Cleared Traditional

IMX DIGOXIN (K952079) - FDA 510(k) Clearance

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

K952079 · Abbott Laboratories · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
77d
Days
Class 2
Risk

K952079 is an FDA 510(k) clearance for the IMX DIGOXIN. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 19, 1995 after a review of 77 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 Abbott Laboratories devices

Submission Details

510(k) Number K952079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1995
Decision Date July 19, 1995
Days to Decision 77 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
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: 87d · This submission: 77d
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 K952079.
CEDIA DIGOXIN
K970881 · Boehringer Mannheim Corp. · May 1997
IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2
K963062 · Beckman Instruments, Inc. · Dec 1996
AXSYM DIGOXIN II
K953718 · Abbott Laboratories · Sep 1995
IL TEST DIGOXIN, PN 181761-00
K951391 · Instrumentation Laboratory CO · Jun 1995
DUPONT ACA DIGOXIN (DGN A) METHOD
K951441 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1995
EMIT 2000 DIGOXIN ASSAY
K951755 · Syva Co. · Jun 1995