Cleared Traditional

K874203 - AMERLITE FERRITIN ASSAY

K874203 is the FDA 510(k) clearance for AMERLITE FERRITIN ASSAY by Amersham Corp.. It is a Class 2 Immunology device (product code DBF) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K874203 · Amersham Corp. · Immunology device
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Jan 1988
Decision
104d
Days
Class 2
Risk

K874203 is an FDA 510(k) clearance for the AMERLITE FERRITIN ASSAY, LAN.0800/1800/2800. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on January 27, 1988 after a review of 104 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Amersham Corp. devices

Submission Details

510(k) Number K874203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1987
Decision Date January 27, 1988
Days to Decision 104 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
At panel average
Panel avg: 104d · This submission: 104d
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 63
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K874203.
LAN.0800Q/2800Q
K895872 · Amersham Corp. · Oct 1989
AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)
K892362 · Amersham Corp. · May 1989
AFFINITY(TM) FERRITIN IMMUNIT(TM)
K885074 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1989
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