# K970505: Dade Pfa-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine Test Cartridge/Pfa Collagen/Adp Test Cartridge/

- Pathway: 510(k) (Traditional)
- Applicant: Dade Intl., Inc.
- Decided: Nov 17, 1997 after 280 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). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K771198: Lumi-Aggregometer, Chrono-Log Corp. (1977) Summary page 1.
- 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
- K060489: Dade Pfa-100 Platelet Function Analyzer and Reagents (2006), 1 descendant of its own
- K191364: 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 (2020), 0 descendants of its own

## Indications for use
To aid in the detection of platelet dysfunction in citrated human whole blood for use in patients with a suspected disorder of primary hemostasis.

Source page: https://510kreport.com/device/K970505
Methodology: https://510kreport.com/methodology