Cleared Traditional

K780207 - LIQUISOL DIGOXIN RIA TEST KIT

K780207 is an FDA 510(k) clearance for LIQUISOL DIGOXIN RIA TEST KIT, manufactured by Damon Corp.. The device is a Class 2 Toxicology device with product code DON cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K780207 · Damon Corp. · Toxicology device
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Feb 1978
Decision
16d
Days
Class 2
Risk

K780207 is an FDA 510(k) clearance for the LIQUISOL DIGOXIN RIA TEST KIT. Classified as Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep. (product code DON), Class II - Special Controls.

Submitted by Damon Corp. (Mchenry, US). The FDA issued a Cleared decision on February 23, 1978 after a review of 16 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 Damon Corp. devices

FDA 510(k) Submission Details - K780207

510(k) Number K780207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1978
Decision Date February 23, 1978
Days to Decision 16 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 87d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DON Device Classification - Class 2, Special Controls

Product Code DON Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep.
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 - DON Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep.

All 13
Devices cleared under the same product code (DON) and FDA review panel - the closest regulatory comparables to K780207.
TECHNICON STAR SYSTEM
K791549 · Technicon Instruments Corp. · Sep 1979
RIA, DIGOXIN
K781660 · E. R. Squibb & Sons, Inc. · Oct 1978
DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT
K780475 · Burroughs Wellcome Co. · Apr 1978
QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA
K772422 · Bio-Rad · Feb 1978
DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS
K772098 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1977
CEBTRIA DIGOXIN RIA
K771255 · Union Carbide Corp. · Aug 1977