Cleared Traditional

K811880 - LEECO FERRITIN-QUANT DIAG. TEST KIT

K811880 is an FDA 510(k) clearance for LEECO FERRITIN-QUANT DIAG. TEST KIT, manufactured by Leeco Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DBF cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K811880 · Leeco Diagnostics, Inc. · Immunology device
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Jul 1981
Decision
15d
Days
Class 2
Risk

K811880 is an FDA 510(k) clearance for the LEECO FERRITIN-QUANT DIAG. TEST KIT. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Leeco Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 16, 1981 after a review of 15 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 Leeco Diagnostics, Inc. devices

FDA 510(k) Submission Details - K811880

510(k) Number K811880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1981
Decision Date July 16, 1981
Days to Decision 15 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
90d faster than avg
Panel avg: 105d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBF Device Classification - Class 2, Special Controls

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 74
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K811880.
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
FERRITIN RIA KIT
K811804 · Amersham Corp. · Jul 1981
AUTOPAK-12 FERRITIN KIT
K811808 · Micromedic Systems · Jul 1981
FERRIZYME FERRITIN ENZYME IMMUNOASSAY
K801676 · Abbott Laboratories · Aug 1980