Cleared Traditional

K013078 - ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752

K013078 is an FDA 510(k) clearance for ACTALYKE MINI ACTIVATED CLOTTING TIME T..., manufactured by Helena Laboratories. The device is a Class 2 Hematology device with product code JBP cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K013078 · Helena Laboratories · Hematology device
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Jan 2002
Decision
118d
Days
Class 2
Risk

K013078 is an FDA 510(k) clearance for the ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752. Classified as Activated Whole Blood Clotting Time (product code JBP), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on January 10, 2002 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7140 - 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 - K013078

510(k) Number K013078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2001
Decision Date January 10, 2002
Days to Decision 118 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 113d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JBP Device Classification - Class 2, Special Controls

Product Code JBP Activated Whole Blood Clotting Time
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7140
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 - JBP Activated Whole Blood Clotting Time

All 14
Devices cleared under the same product code (JBP) and FDA review panel - the closest regulatory comparables to K013078.
Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer
K223635 · Sienco, Inc. · Jan 2023
ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770
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(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT
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I-STAT SYSTEM
K992571 · I-Stat Corp. · Feb 2000
ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM
K992851 · Roche Diagnostics Corp. · Jan 2000
GBACT + KIT
K984141 · Sienco, Inc. · May 1999