Cleared Traditional

K820154 - TDX DIGOXIN

K820154 is an FDA 510(k) clearance for TDX DIGOXIN, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code LCS cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K820154 · Abbott Laboratories · Toxicology device
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Feb 1982
Decision
17d
Days
Class 2
Risk

K820154 is an FDA 510(k) clearance for the TDX DIGOXIN. Classified as Radioimmunoassay, Digoxin (125-i) (product code LCS), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on February 5, 1982 after a review of 17 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

FDA 510(k) Submission Details - K820154

510(k) Number K820154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1982
Decision Date February 05, 1982
Days to Decision 17 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
70d faster than avg
Panel avg: 87d · This submission: 17d
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 Toxicology devices follow this clearance model.

Regulatory Peers - LCS Radioimmunoassay, Digoxin (125-i)

All 8
Devices cleared under the same product code (LCS) and FDA review panel - the closest regulatory comparables to K820154.
INNOFLUOR DIGOXIN REAGENT SET
K895828 · Innotron of Oregon, Inc. · Oct 1989
IMMPULSE DIGOXIN ASSAY REAGENTS
K874748 · Sclavo, Inc. · Feb 1988
DART DIGOXIN ASSAY
K864802 · Coulter Electronics, Inc. · Feb 1987
I-125 LABELED DIGOXIN
K803047 · Pcl-Ria, Inc. · Dec 1980
AMERLEX DIGOXIN RIA KIT
K801413 · Amersham Corp. · Jul 1980
DIGOXIN CLASP RIA KIT
K800997 · E. R. Squibb & Sons, Inc. · May 1980