Cleared Traditional

K970393 - THYROID STIMULATING HORMONE METHOD

K970393 is an FDA 510(k) clearance for THYROID STIMULATING HORMONE METHOD, manufactured by Dade Chemistry Systems, Inc.. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K970393 · Dade Chemistry Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
28d
Days
Class 2
Risk

K970393 is an FDA 510(k) clearance for the THYROID STIMULATING HORMONE METHOD. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Dade Chemistry Systems, Inc. (Glasgow, US). The FDA issued a Cleared decision on March 3, 1997 after a review of 28 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 Dade Chemistry Systems, Inc. devices

FDA 510(k) Submission Details - K970393

510(k) Number K970393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1997
Decision Date March 03, 1997
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
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 188
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K970393.
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SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY)
K962464 · Scantibodies Laboratory, Inc. · Oct 1996
THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST
K961629 · Teco Diagnostics · Sep 1996