# K990398: Plateletworks

- Pathway: 510(k) (Traditional)
- Applicant: Array Medical, Inc.
- Decided: Dec 1, 1999 after 295 days
- Product code: JOZ (System, Automated Platelet Aggregation)
- Device class: 2
- Regulation: 21 CFR 864.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K771198 (1977). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K822733: Sigma Reagent System NO. 885, Sigma Chemical Co. (1982) Summary page 1.
- K832929: Ristocetin Platelet Aggrega-Reagent Test, Sigma Chemical Co. (1983) Summary page 1.
- K771198: Lumi-Aggregometer, Chrono-Log Corp. (1977) Summary page 2.
- K830749: Platelet Aggregometer, Chrono-Log Corp. (1983) Summary page 1.
- K851025: Aggro/Link Computer Interface, Chrono-Log Corp. (1985) Summary page 1.

## Most influential descendants
- K023761: Plateletworks, Models PW-a, PW-C (2003), 0 descendants of its own

## Indications for use
Plateletworks is an in vitro diagnostic screening assay for the determination of % platelet aggregation in fresh whole blood samples taken during cardiac interventional procedures as measured by a change in platelet count due to activation of functional platelets. It may be used at the point-of-care on the Ichor hematology analyzer as a screening tool for the detection of trends suggestive of platelet dysfunction. Any abnormal baseline or otherwise suspicious result would require repeating the Plateletworks test procedure and/or further additional investigation with more definitive test methods, including conventional platelet aggregometry.

Source page: https://510kreport.com/device/K990398
Methodology: https://510kreport.com/methodology