Cleared Traditional

K830591 - CORNING FERRITIN 125I RADIOIMMUNOASSAY

K830591 is the FDA 510(k) clearance for CORNING FERRITIN 125I RADIOIMMUNOASSAY by Corning Medical & Scientific. It is a Class 2 Chemistry device (product code DBF) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K830591 · Corning Medical & Scientific · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1983
Decision
28d
Days
Class 2
Risk

K830591 is an FDA 510(k) clearance for the CORNING FERRITIN 125I RADIOIMMUNOASSAY. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on March 24, 1983 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5340 - 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 Corning Medical & Scientific devices

Submission Details

510(k) Number K830591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1983
Decision Date March 24, 1983
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DBF Ferritin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5340
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 - DBF Ferritin, Antigen, Antiserum, Control

All 62
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K830591.
ENZYMUN-TEST FERRITIN
K860137 · Boehringer Mannheim Corp. · Mar 1986
STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY
K844158 · American Dade · Nov 1984
DSL FERRITIN IRMA
K841925 · Diagnostic Systems Laboratories, Inc. · May 1984
TANDEM-E -FER IMMUNOENZYMETRIC KIT
K823871 · Hybritech, Inc. · Feb 1983
AUTOPAK FERRITIN TEST DELIVERY SYS
K823275 · Micromedic Systems · Dec 1982
ANTISERA TO HUMAN FERRITIN
K822472 · Kent Laboratories, Inc. · Sep 1982