# K012701: Ultegra System Rapid Platelet Function Assay - Asa (Rpfa-Asa)

- Pathway: 510(k) (Traditional)
- Applicant: Accumetrics, Inc.
- Decided: Jun 12, 2002 after 302 days
- Product code: JOZ (System, Automated Platelet Aggregation)
- Device class: 2
- Regulation: 21 CFR 864.5700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K830749 (1983). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K830749: Platelet Aggregometer, Chrono-Log Corp. (1983) Summary page 1.

## Recalls of this device
- May 10, 2004 · Not classified · Z-1018-04: Test results too low in control.

## Indications for use
The Ultegra® Rapid Platelet Function Assay-ASA (RPFA-ASA) is a whole blood assay used to measure platelet response to aspirin. The Ultegra Rapid Platelet Function Assay-ASA (RPFA-ASA) is a qualitative test to aid in the detection of platelet dysfunction due to aspirin (ASA) ingestion in citrated whole blood for the point of care or laboratory setting. Not for use in patients with underlying congenital platelet abnormalities, patients with non-ASA induced acquired platelet abnormalities or in patients receiving non-ASA anti-platelet agents (may be used in patients treated with selective COX-2 inhibitors, e.g., celecoxib (Celebrex®) and rofecoxib (Vioxx®)).

Source page: https://510kreport.com/device/K012701
Methodology: https://510kreport.com/methodology