Cleared Traditional

K935049 - ELEGANCE NEONATAL TSH ELISA

K935049 is an FDA 510(k) clearance for ELEGANCE NEONATAL 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 348-day FDA review.

K935049 · Bioclone Australia Pty , Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
348d
Days
Class 2
Risk

K935049 is an FDA 510(k) clearance for the ELEGANCE NEONATAL 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 October 3, 1994 after a review of 348 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Bioclone Australia Pty , Ltd. devices

FDA 510(k) Submission Details - K935049

510(k) Number K935049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1993
Decision Date October 03, 1994
Days to Decision 348 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
260d slower than avg
Panel avg: 88d · This submission: 348d
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 K935049.
IMMULITE RAPID TSH
K933212 · Diagnostic Products Corp. · Dec 1994
RADIAS NEONATAL TSH ENZYME IMMUNOASSAY
K935399 · Bio-Rad · Dec 1994
IMMULITE THIRD GENERATION (MODIFICATION)
K940006 · Diagnostic Products Corp. · Dec 1994
DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM
K941146 · Dupont Medical Products · Oct 1994
IMX ULTRASENSISTIVE HTSH II
K942566 · Abbott Laboratories · Aug 1994
AXSYM ULTRASENSITIVE HTSH
K934410 · Abbott Laboratories · Jun 1994