Cleared Traditional

K803060 - FOLATE 125I RADIOIMMUNOASSAY

K803060 is the FDA 510(k) clearance for FOLATE 125I RADIOIMMUNOASSAY by Corning Medical & Scientific. It is a Class 2 Chemistry device (product code CGN) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K803060 · Corning Medical & Scientific · Chemistry device
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Dec 1980
Decision
101d
Days
Class 2
Risk

K803060 is an FDA 510(k) clearance for the FOLATE 125I RADIOIMMUNOASSAY. Classified as Acid, Folic, Radioimmunoassay (product code CGN), Class II - Special Controls.

Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on December 22, 1980 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1295 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Corning Medical & Scientific devices

Submission Details

510(k) Number K803060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1980
Decision Date December 22, 1980
Days to Decision 101 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
13d slower than avg
Panel avg: 88d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGN Acid, Folic, Radioimmunoassay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1295
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 - CGN Acid, Folic, Radioimmunoassay

All 50
Devices cleared under the same product code (CGN) and FDA review panel - the closest regulatory comparables to K803060.
QUANTA PHASE VITAMIN B-12/FOLATE RAD
K811177 · Bio-Rad · May 1981
MICROMEDIC SYSTEMS' AUTOPAK
K810186 · Micromedic Systems · Feb 1981
'NO-BOIL' DUALCOUNT KIT
K810001 · Diagnostic Products Corp. · Jan 1981
FOLATE RADIOASSAY KIT
K801198 · Calbiochem-Behring Corp. · Jul 1980
125 I FOLATE SOLID PHASE RADIOASSAY
K792167 · Abbott Laboratories · Nov 1979
FOLATE REAGENT KIT, ARIA-II SYSTEM
K780557 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1978