Cleared Traditional

K874203 - AMERLITE FERRITIN ASSAY, LAN.0800/1800/2800

K874203 is an FDA 510(k) clearance for AMERLITE FERRITIN ASSAY, manufactured by Amersham Corp.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K874203

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
1d faster than avg
Panel avg: 105d · This submission: 104d
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 75
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K874203.
AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)
K892362 · Amersham Corp. · May 1989
AFFINITY(TM) FERRITIN IMMUNIT(TM)
K885074 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1989
FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY
K884683 · Serono-Baker Diagnostics, Inc. · Dec 1988
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