510(k) · Cleared
Recalled · Class II · 2019AggreGuide A-100 ADP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aggredyne, Inc. · JOZ System, Automated Platelet Aggregation
Cleared on Mar 29, 2019 as substantially equivalent to K141427 (Accumetrics, Inc., 2015) after a 269-day review. Its family tree reaches back 3 generations to 1983. It has been recalled once.
- Decided
- Mar 29, 2019
- Review
- 269 days
- Class
- Class II
- Product code
- JOZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K830749 (1983). No later device cites it as a predicate yet.
- Root · 3 generations backK830749 Platelet AggregometerChrono-Log Corp. · 1983
- 2 generations backK051231 Verifynow-P2Y12 AssayAccumetrics, Inc. · 2005 · Recalled
- 1 generation backK141427 Accumetrics,Inc. Verifynow Prutest, Accumetrics, Inc. Verifynow…Accumetrics, Inc. · 2015 · Recalled
- This deviceK181777 AggreGuide A-100 ADPAggredyne, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K830749 | Platelet Aggregometer | Chrono-Log Corp. | 1983 | — |
| −2 | K051231 | Verifynow-P2Y12 Assay | Accumetrics, Inc. | 2005 | 3 |
| −1 | K141427 | Accumetrics,Inc. Verifynow Prutest, Accumetrics, Inc. Verifynow Prutest | Accumetrics, Inc. | 2015 | 2 |
| 0 (this device) | K181777 | AggreGuide A-100 ADP | Aggredyne, Inc. | 2019 | — |
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 |
|---|---|---|---|
| * | K141427 | Accumetrics,Inc. Verifynow Prutest, Accumetrics, Inc. Verifynow PrutestSummary page 4…Product Code: JOZ Class II 3. Predicate Devices: The predicate is: VerifyNow-P2Y12 Assay [K141427] 510(K) AggreGuide A-100 ADP Assay Page 1 K181777 4. Description of… | 2015 |
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 |
|---|---|---|---|---|
| Jul 23, 2019 | Class II | Z-1639-2022 | Software design | The firm identified a software design issue where the improper shut down of the instrument resulted in speeds.csv file contents of the software version 5.1 being erased. Due to this issue, the target RPM for the assay is 0 and the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 3 companies; a new generation was cleared every 10.0 years on median.
- 2 of the 3 ancestors have a recall of any class.
How does its category compare?
All JOZ devicesJOZ System, Automated Platelet Aggregation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 AggreGuide A-100 ADP Assay is used with the AggreGuide A-100 instrument in non-CLIA waived physician’s office or clinical laboratory for the detection of platelet dysfunction in patients age 22 or older receiving P2Y 12 antiplatelet drugs, prasugrel and ticagrelor, using 3.2% sodium citrated whole blood. The AggreGuide A-100 ADP Assay is a semi-quantitative assay. The level of platelet aggregation is determined by the platelet activity index (PAI)…
Read the full statement (109 words)
The AggreGuide A-100 ADP Assay is used with the AggreGuide A-100 instrument in non-CLIA waived physician’s office or clinical laboratory for the detection of platelet dysfunction in patients age 22 or older receiving P2Y 12 antiplatelet drugs, prasugrel and ticagrelor, using 3.2% sodium citrated whole blood. The AggreGuide A-100 ADP Assay is a semi-quantitative assay. The level of platelet aggregation is determined by the platelet activity index (PAI) where values < 4.7 PAI suggest that platelet dysfunction is due to the presence of P2Y 12 antiplatelet drugs, prasugrel and ticagrelor. The test results should be interpreted in conjunction with all other clinical and laboratory data available to the clinician.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181777 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181777: AggreGuide A-100 ADP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181777
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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