# K060489: Dade Pfa-100 Platelet Function Analyzer and Reagents

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jul 21, 2006 after 147 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: 2 generations 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)
- K970505: Dade Pfa-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine Test Cartridge/Pfa Collagen/Adp Test Cartridge/, Dade Intl., Inc. (1997) Summary page 1.
- K002885: Dade Pfa-100 Platelet Function Analyzer Model-100, Dade Pfa Collegen/Epinephrine Test Cartride, Dade Pfa Colleagen /Adp, Dade Behring, Inc. (2001) Summary page 1.

## Most influential descendants
- 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.

Source page: https://510kreport.com/device/K060489
Methodology: https://510kreport.com/methodology