Cleared Traditional

K904387 - BIOCLONES ELEGANCE LH ELISA KIT

K904387 is an FDA 510(k) clearance for BIOCLONES ELEGANCE LH ELISA KIT, manufactured by Bioclone Australia Pty , Ltd.. The device is a Class 1 Chemistry device with product code CEP cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K904387 · Bioclone Australia Pty , Ltd. · Chemistry device
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Nov 1990
Decision
42d
Days
Class 1
Risk

K904387 is an FDA 510(k) clearance for the BIOCLONES ELEGANCE LH ELISA KIT. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Bioclone Australia Pty , Ltd. (Washington, US). The FDA issued a Cleared decision on November 6, 1990 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1485 - 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.

FDA 510(k) Submission Details - K904387

510(k) Number K904387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1990
Decision Date November 06, 1990
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 89d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

CEP Device Classification - Class 1, General Controls

Product Code CEP Radioimmunoassay, Luteinizing Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1485
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CEP Radioimmunoassay, Luteinizing Hormone

All 142
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K904387.
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CIBA CORNING ACS LH IMMUNOASSAY
K910198 · Ciba Corning Diagnostics Corp. · Feb 1991
MILENIA (TM) LH
K902786 · Diagnostic Products Corp. · Oct 1990
IMMUNOCORP LH IRMA COATED TUBE
K903052 · Immunocorp Sciences, Inc. · Aug 1990
LUMATAG(TM) LH DIAGNOSTIC KIT
K902443 · London Diagnostics, Inc. · Aug 1990
K904387 · BIOCLONES ELEGANCE LH ELISA KIT
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