Cleared Traditional

K841582 - OPTIMATE DIGOXIN TEST

K841582 is the FDA 510(k) clearance for OPTIMATE DIGOXIN TEST by Miles Laboratories, Inc.. It is a Class 2 Toxicology device (product code KXT) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K841582 · Miles Laboratories, Inc. · Toxicology device
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May 1984
Decision
24d
Days
Class 2
Risk

K841582 is an FDA 510(k) clearance for the OPTIMATE DIGOXIN TEST. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 11, 1984 after a review of 24 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K841582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1984
Decision Date May 11, 1984
Days to Decision 24 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
63d faster than avg
Panel avg: 87d · This submission: 24d
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 69
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K841582.
COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C
K851032 · Roche Diagnostic Systems, Inc. · Apr 1985
DUPONT DIGOXIN ASSAY REAGENTS
K850458 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1985
EPSILON DIGOXIN TEST KIT
K842655 · Beckman Instruments, Inc. · Aug 1984
ACA DIGOXIN ANALYTICAL TEST PACK
K841107 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1984
SENSIBEAD EIA DIGOXIN KIT
K840673 · Terumo Medical Corp. · Mar 1984
SYVA ADVANCE DIGOXIN ASSAY
K833791 · Syva Co. · Jan 1984