Cleared Traditional

K874572 - ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM

K874572 is the FDA 510(k) clearance for ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM by Nichols Institute Diagnostics. It is a Class 2 Immunology device (product code DBF) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K874572 · Nichols Institute Diagnostics · Immunology device
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Dec 1987
Decision
27d
Days
Class 2
Risk

K874572 is an FDA 510(k) clearance for the ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Nichols Institute Diagnostics (Los Angeles, US). The FDA issued a Cleared decision on December 2, 1987 after a review of 27 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 Nichols Institute Diagnostics devices

Submission Details

510(k) Number K874572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1987
Decision Date December 02, 1987
Days to Decision 27 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
77d faster than avg
Panel avg: 104d · This submission: 27d
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 K874572.
AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)
K892362 · Amersham Corp. · May 1989
AFFINITY(TM) FERRITIN IMMUNIT(TM)
K885074 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1989
AMERLITE FERRITIN ASSAY, LAN.0800/1800/2800
K874203 · Amersham Corp. · Jan 1988
IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5
K874031 · Diagnostic Products Corp. · Nov 1987
CIBA CORNING MAGIC LITE FERRITIN
K873573 · Ciba Corning Diagnostics Corp. · Oct 1987
DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM
K871489 · Diagnostic Systems Laboratories, Inc. · Jun 1987