Cleared Traditional

K905099 - ELEGANCE TSH ELISA

K905099 is an FDA 510(k) clearance for ELEGANCE TSH ELISA, manufactured by Bioclone Australia Pty , Ltd.. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K905099 · Bioclone Australia Pty , Ltd. · Chemistry device
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Dec 1990
Decision
35d
Days
Class 2
Risk

K905099 is an FDA 510(k) clearance for the ELEGANCE TSH ELISA. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Bioclone Australia Pty , Ltd. (Washington, US). The FDA issued a Cleared decision on December 18, 1990 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1690 - 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 Bioclone Australia Pty , Ltd. devices

FDA 510(k) Submission Details - K905099

510(k) Number K905099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1990
Decision Date December 18, 1990
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 88d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JLW Device Classification - Class 2, Special Controls

Product Code JLW Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1690
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 - JLW Radioimmunoassay, Thyroid-stimulating Hormone

All 203
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K905099.
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MICROZYME TSH ENZYME IMMUNOASSAY KIT
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PHARMACIA DELFIA NEONATAL HTSH KIT
K905710 · Pharmacia, Inc. · Feb 1991
AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008
K904666 · Amersham Corp. · Nov 1990
EZ-BEAD TSH ENZYME IMMUNOASSAY KIT
K903725 · Immunotech Corp. · Oct 1990
NOVAPATH TSH ENZYME IMMUNOASSAY
K903311 · Bio-Rad · Sep 1990