Cleared Traditional

K812786 - FERRITIN(125I) RADIOIMMUNOASSAY TEST SYS

K812786 is the FDA 510(k) clearance for FERRITIN(125I) RADIOIMMUNOASSAY TEST SYS by Corning Medical & Scientific. It is a Class 2 Immunology device (product code DBF) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K812786 · Corning Medical & Scientific · Immunology device
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Oct 1981
Decision
18d
Days
Class 2
Risk

K812786 is an FDA 510(k) clearance for the FERRITIN(125I) RADIOIMMUNOASSAY TEST SYS. 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 October 23, 1981 after a review of 18 days - a notably fast clearance cycle.

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

Submission Details

510(k) Number K812786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1981
Decision Date October 23, 1981
Days to Decision 18 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
86d faster than avg
Panel avg: 104d · This submission: 18d
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 Immunology 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 K812786.
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
FERRITIN KIT
K812597 · Hybritech, Inc. · Oct 1981
LEECO FERRITIN-QUANT DIAG. TEST KIT
K811880 · Leeco Diagnostics, Inc. · Jul 1981
FERRITIN RIA KIT
K811804 · Amersham Corp. · Jul 1981