Cleared Special

K163274 - AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument (FDA 510(k) Clearance)

Class II Hematology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K163274 · Aggredyne, Inc. · Hematology device
Apr 2017
Decision
135d
Days
Class 2
Risk

K163274 is an FDA 510(k) clearance for the AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument. Classified as System, Automated Platelet Aggregation (product code JOZ), Class II - Special Controls.

Submitted by Aggredyne, Inc. (Houston, US). The FDA issued a Cleared decision on April 5, 2017 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5700 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K163274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2016
Decision Date April 05, 2017
Days to Decision 135 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 205d · This submission: 135d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JOZ System, Automated Platelet Aggregation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5700
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.