Cleared Traditional

K883342 - VENTREX COATED TUBE TSH

K883342 is the FDA 510(k) clearance for VENTREX COATED TUBE TSH by Ventrex Laboratories, Inc.. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K883342 · Ventrex Laboratories, Inc. · Chemistry device
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Sep 1988
Decision
35d
Days
Class 2
Risk

K883342 is an FDA 510(k) clearance for the VENTREX COATED TUBE TSH. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Ventrex Laboratories, Inc. (Portland, US). The FDA issued a Cleared decision on September 13, 1988 after a review of 35 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 Ventrex Laboratories, Inc. devices

Submission Details

510(k) Number K883342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1988
Decision Date September 13, 1988
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 88d · This submission: 35d
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 K883342.
VENTREX COATED TUBE HIGH SENSITIVITY TSH
K885157 · Ventrex Laboratories, Inc. · Feb 1989
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REAGENTS FOR TSH ASSAY
K881381 · Sclavo, Inc. · Jul 1988
ABBOTT IMX HTSH
K880086 · Abbott Laboratories · Apr 1988
TSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1093
K874061 · Medix Biotech, Inc. · Nov 1987