Cleared Traditional

K864802 - DART DIGOXIN ASSAY

K864802 is an FDA 510(k) clearance for DART DIGOXIN ASSAY, manufactured by Coulter Electronics, Inc.. The device is a Class 2 Chemistry device with product code LCS cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K864802 · Coulter Electronics, Inc. · Chemistry device
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Feb 1987
Decision
65d
Days
Class 2
Risk

K864802 is an FDA 510(k) clearance for the DART DIGOXIN ASSAY. Classified as Radioimmunoassay, Digoxin (125-i) (product code LCS), Class II - Special Controls.

Submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on February 12, 1987 after a review of 65 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 Coulter Electronics, Inc. devices

FDA 510(k) Submission Details - K864802

510(k) Number K864802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1986
Decision Date February 12, 1987
Days to Decision 65 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
23d faster than avg
Panel avg: 88d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCS Device Classification - Class 2, Special Controls

Product Code LCS Radioimmunoassay, Digoxin (125-i)
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 - LCS Radioimmunoassay, Digoxin (125-i)

All 11
Devices cleared under the same product code (LCS) and FDA review panel - the closest regulatory comparables to K864802.
INNOFLUOR DIGOXIN REAGENT SET
K895828 · Innotron of Oregon, Inc. · Oct 1989
FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT
K884707 · Cyberfluor, Inc. · Jan 1989
IMMPULSE DIGOXIN ASSAY REAGENTS
K874748 · Sclavo, Inc. · Feb 1988
TDX DIGOXIN
K820154 · Abbott Laboratories · Feb 1982
I-125 LABELED DIGOXIN
K803047 · Pcl-Ria, Inc. · Dec 1980
AMERLEX DIGOXIN RIA KIT
K801413 · Amersham Corp. · Jul 1980