Cleared Traditional

K904822 - ELEGANCE FERRITIN ELISA

K904822 is an FDA 510(k) clearance for ELEGANCE FERRITIN ELISA, manufactured by Bioclone Australia Pty , Ltd.. The device is a Class 2 Immunology device with product code DBF cleared through the Traditional 510(k) pathway after a 36-day FDA review.

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

FDA 510(k) Submission Details - K904822

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
69d faster than avg
Panel avg: 105d · This submission: 36d
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 76
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K904822.
MODIFIED FERRITIN ENZYME IMUNOASSAY TEST KIT
K920046 · Medix Biotech, Inc. · Jan 1992
SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE)
K911175 · Serono-Baker Diagnostics, Inc. · Apr 1991
CIBA CORNING ACS FERRITIN IMMUNOASSAY
K905770 · Ciba Corning Diagnostics Corp. · Mar 1991
MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT
K896585 · Medix Biotech, Inc. · Dec 1989
LAN.0800Q/2800Q
K895872 · Amersham Corp. · Oct 1989
AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)
K892362 · Amersham Corp. · May 1989