510(k) · Cleared
Recalled · Class II · 2012Verifynow-P2Y12 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 Aug 5, 2005 as substantially equivalent to K830749 (Chrono-Log Corp., 1983) after an 84-day review. Its family tree reaches back 1 generation to 1983. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Aug 5, 2005
- Review
- 84 days
- Class
- Class II
- Product code
- JOZ
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K830749 (1983). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK830749 Platelet AggregometerChrono-Log Corp. · 1983
- This deviceK051231 Verifynow-P2Y12 AssayAccumetrics, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK141427 Accumetrics,Inc. Verifynow Prutest, Accumetrics, Inc. Verifynow…Accumetrics, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 0 of its ownK181777 AggreGuide A-100 ADPAggredyne, Inc. · 2019 · Recalled
Most influential descendants
Showing 2 of 2 · See allView 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) | K051231 | Verifynow-P2Y12 Assay | Accumetrics, Inc. | 2005 | — |
| +1 | K141427 | Accumetrics,Inc. Verifynow Prutest, Accumetrics, Inc. Verifynow Prutest | Accumetrics, Inc. | 2015 | 2 |
| +2 | K181777 | AggreGuide A-100 ADP | Aggredyne, Inc. | 2019 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 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…ces, specifically the CHRONO-LOG Whole Blood Aggregometer with CHRONO-PAR®ADP Reagent, as the predicate device. The CHRONO-LOG Whole Blood Aggregometer was cleared under k830749. Device Description: The VerifyNow System is a turbidimetric based optical detection system, which measures platelet induced aggr… | 1983 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141427 | Accumetrics,Inc. Verifynow Prutest, Accumetrics, Inc. Verifynow Prutest | 2015 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 6, 2012 | Class II | Z-1854-2012 | No Marketing Application | The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Test reports three values: PRU, BASE and… |
| Feb 6, 2012 | Class II | Z-1853-2012 | No Marketing Application | The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Test reports three values: PRU, BASE and… |
| Sep 5, 2006 | Not classified | Z-0228-2007 | Other | The VerifyNow P2Y12 assay can report an erroneous result instead of an error message when a sample with low hematocrit is run. |
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-P2Y1 2 Assay is a whole blood assay used in the laboratory or
point of care setting to measure the level of platelet P2Y1 2 receptor blockade.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051231: Verifynow-P2Y12 Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051231
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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