Cleared Traditional

SENSIBEAD EIA DIGOXIN KIT (K840673) - FDA 510(k) Clearance

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

K840673 · Terumo Medical Corp. · Chemistry device
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Mar 1984
Decision
26d
Days
Class 2
Risk

K840673 is an FDA 510(k) clearance for the SENSIBEAD EIA DIGOXIN KIT. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on March 12, 1984 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3320 - the FDA in vitro diagnostics and chemistry 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 Terumo Medical Corp. devices

Submission Details

510(k) Number K840673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1984
Decision Date March 12, 1984
Days to Decision 26 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 88d · This submission: 26d
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 Chemistry devices follow this clearance model.

Regulatory Peers - KXT Enzyme Immunoassay, Digoxin

All 55
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K840673.
EPSILON DIGOXIN TEST KIT
K842655 · Beckman Instruments, Inc. · Aug 1984
OPTIMATE DIGOXIN TEST
K841582 · Miles Laboratories, Inc. · May 1984
ACA DIGOXIN ANALYTICAL TEST PACK
K841107 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1984
SYVA ADVANCE DIGOXIN ASSAY
K833791 · Syva Co. · Jan 1984
STRATUS DIGOXIN FLUOROMETRIC ENZYME IMM-
K831177 · American Dade · May 1983
EMIT AUTO DIGOXIN ASSAY
K790937 · Syva Co. · Jun 1979