Cleared Traditional

K830533 - PHASE II DIGOXIN RADIOIMMUNOASSAY KIT

K830533 is the FDA 510(k) clearance for PHASE II DIGOXIN RADIOIMMUNOASSAY KIT by Medical & Scientific Designs, Inc.. It is a Class 2 Chemistry device (product code DON) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K830533 · Medical & Scientific Designs, Inc. · Chemistry device
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Apr 1983
Decision
46d
Days
Class 2
Risk

K830533 is an FDA 510(k) clearance for the PHASE II DIGOXIN RADIOIMMUNOASSAY KIT. Classified as Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep. (product code DON), Class II - Special Controls.

Submitted by Medical & Scientific Designs, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 5, 1983 after a review of 46 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 Medical & Scientific Designs, Inc. devices

Submission Details

510(k) Number K830533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1983
Decision Date April 05, 1983
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 88d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 11
Devices cleared under the same product code (DON) and FDA review panel - the closest regulatory comparables to K830533.
CIBA CORNING ACS DIGOXIN IMMUNOASSAY
K902861 · Ciba Corning Diagnostics Corp. · Sep 1990
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