# K992531: Ultegra System Analyzer, Ultegra System Rpfa-Trap Test Cartidges, Ultegra System Rpfa-Trap Level One QC, Ultegra System

- Pathway: 510(k) (Traditional)
- Applicant: Accumetrics, Inc.
- Decided: Dec 20, 1999 after 145 days
- Product code: JOZ (System, Automated Platelet Aggregation)
- Device class: 2
- Regulation: 21 CFR 864.5700
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K760198 (1976). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.
- K760198: Kit, Platelet Aggregation Reagent (#390), Chrono-Log Corp. (1976) Summary page 1.

## 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
- Sep 13, 2005 · Not classified · Z-0102-06: In 2001, separate reports of mild shock, sparking and smoke from Accumetrics PN 29001 power supply.

## Indications for use
The Ultegra Rapid Platelet Function Assay (RPFA) is a semi-quantitative, whole blood platelet function assay used to measure glycoprotein (GP) IIb/IIIa receptor blockade in patients treated with abciximab. Ultegra RPFA results should be interpreted in conjunction with other clinical and laboratory data available to the clinician.

Source page: https://510kreport.com/device/K992531
Methodology: https://510kreport.com/methodology