Cleared Traditional

K892362 - AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)

K892362 is an FDA 510(k) clearance for AMERLITE FERRITIN ASSAY (ADDITIONAL PRO..., 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 33-day FDA review.

K892362 · Amersham Corp. · Immunology device
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May 1989
Decision
33d
Days
Class 2
Risk

K892362 is an FDA 510(k) clearance for the AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL). 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 May 9, 1989 after a review of 33 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 Amersham Corp. devices

FDA 510(k) Submission Details - K892362

510(k) Number K892362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1989
Decision Date May 09, 1989
Days to Decision 33 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
72d faster than avg
Panel avg: 105d · This submission: 33d
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 K892362.
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AMERLITE FERRITIN ASSAY, LAN.0800/1800/2800
K874203 · Amersham Corp. · Jan 1988