Cleared Traditional

K030912 - THYRO TEST

K030912 is an FDA 510(k) clearance for THYRO TEST, manufactured by Thryotec. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K030912 · Thryotec · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
123d
Days
Class 2
Risk

K030912 is an FDA 510(k) clearance for the THYRO TEST. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Thryotec (Beverly, US). The FDA issued a Cleared decision on July 25, 2003 after a review of 123 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Thryotec devices

FDA 510(k) Submission Details - K030912

510(k) Number K030912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2003
Decision Date July 25, 2003
Days to Decision 123 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
35d slower than avg
Panel avg: 88d · This submission: 123d
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 199
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K030912.
DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE
K060090 · Dade Behring, Inc. · Feb 2006
MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY
K042281 · Beckman Coulter, Inc. · Sep 2004
TSH-CTK-3 IRMA
K041014 · DiaSorin, Inc. · Jul 2004
ACCESS HYPERSENSITIVE HTSH ASSAY
K023093 · Beckman Coulter, Inc. · Nov 2002
CHEMWELL, ALSO KNOWN AS PROJECT 2900
K013420 · Awareness Technology, Inc. · Jul 2002
ACCUWELL TSH, MODEL KAW-TSH-960
K001455 · Neometrics, Inc. · Nov 2000