Cleared Traditional

K812901 - 125I FERRITIN RADIOIMMUNOASSAY KIT

K812901 is the FDA 510(k) clearance for 125I FERRITIN RADIOIMMUNOASSAY KIT by Bio-Ria. It is a Class 2 Chemistry device (product code DBF) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K812901 · Bio-Ria · Chemistry device
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Dec 1981
Decision
75d
Days
Class 2
Risk

K812901 is an FDA 510(k) clearance for the 125I FERRITIN RADIOIMMUNOASSAY KIT. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Bio-Ria (Mchenry, US). The FDA issued a Cleared decision on December 30, 1981 after a review of 75 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 Bio-Ria devices

Submission Details

510(k) Number K812901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1981
Decision Date December 30, 1981
Days to Decision 75 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 88d · This submission: 75d
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 64
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K812901.
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(125I) RADIOIMMUNOASSAY TEST SYS
K812786 · Corning Medical & Scientific · Oct 1981
FERRITIN KIT
K812597 · Hybritech, Inc. · Oct 1981
LEECO FERRITIN-QUANT DIAG. TEST KIT
K811880 · Leeco Diagnostics, Inc. · Jul 1981