Cleared Traditional

K772422 - QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA

K772422 is an FDA 510(k) clearance for QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA, manufactured by Bio-Rad. The device is a Class 2 Immunology device with product code DON cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K772422 · Bio-Rad · Immunology device
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Feb 1978
Decision
47d
Days
Class 2
Risk

K772422 is an FDA 510(k) clearance for the QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA. Classified as Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep. (product code DON), Class II - Special Controls.

Submitted by Bio-Rad (Mchenry, US). The FDA issued a Cleared decision on February 13, 1978 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.3320 - the FDA immunology 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 Bio-Rad devices

FDA 510(k) Submission Details - K772422

510(k) Number K772422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1977
Decision Date February 13, 1978
Days to Decision 47 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 105d · This submission: 47d
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 Immunology devices follow this clearance model.

Regulatory Peers - DON Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep.

All 12
Devices cleared under the same product code (DON) and FDA review panel - the closest regulatory comparables to K772422.
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
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
CAMMADISK DIGOXIN
K770269 · Burroughs Wellcome Co. · Mar 1977