Cleared Traditional

K801932 - HEP-TROL

K801932 is the FDA 510(k) clearance for HEP-TROL by Helena Laboratories. It is a Class 2 Hematology device (product code GGW) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K801932 · Helena Laboratories · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1980
Decision
28d
Days
Class 2
Risk

K801932 is an FDA 510(k) clearance for the HEP-TROL. Classified as Test, Time, Partial Thromboplastin (product code GGW), Class II - Special Controls.

Submitted by Helena Laboratories (Mchenry, US). The FDA issued a Cleared decision on September 9, 1980 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7925 - 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 K801932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1980
Decision Date September 09, 1980
Days to Decision 28 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
85d faster than avg
Panel avg: 113d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGW Test, Time, Partial Thromboplastin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7925
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 - GGW Test, Time, Partial Thromboplastin

All 20
Devices cleared under the same product code (GGW) and FDA review panel - the closest regulatory comparables to K801932.
ACUSCREEN
K822782 · Ortho Diagnostic Systems, Inc. · Oct 1982
ACTIN FS ACTIVATED PTT REAGENT
K811589 · American Dade · Jul 1981
AB-TROL COAGULATION CONTROL
K802232 · Helena Laboratories · Nov 1980
VERIFY S PROD. #34141
K800925 · General Diagnostics · Jul 1980
ANTIBODY TO VARICELLA-ZOSTER VIRUS
K800787 · Electro-Nucleonics Laboratories, Inc. · Jul 1980
A-GENT QUANTICHROM THROMBIGEN I
K800725 · Abbott Laboratories · Jun 1980