Cleared Traditional

ACTIVAT-PARTIAL THROMBO-PLASTIN (K830320) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K830320 · Helena Laboratories · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1983
Decision
64d
Days
Class 2
Risk

K830320 is an FDA 510(k) clearance for the ACTIVAT-PARTIAL THROMBO-PLASTIN. 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 April 5, 1983 after a review of 64 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 K830320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1983
Decision Date April 05, 1983
Days to Decision 64 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
49d faster than avg
Panel avg: 113d · This submission: 64d
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 31
Devices cleared under the same product code (GGW) and FDA review panel - the closest regulatory comparables to K830320.
HemosIL Factor V Leiden (APC Resistance V)
K260551 · Instrumentation Laboratory (IL) Co. · Mar 2026
ACA ACTIVATED PARTIAL THROMBOPLASTIN TIME ANALYTIC
K851126 · E.I. Dupont DE Nemours & Co., Inc. · May 1985
AB-TROL COAGULATION CONTROL
K802232 · Helena Laboratories · Nov 1980
HEP-TROL
K801932 · Helena Laboratories · Sep 1980
A-GENT QUANTICHROM THROMBIGEN I
K800725 · Abbott Laboratories · Jun 1980