Cleared Traditional

K801413 - AMERLEX DIGOXIN RIA KIT

K801413 is an FDA 510(k) clearance for AMERLEX DIGOXIN RIA KIT, manufactured by Amersham Corp.. The device is a Class 2 Toxicology device with product code LCS cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K801413 · Amersham Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1980
Decision
22d
Days
Class 2
Risk

K801413 is an FDA 510(k) clearance for the AMERLEX DIGOXIN RIA KIT. Classified as Radioimmunoassay, Digoxin (125-i) (product code LCS), Class II - Special Controls.

Submitted by Amersham Corp. (Mchenry, US). The FDA issued a Cleared decision on July 8, 1980 after a review of 22 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 Amersham Corp. devices

FDA 510(k) Submission Details - K801413

510(k) Number K801413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1980
Decision Date July 08, 1980
Days to Decision 22 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
65d faster than avg
Panel avg: 87d · This submission: 22d
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 11
Devices cleared under the same product code (LCS) and FDA review panel - the closest regulatory comparables to K801413.
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
DIGOXIN CLASP RIA KIT
K800997 · E. R. Squibb & Sons, Inc. · May 1980
DIGOCTK 125
K800773 · Sorin Biomedica, Fiat, USA, Inc. · Apr 1980
PHALDEBAS DIGOXIN RIA
K770322 · Pharmacia, Inc. · Apr 1977