Cleared Traditional

K901086 - ENZYMUN TEST T4 (TOTAL THYROXINE)

K901086 is an FDA 510(k) clearance for ENZYMUN TEST T4 (TOTAL THYROXINE), manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Chemistry device with product code KLT cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K901086 · Boehringer Mannheim Corp. · Chemistry device
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Mar 1990
Decision
21d
Days
Class 2
Risk

K901086 is an FDA 510(k) clearance for the ENZYMUN TEST(R) T4 (TOTAL THYROXINE). Classified as Enzyme Immunoassay, Carbamazepine (product code KLT), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on March 30, 1990 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3645 - 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 - K901086

510(k) Number K901086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1990
Decision Date March 30, 1990
Days to Decision 21 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
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLT Device Classification - Class 2, Special Controls

Product Code KLT Enzyme Immunoassay, Carbamazepine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3645
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 - KLT Enzyme Immunoassay, Carbamazepine

All 45
Devices cleared under the same product code (KLT) and FDA review panel - the closest regulatory comparables to K901086.
ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI
K926441 · Roche Diagnostic Systems, Inc. · May 1993
CEDIA(R) CARBAMAZEPINE ASSAY
K914857 · Microgenics Corp. · Jan 1992
EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS
K913066 · Syva Co. · Jul 1991
EMIT CONVENIENCE PACK: CARBAMAZEPINE ASSAY
K897114 · Syva Co. · Jan 1990
OPUS CARBAMAZEPINE TEST SYSTEM
K896860 · Pb Diagnostic Systems, Inc. · Jan 1990
INNOFLUOR CARBAMAZEPINE REAGENT SET
K893507 · Innotron of Oregon, Inc. · Aug 1989