Cleared Traditional

K801202 - DIGOXIN RADIOIMMUNOASSAY KIT

K801202 is an FDA 510(k) clearance for DIGOXIN RADIOIMMUNOASSAY KIT, manufactured by Technia Diagnostics , Ltd.. The device is a Class 2 Toxicology device with product code LCS cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K801202 · Technia Diagnostics , Ltd. · Toxicology device
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Jun 1980
Decision
32d
Days
Class 2
Risk

K801202 is an FDA 510(k) clearance for the DIGOXIN RADIOIMMUNOASSAY KIT. Classified as Radioimmunoassay, Digoxin (125-i) (product code LCS), Class II - Special Controls.

Submitted by Technia Diagnostics , Ltd. (Mchenry, US). The FDA issued a Cleared decision on June 20, 1980 after a review of 32 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 Technia Diagnostics , Ltd. devices

FDA 510(k) Submission Details - K801202

510(k) Number K801202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1980
Decision Date June 20, 1980
Days to Decision 32 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 87d · This submission: 32d
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 12
Devices cleared under the same product code (LCS) and FDA review panel - the closest regulatory comparables to K801202.
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
DIGOCTK 125
K800773 · Sorin Biomedica, Fiat, USA, Inc. · Apr 1980
PHALDEBAS DIGOXIN RIA
K770322 · Pharmacia, Inc. · Apr 1977