Cleared Traditional

K181777 - AggreGuide A-100 ADP (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181777 · Aggredyne, Inc. · Hematology device
Mar 2019
Decision
269d
Days
Class 2
Risk

K181777 is an FDA 510(k) clearance for the AggreGuide A-100 ADP. 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 March 29, 2019 after a review of 269 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5700 - 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.

Submission Details

510(k) Number K181777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2018
Decision Date March 29, 2019
Days to Decision 269 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 205d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.