Cleared Traditional

ACS DIGOXIN IMMUNOASSAY (K931213) - FDA 510(k) Clearance

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

K931213 · Ciba Corning Diagnostics Corp. · Toxicology device
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Jun 1993
Decision
89d
Days
Class 2
Risk

K931213 is an FDA 510(k) clearance for the ACS DIGOXIN IMMUNOASSAY. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on June 7, 1993 after a review of 89 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 Ciba Corning Diagnostics Corp. devices

Submission Details

510(k) Number K931213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1993
Decision Date June 07, 1993
Days to Decision 89 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 87d · This submission: 89d
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 46
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K931213.
DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET
K940569 · Sigma Diagnostics, Inc. · Jul 1994
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION
K934135 · Syva Co. · Apr 1994
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
ENZYMUN TEST(R) DIGOXIN
K901216 · Boehringer Mannheim Corp. · May 1990