Cleared Traditional

K990398 - PLATELETWORKS

K990398 is an FDA 510(k) clearance for PLATELETWORKS, manufactured by Array Medical, Inc.. The device is a Class 2 Hematology device with product code JOZ cleared through the Traditional 510(k) pathway after a 295-day FDA review.

K990398 · Array Medical, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K990398

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
Combination Product No
PCCP Authorized No
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.

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 30
Devices cleared under the same product code (JOZ) and FDA review panel - the closest regulatory comparables to K990398.
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
ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM
K992531 · Accumetrics, Inc. · Dec 1999
DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/
K970505 · Dade Intl., Inc. · Nov 1997
CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592
K962426 · Chrono-Log Corp. · Oct 1996
CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT
K954997 · Centocor, Inc. · Jan 1996