Cleared Traditional

K830331 - LIQUID THROMBOPLASTIN REAGENT

K830331 is the FDA 510(k) clearance for LIQUID THROMBOPLASTIN REAGENT by Helena Laboratories. It is a Class 2 Hematology device (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

Submission Details

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.

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 Hematology devices follow this clearance model.

Regulatory Peers - GJS Test, Time, Prothrombin

All 94
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K830331.
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
SIGMA PROCEDURE #890
K811784 · Sigma Chemical Co. · Jul 1981
LANCER COAGENT PT KIT
K792031 · Sherwood Medical Co. · Nov 1979
THROMBOPLASTIN DRIED
K780203 · Hyland Therapeutic Div., Travenol Laboratories · Mar 1978