Cleared Traditional

K801490 - DIGOXIN EIA KIT

K801490 is the FDA 510(k) clearance for DIGOXIN EIA KIT by M.A. Bioproducts. It is a Class 2 Toxicology device (product code LCS) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K801490 · M.A. Bioproducts · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1980
Decision
18d
Days
Class 2
Risk

K801490 is an FDA 510(k) clearance for the DIGOXIN EIA KIT. Classified as Radioimmunoassay, Digoxin (125-i) (product code LCS), Class II - Special Controls.

Submitted by M.A. Bioproducts (Mchenry, US). The FDA issued a Cleared decision on July 14, 1980 after a review of 18 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 M.A. Bioproducts devices

Submission Details

510(k) Number K801490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1980
Decision Date July 14, 1980
Days to Decision 18 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 87d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 7
Devices cleared under the same product code (LCS) and FDA review panel - the closest regulatory comparables to K801490.
DART DIGOXIN ASSAY
K864802 · Coulter Electronics, Inc. · Feb 1987
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
DIGOXIN CLASP RIA KIT
K800997 · E. R. Squibb & Sons, Inc. · May 1980
PHALDEBAS DIGOXIN RIA
K770322 · Pharmacia, Inc. · Apr 1977