Cleared Traditional

K905807 - HELENA THROMBOPLASTIN REAGENT WITH DILUENT

K905807 is the FDA 510(k) clearance for HELENA THROMBOPLASTIN REAGENT WITH DILUENT by Helena Laboratories. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K905807 · Helena Laboratories · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 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