Cleared Special

K163274 - AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument

K163274 is an FDA 510(k) clearance for AggreGuide A-100 AA Assay, manufactured by Aggredyne, Inc.. The device is a Class 2 Hematology device with product code JOZ cleared through the Special 510(k) pathway after a 135-day FDA review.

K163274 · Aggredyne, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K163274

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 113d · This submission: 135d
Pathway characteristics
Modification to existing cleared device.

JOZ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - JOZ System, Automated Platelet Aggregation

All 37
Devices cleared under the same product code (JOZ) and FDA review panel - the closest regulatory comparables to K163274.
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K122162 · Aggredyne, Inc. · Dec 2013
K163274 · AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument
Download PDF FDA Summary Aggredyne, Inc.