Cleared Traditional

PLATELETWORKS (K990398) - FDA 510(k) Clearance

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

K990398 · Array Medical, Inc. · Hematology device
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Dec 1999
Decision
295d
Days
Class 2
Risk

K990398 is an FDA 510(k) clearance for the PLATELETWORKS. Classified as System, Automated Platelet Aggregation (product code JOZ), Class II - Special Controls.

Submitted by Array Medical, Inc. (Somerville, US). The FDA issued a Cleared decision on December 1, 1999 after a review of 295 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.

View all Array Medical, Inc. devices

Submission Details

510(k) Number K990398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1999
Decision Date December 01, 1999
Days to Decision 295 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
182d slower than avg
Panel avg: 113d · This submission: 295d
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.

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 K990398.
T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01
K191364 · Fujimori Kogyo, Co., Ltd. · Feb 2020
AggreGuide A-100 ADP
K181777 · Aggredyne, Inc. · Mar 2019
DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS
K060489 · Dade Behring, Inc. · Jul 2006
PLATELETWORKS, MODELS PW-A, PW-C
K023761 · Helena Laboratories · Feb 2003
PLATELETWORKS
K012723 · Helena Laboratories · Sep 2001
DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP
K002885 · Dade Behring, Inc. · Jun 2001