Cleared Traditional

ENZYMUN TEST(R) DIGOXIN (K901216) - FDA 510(k) Clearance

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

K901216 · Boehringer Mannheim Corp. · Toxicology device
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May 1990
Decision
78d
Days
Class 2
Risk

K901216 is an FDA 510(k) clearance for the ENZYMUN TEST(R) DIGOXIN. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on May 31, 1990 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3320 - the FDA toxicology device 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 K901216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1990
Decision Date May 31, 1990
Days to Decision 78 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 87d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KXT Enzyme Immunoassay, Digoxin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3320
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 Toxicology devices follow this clearance model.

Regulatory Peers - KXT Enzyme Immunoassay, Digoxin

All 43
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K901216.
DIGOXIN TEST SYSTEM, KXT TX
K931123 · Syva Co. · Aug 1993
ACA DIGOXIN ANALYTICAL TEST PACK
K930162 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1993
IL TEST(TM DIGOXIN
K914151 · Instrumentation Laboratory CO · Nov 1991
EMIT CONVENIENCE PACK: DIGOXIN ASSAY
K893910 · Syva Co. · Aug 1989
SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES
K884528 · Heraeus Kulzer, Inc. · Mar 1989
TDX (R) DIGOXIN NXT
K882233 · Abbott Laboratories · Jul 1988