Cleared Traditional

K905807 - HELENA THROMBOPLASTIN REAGENT WITH DILUENT

K905807 is an FDA 510(k) clearance for HELENA THROMBOPLASTIN REAGENT WITH DILUENT, 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 110-day FDA review.

K905807 · Helena Laboratories · Hematology device
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Apr 1991
Decision
110d
Days
Class 2
Risk

K905807 is an FDA 510(k) clearance for the HELENA THROMBOPLASTIN REAGENT WITH DILUENT. 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 16, 1991 after a review of 110 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Helena Laboratories devices

FDA 510(k) Submission Details - K905807

510(k) Number K905807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1990
Decision Date April 16, 1991
Days to Decision 110 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
3d faster than avg
Panel avg: 113d · This submission: 110d
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 K905807.
ACS ULTRA-2 THROMBOPLASTIN
K913250 · Analytical Control Systems, Inc. · Nov 1991
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, MODIFICATION
K905857 · Helena Laboratories · Feb 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