Cleared Traditional

K884683 - FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY

K884683 is the FDA 510(k) clearance for FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY by Serono-Baker Diagnostics, Inc.. It is a Class 2 Chemistry device (product code DBF) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K884683 · Serono-Baker Diagnostics, Inc. · Chemistry device
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Dec 1988
Decision
49d
Days
Class 2
Risk

K884683 is an FDA 510(k) clearance for the FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Serono-Baker Diagnostics, Inc. (Allentown, US). The FDA issued a Cleared decision on December 27, 1988 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5340 - the FDA in vitro diagnostics and chemistry 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 Serono-Baker Diagnostics, Inc. devices

Submission Details

510(k) Number K884683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1988
Decision Date December 27, 1988
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
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 Chemistry 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 K884683.
LAN.0800Q/2800Q
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AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)
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K874203 · Amersham Corp. · Jan 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