Cleared Traditional

K830331 - LIQUID THROMBOPLASTIN REAGENT

K830331 is an FDA 510(k) clearance for LIQUID THROMBOPLASTIN REAGENT, manufactured by Helena Laboratories. The device is a Class 2 Hematology device with product code GJS cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K830331 · Helena Laboratories · Hematology device
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Apr 1983
Decision
63d
Days
Class 2
Risk

K830331 is an FDA 510(k) clearance for the LIQUID THROMBOPLASTIN REAGENT. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Helena Laboratories (Mchenry, US). The FDA issued a Cleared decision on April 5, 1983 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7750 - the FDA hematology device 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 Helena Laboratories devices

FDA 510(k) Submission Details - K830331

510(k) Number K830331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1983
Decision Date April 05, 1983
Days to Decision 63 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 113d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GJS Device Classification - Class 2, Special Controls

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 Hematology devices follow this clearance model.

Regulatory Peers - GJS Test, Time, Prothrombin

All 113
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K830331.
ORTHO BRAIN THROMBOPLASTIN DILUENT
K843535 · Ortho Diagnostic Systems, Inc. · Dec 1984
DIA THROMBIN DIA PLASTIN
K840802 · Diatech, Inc. · May 1984
EASYTOUCH TROMBOPLASTIN REAGENT
K832427 · Worthington Diagnostic Systems · Oct 1983
SIGMA PROCEDURE #890
K811784 · Sigma Chemical Co. · Jul 1981
THROMBOPLASTIN
K810350 · Pacific Hemostasis · Apr 1981
LANCER COAGENT PT KIT
K792031 · Sherwood Medical Co. · Nov 1979