Cleared Traditional

ELEGANCE FERRITIN ELISA (K904822) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K904822 · Bioclone Australia Pty , Ltd. · Immunology device
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Nov 1990
Decision
36d
Days
Class 2
Risk

K904822 is an FDA 510(k) clearance for the ELEGANCE FERRITIN ELISA. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Bioclone Australia Pty , Ltd. (Washington, US). The FDA issued a Cleared decision on November 29, 1990 after a review of 36 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 Bioclone Australia Pty , Ltd. devices

Submission Details

510(k) Number K904822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1990
Decision Date November 29, 1990
Days to Decision 36 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 104d · This submission: 36d
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 86
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K904822.
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Atellica IM Ferritin Assay
K171642 · Siemens Healthcare Diagnostics, Inc. · Aug 2017
BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203
K092505 · Beckman Coulter, Inc. · Dec 2009
QUANTEX FERRITIN
K040879 · Instrumentation Laboratory CO · May 2004
FERRITIN GENERATION 2
K031650 · Roche Diagnostics Corp. · Jul 2003