510(k) · Cleared
Recalled · Class II · 2025Accumetrics,Inc. Verifynow Prutest, Accumetrics, Inc. Verifynow Prutest
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 Jul 24, 2015 as substantially equivalent to K051231 (Accumetrics, Inc., 2005) after a 420-day review. Its family tree reaches back 2 generations to 1983. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jul 24, 2015
- Review
- 420 days
- Class
- Class II
- Product code
- JOZ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K830749 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK830749 Platelet AggregometerChrono-Log Corp. · 1983
- 1 generation backK051231 Verifynow-P2Y12 AssayAccumetrics, Inc. · 2005 · Recalled
- This deviceK141427 Accumetrics,Inc. Verifynow Prutest, Accumetrics, Inc. Verifynow…Accumetrics, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK181777 AggreGuide A-100 ADPAggredyne, Inc. · 2019 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K181777AggreGuide A-100 ADPAggredyne, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K830749 | Platelet Aggregometer | Chrono-Log Corp. | 1983 | — |
| −1 | K051231 | Verifynow-P2Y12 Assay | Accumetrics, Inc. | 2005 | 3 |
| 0 (this device) | K141427 | Accumetrics,Inc. Verifynow Prutest, Accumetrics, Inc. Verifynow Prutest | Accumetrics, Inc. | 2015 | — |
| +1 | K181777 | AggreGuide A-100 ADP | Aggredyne, Inc. | 2019 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K051231 | Verifynow-P2Y12 AssaySummary page 4…n name: Automated platelet aggregation system (21 CFR §864.5700; Product Code: JOZ) Predicate device: VerifyNow P2Y12 Assay, Accumetrics, Inc., k051231 Device description: The VerifyNow System is a turbidimetric-based optical detection system that measures platelet- induced aggr… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181777 | AggreGuide A-100 ADP | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 21, 2025 | Class III | Z-0500-2026 | Under Investigation by firm | Due to an device without a premarket clearance being incorrectly package and distributed. |
| Mar 30, 2022 | Class II | Z-1121-2022 | Employee error | Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are used to obtain P2Y12 Reactivity Unit results. The test without US-FDA market clearance was distributed and it displays BASE results not… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 2 companies; a new generation was cleared every 22.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K181777 (Aggredyne, Inc., 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JOZ devicesJOZ System, Automated Platelet Aggregation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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 PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. For in vitro diagnostic use. For professional use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141427 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141427: Accumetrics,Inc. Verifynow Prutest, Accumetrics, Inc. Verifynow Prutest.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141427
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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