Cleared Traditional

K901216 - ENZYMUN TEST DIGOXIN

K901216 is an FDA 510(k) clearance for ENZYMUN TEST DIGOXIN, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Toxicology device with product code KXT cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K901216 · Boehringer Mannheim Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K901216

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.

KXT Device Classification - Class 2, Special Controls

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 71
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K901216.
CEDIA(R) DIGOXIN R' ASSAY
K911941 · Microgenics Corp. · May 1991
CEDIA(R) DIGOXIN SC ASSAY
K910642 · Microgenics Corp. · Mar 1991
OPUS(TM) DIGOXIN TEST SYSTEM
K901547 · Pb Diagnostic Systems, Inc. · Jun 1990
EZ-BEAD DIGOXIN EIA KIT
K893843 · Immunotech Corp. · Sep 1989
EMIT CONVENIENCE PACK: DIGOXIN ASSAY
K893910 · Syva Co. · Aug 1989
SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES
K884528 · Heraeus Kulzer, Inc. · Mar 1989