Cleared Traditional

K832427 - EASYTOUCH TROMBOPLASTIN REAGENT

K832427 is the FDA 510(k) clearance for EASYTOUCH TROMBOPLASTIN REAGENT by Worthington Diagnostic Systems. It is a Class 2 Chemistry device (product code GJS) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K832427 · Worthington Diagnostic Systems · Chemistry device
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Oct 1983
Decision
84d
Days
Class 2
Risk

K832427 is an FDA 510(k) clearance for the EASYTOUCH TROMBOPLASTIN REAGENT. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Worthington Diagnostic Systems (Mchenry, US). The FDA issued a Cleared decision on October 14, 1983 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7750 - 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 Worthington Diagnostic Systems devices

Submission Details

510(k) Number K832427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1983
Decision Date October 14, 1983
Days to Decision 84 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 88d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GJS Test, Time, Prothrombin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7750
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 - GJS Test, Time, Prothrombin

All 101
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K832427.
PLASTINEX
K852484 · Bio/Data Corp. · Aug 1985
ACA PROTHROMBIN TIME ANALYTICAL TEST PACK
K851125 · E.I. Dupont DE Nemours & Co., Inc. · May 1985
ORTHO BRAIN THROMBOPLASTIN DILUENT
K843535 · Ortho Diagnostic Systems, Inc. · Dec 1984
LIQUID THROMBOPLASTIN REAGENT
K830331 · Helena Laboratories · Apr 1983
SIGMA PROCEDURE #890
K811784 · Sigma Chemical Co. · Jul 1981
THROMBOPLASTIN
K810350 · Pacific Hemostasis · Apr 1981