Cleared Traditional

K873303 - BINAX L.S. TSH IRMA TEST KIT

K873303 is the FDA 510(k) clearance for BINAX L.S. TSH IRMA TEST KIT by Binax, Inc.. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K873303 · Binax, Inc. · Chemistry device
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Oct 1987
Decision
45d
Days
Class 2
Risk

K873303 is an FDA 510(k) clearance for the BINAX L.S. TSH IRMA TEST KIT. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Binax, Inc. (S. Portland, US). The FDA issued a Cleared decision on October 2, 1987 after a review of 45 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 Binax, Inc. devices

Submission Details

510(k) Number K873303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1987
Decision Date October 02, 1987
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 88d · This submission: 45d
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 126
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K873303.
VENTREX COATED TUBE TSH
K883342 · Ventrex Laboratories, Inc. · Sep 1988
REAGENTS FOR TSH ASSAY
K881381 · Sclavo, Inc. · Jul 1988
ABBOTT IMX HTSH
K880086 · Abbott Laboratories · Apr 1988
IRMA-COUNT TSH RKTS1, RKTS2, RKTS5, RKTSX
K872305 · Diagnostic Products Corp. · Jul 1987
DELFIA (TM) HTSH KIT
K871644 · Lkb Instruments, Inc. · May 1987
IQ TSH IMMUNOASSAY
K870244 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1987