Cleared Traditional

K892050 - HELENA THROMBOPLASTIN REAGENT

K892050 is an FDA 510(k) clearance for HELENA THROMBOPLASTIN REAGENT, 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 70-day FDA review.

K892050 · Helena Laboratories · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1989
Decision
70d
Days
Class 2
Risk

K892050 is an FDA 510(k) clearance for the HELENA THROMBOPLASTIN 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 June 7, 1989 after a review of 70 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

FDA 510(k) Submission Details - K892050

510(k) Number K892050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1989
Decision Date June 07, 1989
Days to Decision 70 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
43d faster than avg
Panel avg: 113d · This submission: 70d
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 K892050.
THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER.
K896625 · Medical Diagnostic Technologies, Inc. · Dec 1989
THROMBOSTIN IFA*
K885107 · Investigacion Farmaceutica S.A. DE C.V. · Jun 1989
PROTHROMBIN TIME (PT) BY HEMOCHRON
K893378 · International Technidyne Corp. · Jun 1989
DADE THROMBOPLASTIN IS
K891169 · Baxter Healthcare Corp · Apr 1989
THROMBOPLASTIN
K884855 · Precision Biologicals, Inc. · Jan 1989
VISION(R) PROTHROMBIN TIME
K883441 · Abbott Laboratories · Sep 1988