Cleared Special

K061014 - ACTALYKE QC KIT

K061014 is the FDA 510(k) clearance for ACTALYKE QC KIT by Helena Laboratories. It is a Class 2 Hematology device (product code JPA) cleared through the Special 510(k) pathway after a 27-day FDA review.

K061014 · Helena Laboratories · Hematology device
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May 2006
Decision
27d
Days
Class 2
Risk

K061014 is an FDA 510(k) clearance for the ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on May 10, 2006 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Helena Laboratories devices

Submission Details

510(k) Number K061014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2006
Decision Date May 10, 2006
Days to Decision 27 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 113d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - JPA System, Multipurpose For In Vitro Coagulation Studies

All 116
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K061014.
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HEMORAM/AGGRAM ANALYZER
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