Cleared Traditional

K902861 - CIBA CORNING ACS DIGOXIN IMMUNOASSAY

K902861 is an FDA 510(k) clearance for CIBA CORNING ACS DIGOXIN IMMUNOASSAY, manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 2 Chemistry device with product code DON cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K902861 · Ciba Corning Diagnostics Corp. · Chemistry device
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Sep 1990
Decision
74d
Days
Class 2
Risk

K902861 is an FDA 510(k) clearance for the CIBA CORNING ACS DIGOXIN IMMUNOASSAY. Classified as Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep. (product code DON), Class II - Special Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on September 10, 1990 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3320 - the FDA in vitro diagnostics and chemistry 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 Ciba Corning Diagnostics Corp. devices

FDA 510(k) Submission Details - K902861

510(k) Number K902861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1990
Decision Date September 10, 1990
Days to Decision 74 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 88d · This submission: 74d
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 Chemistry devices follow this clearance model.

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

All 10
Devices cleared under the same product code (DON) and FDA review panel - the closest regulatory comparables to K902861.
CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY
K881679 · Ciba Corning Diagnostics Corp. · Jul 1988
MAGIC 125I DIGOXIN RADIOIMMUNOASSAY
K840461 · Corning Medical & Scientific · Mar 1984
ENZYMUNE-TEST DIGOXIN
K821000 · Icl Scientific · Apr 1982
DIGOXIN RIABEAD DIAGNOSTIC KIT
K803075 · Abbott Laboratories · Dec 1980
TECHNICON STAR SYSTEM
K791549 · Technicon Instruments Corp. · Sep 1979
RIA, DIGOXIN
K781660 · E. R. Squibb & Sons, Inc. · Oct 1978