Cleared Traditional

K905857 - HELENA THROMBOPLASTIN REAGENT

K905857 is the FDA 510(k) clearance for HELENA THROMBOPLASTIN REAGENT by Helena Laboratories. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K905857 · Helena Laboratories · Hematology device
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Feb 1991
Decision
75d
Days
Class 2
Risk

K905857 is an FDA 510(k) clearance for the HELENA THROMBOPLASTIN REAGENT, MODIFICATION. 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 February 27, 1991 after a review of 75 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 K905857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1990
Decision Date February 27, 1991
Days to Decision 75 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
38d faster than avg
Panel avg: 113d · This submission: 75d
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 K905857.
ACS LIQUID THROMBOPLASTIN
K912102 · Analytical Control Systems, Inc. · Aug 1991
PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION
K911995 · International Technidyne Corp. · Jul 1991
HELENA THROMBOPLASTIN REAGENT WITH DILUENT
K905807 · Helena Laboratories · Apr 1991
HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION
K904454 · International Technidyne Corp. · Dec 1990
ACS ONE-STAGE PROTHROMBIN TIME REAGENT
K902468 · Analytical Control Systems, Inc. · Aug 1990
THROMBOPLASTIN WITH CALCIUM
K902096 · Sigma Chemical Co. · Jul 1990