Cleared Traditional

K914756 - ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUN...

K914756 is the FDA 510(k) clearance for ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUN... by Medix Biotech, Inc.. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K914756 · Medix Biotech, Inc. · Chemistry device
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Jan 1992
Decision
85d
Days
Class 2
Risk

K914756 is an FDA 510(k) clearance for the ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Medix Biotech, Inc. (Foster City, US). The FDA issued a Cleared decision on January 15, 1992 after a review of 85 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 Medix Biotech, Inc. devices

Submission Details

510(k) Number K914756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1991
Decision Date January 15, 1992
Days to Decision 85 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
3d faster than avg
Panel avg: 88d · This submission: 85d
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 145
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K914756.
VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY
K921816 · Biomerieux Vitek, Inc. · Jun 1992
VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS
K920856 · Hycor Biomedical, Inc. · Mar 1992
ENZYMUN-TEST TSH
K915195 · Boehringer Mannheim Corp. · Feb 1992
STRATUS(R) ULTRA-SENSIT HTSH FLUOR ENZYME IMMUNO
K912852 · Baxter Healthcare Corp · Sep 1991
MAGIC LITE TSH (HS) IMMUNOASSAY
K912583 · Ciba Corning Diagnostics Corp. · Aug 1991
STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY
K912241 · Baxter Healthcare Corp · Jun 1991