Cleared Traditional

K940310 - HELENA THROMBOPLASTIN-MI REAGENT

K940310 is the FDA 510(k) clearance for HELENA THROMBOPLASTIN-MI REAGENT by Helena Laboratories. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K940310 · Helena Laboratories · Hematology device
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Apr 1994
Decision
86d
Days
Class 2
Risk

K940310 is an FDA 510(k) clearance for the HELENA THROMBOPLASTIN-MI REAGENT. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on April 20, 1994 after a review of 86 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 K940310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1994
Decision Date April 20, 1994
Days to Decision 86 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 113d · This submission: 86d
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 K940310.
ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT
K935748 · Ortho Diagnostic Systems, Inc. · Apr 1995
DADE INNOVIN II
K935702 · Baxter Diagnostics, Inc. · Nov 1994
MICROCOAGULATION PROTHROMBIN TIME TEST
K940432 · International Technidyne Corp. · May 1994
ASSESS(TM) LOW ABNORMAL CONTROL
K931117 · Instrumentation Laboratory CO · Mar 1994
ASSESS(TM) HIGH ABNORMAL CONTROL
K931118 · Instrumentation Laboratory CO · Mar 1994
IL TEST (TM) PT-FIBRINOGEN HS PLUS
K933252 · Instrumentation Laboratory CO · Oct 1993