Cleared Traditional

K971780 - THYROTROPIN(TSH) ELISA

K971780 is the FDA 510(k) clearance for THYROTROPIN(TSH) ELISA by Monobind. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K971780 · Monobind · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
41d
Days
Class 2
Risk

K971780 is an FDA 510(k) clearance for the THYROTROPIN(TSH) ELISA. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Monobind (Costa Mesa, US). The FDA issued a Cleared decision on June 24, 1997 after a review of 41 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 Monobind devices

Submission Details

510(k) Number K971780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1997
Decision Date June 24, 1997
Days to Decision 41 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
47d faster than avg
Panel avg: 88d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 148
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K971780.
3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K981312 · Bayer Corp. · Jun 1998
ABBOTT AXSYM 3RD GENERATION TSH ASSAY
K981060 · Abbott Laboratories · Apr 1998
AIA-PACK TSH 3RD-GEN ASSAY
K972586 · Tosoh Medics, Inc. · Aug 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001)
K964558 · Johnson & Johnson Clinical Diagnostics, Inc. · Dec 1996
THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST
K961629 · Teco Diagnostics · Sep 1996
ELECSYS TSH ASSAY
K961491 · Boehringer Mannheim Corp. · Jul 1996