510(k) · Cleared
ClearedVerifynow-Aspirin Assay
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 Oct 6, 2004 as substantially equivalent to K830749 (Chrono-Log Corp., 1983) after a 29-day review. Its family tree reaches back 1 generation to 1983. 3 later devices descend from it.
- Decided
- Oct 6, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- JOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K830749 (1983). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK830749 Platelet AggregometerChrono-Log Corp. · 1983
- This deviceK042423 Verifynow-Aspirin AssayAccumetrics, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK122162 AggreguideAggredyne, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK163274 AggreGuide A-100 AA Assay, AggreGuide A-100 InstrumentAggredyne, Inc. · 2017 · Recalled
- Descendant · cites it directly · 0 of its ownK062025 Aspirinworks Test Kit (11-Dehydro Thromboxane B2), Model 12136Corgenix, Inc. · 2007
Most influential descendants
Showing 3 of 3 · See all- K122162AggreguideAggredyne, Inc. · 2013 · cites it directly1descendant
- K163274AggreGuide A-100 AA Assay, AggreGuide A-100 InstrumentAggredyne, Inc. · 2017 · 2 generations on0descendants
- K062025Aspirinworks Test Kit (11-Dehydro Thromboxane B2), Model 12136Corgenix, Inc. · 2007 · cites it directly0descendants
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) | K042423 | Verifynow-Aspirin Assay | Accumetrics, Inc. | 2004 | — |
| +1 | K122162 | Aggreguide | Aggredyne, Inc. | 2013 | 1 |
| +2 | K163274 | AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument | Aggredyne, Inc. | 2017 | 1 |
| +1 | K062025 | Aspirinworks Test Kit (11-Dehydro Thromboxane B2), Model 12136 | Corgenix, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
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 VerifyNow System is a turbidimetric based optical detection system which measures platelet induced agg… | 1983 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 VerifyNow Aspirin Assay is a qualitative assay to aid in the detection of platelet dysfunction due to aspirin ingestion in citrated whole blood for the point of care or laboratory setting.
This assay is not for use in patients with underlying congenital platelet abnormalities, patients with non-aspirin induced acquired platelet abnormalities or in patients receiving non-aspirin 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/K042423 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042423: Verifynow-Aspirin Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042423
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026