Cleared Traditional

K871489 - DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM

K871489 is the FDA 510(k) clearance for DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM by Diagnostic Systems Laboratories, Inc.. It is a Class 2 Immunology device (product code DBF) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K871489 · Diagnostic Systems Laboratories, Inc. · Immunology device
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Jun 1987
Decision
58d
Days
Class 2
Risk

K871489 is an FDA 510(k) clearance for the DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on June 12, 1987 after a review of 58 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 Diagnostic Systems Laboratories, Inc. devices

Submission Details

510(k) Number K871489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1987
Decision Date June 12, 1987
Days to Decision 58 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
46d faster than avg
Panel avg: 104d · This submission: 58d
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 K871489.
ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM
K874572 · Nichols Institute Diagnostics · Dec 1987
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
FERRITIN MAB SOLID PHASE COMPONENT SYSTEM
K870570 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1987
COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS
K870107 · Diagnostic Products Corp. · Feb 1987
BECKMAN EPSILON(TM) FERRITIN TEST KIT
K864437 · Beckman Instruments, Inc. · Jan 1987