Cleared Traditional

K801676 - FERRIZYME FERRITIN ENZYME IMMUNOASSAY

K801676 is an FDA 510(k) clearance for FERRIZYME FERRITIN ENZYME IMMUNOASSAY, manufactured by Abbott Laboratories. The device is a Class 2 Immunology device with product code DBF cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K801676 · Abbott Laboratories · Immunology device
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Aug 1980
Decision
29d
Days
Class 2
Risk

K801676 is an FDA 510(k) clearance for the FERRIZYME FERRITIN ENZYME IMMUNOASSAY. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 20, 1980 after a review of 29 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K801676

510(k) Number K801676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1980
Decision Date August 20, 1980
Days to Decision 29 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
75d faster than avg
Panel avg: 104d · This submission: 29d
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 64
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K801676.
LEECO FERRITIN-QUANT DIAG. TEST KIT
K811880 · Leeco Diagnostics, Inc. · Jul 1981
FERRITIN RIA KIT
K811804 · Amersham Corp. · Jul 1981
AUTOPAK-12 FERRITIN KIT
K811808 · Micromedic Systems · Jul 1981
FERRITIN RIA KIT
K801580 · Diagnostic Products Corp. · Aug 1980
FERRITIN CONTROLS CODE QAS.104
K800657 · Amersham Corp. · Apr 1980
FERRITIN RIA KIT
K800299 · Amersham Corp. · Mar 1980