Cleared Traditional

K831177 - STRATUS DIGOXIN FLUOROMETRIC ENZYME IMM-

K831177 is the FDA 510(k) clearance for STRATUS DIGOXIN FLUOROMETRIC ENZYME IMM- by American Dade. It is a Class 2 Immunology device (product code KXT) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K831177 · American Dade · Immunology device
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May 1983
Decision
36d
Days
Class 2
Risk

K831177 is an FDA 510(k) clearance for the STRATUS DIGOXIN FLUOROMETRIC ENZYME IMM-. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by American Dade (Walker, US). The FDA issued a Cleared decision on May 17, 1983 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.3320 - the FDA immunology 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 American Dade devices

Submission Details

510(k) Number K831177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1983
Decision Date May 17, 1983
Days to Decision 36 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 104d · This submission: 36d
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 Immunology 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 K831177.
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
ENZYME-TEST DIGOXIN
K823199 · Icl Scientific · Nov 1982
ENDAB DIGOXIN KIT
K812054 · Immunotech Corp. · Aug 1981
OREIA-Q-DIG
K802358 · Organon, Inc. · Oct 1980