Cleared Traditional

K052124 - ACTICLOT

K052124 is the FDA 510(k) clearance for ACTICLOT by American Diagnostica, Inc.. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K052124 · American Diagnostica, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
Oct 2005
Decision
73d
Days
Class 2
Risk

K052124 is an FDA 510(k) clearance for the ACTICLOT, MODEL 824. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by American Diagnostica, Inc. (Stamford, US). The FDA issued a Cleared decision on October 17, 2005 after a review of 73 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 American Diagnostica, Inc. devices

Submission Details

510(k) Number K052124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2005
Decision Date October 17, 2005
Days to Decision 73 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 113d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 95
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K052124.
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K021190 · Roche Diagnostics Corp. · Oct 2002