Cleared Traditional

K861918 - V-TREND EIA TSH

K861918 is an FDA 510(k) clearance for V-TREND EIA TSH, manufactured by V-Tech, Inc.. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K861918 · V-Tech, Inc. · Chemistry device
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Jul 1986
Decision
44d
Days
Class 2
Risk

K861918 is an FDA 510(k) clearance for the V-TREND EIA TSH. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by V-Tech, Inc. (Pomona, US). The FDA issued a Cleared decision on July 2, 1986 after a review of 44 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 V-Tech, Inc. devices

FDA 510(k) Submission Details - K861918

510(k) Number K861918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1986
Decision Date July 02, 1986
Days to Decision 44 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
44d faster than avg
Panel avg: 88d · This submission: 44d
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 200
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K861918.
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MICROMEDIC HTSH MONOCLONAL IRMA KIT
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TSH IRMA KIT
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TERUMO SENSIBEAD EIA TSH KIT
K861573 · Terumo Medical Corp. · Jun 1986
SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO.
K861920 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1986