510(k) · Cleared
Recalled · 2004Ultegra System Rapid Platelet Function Assay - Asa (Rpfa-Asa)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accumetrics, Inc. · JOZ System, Automated Platelet Aggregation
Cleared on Jun 12, 2002 as substantially equivalent to K830749 (Chrono-Log Corp., 1983) after a 302-day review. Its family tree reaches back 1 generation to 1983. It has been recalled once.
- Decided
- Jun 12, 2002
- Review
- 302 days
- Class
- Class II
- Product code
- JOZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K830749 (1983). No later device cites it as a predicate yet.
- Root · 1 generation backK830749 Platelet AggregometerChrono-Log Corp. · 1983
- This deviceK012701 Ultegra System Rapid Platelet Function Assay - Asa (Rpfa-Asa)Accumetrics, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K830749 | Platelet Aggregometer | Chrono-Log Corp. | 1983 | — |
| 0 (this device) | K012701 | Ultegra System Rapid Platelet Function Assay - Asa (Rpfa-Asa) | Accumetrics, Inc. | 2002 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JOZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JOZ device
- #1 K191364 T-TAS 01 Total Thrombus-formation Analysis…score -0.6 · 3 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K830749 | Platelet AggregometerSummary page 1…en found to be substantially equivalent to previously cleared, automated platelet aggregation devices, specifically to CHRONO-LOG Corporation's Whole Blood Aggregometer (K830749). Device Description: The UZkgru System is a turbidimetric based optical detection system which measures platelet induced aggre… | 1983 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 10, 2004 | Not classified | Z-1018-04 | Other | Test results too low in control. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 8 other devices also cite its predicate K830749.
How does its category compare?
All JOZ devicesJOZ System, Automated Platelet Aggregation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JOZ
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · JOZ
Too few JOZ 510(k)s in any year since 2007 to give a median.
Recalls per year · JOZ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOZ
3in 2025
MAUDE reports naming product code JOZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 1 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 25 |
| 2019 | 1 | — | 0 | 9 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 1 | 1 |
| 2025 | 0 | — | 1 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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®)).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K012701 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012701: Ultegra System Rapid Platelet Function Assay - Asa (Rpfa-Asa).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012701
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026