Cleared Traditional

K920856 - VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS

K920856 is an FDA 510(k) clearance for VENTREX COATED TUBE HIGH SENSIT. TSH RA..., manufactured by Hycor Biomedical, Inc.. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K920856 · Hycor Biomedical, Inc. · Chemistry device
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Mar 1992
Decision
37d
Days
Class 2
Risk

K920856 is an FDA 510(k) clearance for the VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Hycor Biomedical, Inc. (Portland, US). The FDA issued a Cleared decision on March 26, 1992 after a review of 37 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.

FDA 510(k) Submission Details - K920856

510(k) Number K920856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1992
Decision Date March 26, 1992
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 89d · This submission: 37d
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 238
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K920856.
ELISA TUBE TSH TEST
K921958 · Bio Clinic Co. · Jul 1992
TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093
K921700 · Medix Biotech, Inc. · Jun 1992
VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY
K921816 · Biomerieux Vitek, Inc. · Jun 1992
IMMUCHEM TSH-MW ELISA
K920442 · Icn Biomedicals, Inc. · Mar 1992
ENZYMUN-TEST TSH
K915195 · Boehringer Mannheim Corp. · Feb 1992
ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT
K914756 · Medix Biotech, Inc. · Jan 1992
K920856 · VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS
Download PDF Hycor Biomedical, Inc.