# K011337: Ultegra System Rapid Platelet Function Assay (Rpfa)

- Pathway: 510(k) (Traditional)
- Applicant: Accumetrics, Inc.
- Decided: Oct 16, 2001 after 167 days
- Product code: JOZ (System, Automated Platelet Aggregation)
- Device class: 2
- Regulation: 21 CFR 864.5700
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Feb 13, 2014 · Class II · Z-1172-2014: Accumetrics is recalling the VerifyNow IIb/IIIa test because it may result in the reporting of an erroneous low platelet aggregation unit (PAU) result. An erroneous low PAU result may cause a low perc
- Nov 14, 2013 · Class II · Z-0482-2014: Accumetrics is recalling the VerifyNow IIb/IIIa 10-Test because it contains incorrect information for the amount of time in which to perform the test following collection of the patient sample. The co

Source page: https://510kreport.com/device/K011337
Methodology: https://510kreport.com/methodology