Cleared Traditional

K921958 - ELISA TUBE TSH TEST

K921958 is an FDA 510(k) clearance for ELISA TUBE TSH TEST, manufactured by Bio Clinic Co.. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K921958 · Bio Clinic Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
66d
Days
Class 2
Risk

K921958 is an FDA 510(k) clearance for the ELISA TUBE TSH TEST. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Bio Clinic Co. (St. Louis, US). The FDA issued a Cleared decision on July 2, 1992 after a review of 66 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 Bio Clinic Co. devices

FDA 510(k) Submission Details - K921958

510(k) Number K921958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1992
Decision Date July 02, 1992
Days to Decision 66 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
22d faster than avg
Panel avg: 88d · This submission: 66d
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 203
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K921958.
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K922736 · Eastman Kodak Company · Jul 1992
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K921700 · Medix Biotech, Inc. · Jun 1992
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