510(k) · Cleared
ClearedACL AcuStar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on Mar 3, 2017 as substantially equivalent to K083518 (Instrumentation Laboratory CO, 2009) after a 30-day review. Its family tree reaches back 6 generations to 1986.
- Decided
- Mar 3, 2017
- Review
- 30 days
- Class
- Class II
- Product code
- JPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K862156 (1986). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK862156 Asserachrom D-DI KitAmerican Bioproducts Co. · 1986
- 5 generations backK973819 Vidas D-Dimer (DD) AssayBiomerieux Vitek, Inc. · 1998
- 4 generations backK020810 Vidas D-Dimer New (DD2) Assay Model#30 442bioMerieux, Inc. · 2002
- 3 generations backK040882 Vidas D-Dimer Exclusion Assay, Model 30 442bioMerieux, Inc. · 2004
- 2 generations backK070927 Hemosil D-Dimer HSInstrumentation Laboratory CO · 2007
- 1 generation backK083518 Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer ControlsInstrumentation Laboratory CO · 2009
- This deviceK170314 ACL AcuStarInstrumentation Laboratory CO · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K862156 | Asserachrom D-DI Kit | American Bioproducts Co. | 1986 | — |
| −5 | K973819 | Vidas D-Dimer (DD) Assay | Biomerieux Vitek, Inc. | 1998 | — |
| −4 | K020810 | Vidas D-Dimer New (DD2) Assay Model#30 442 | bioMerieux, Inc. | 2002 | — |
| −3 | K040882 | Vidas D-Dimer Exclusion Assay, Model 30 442 | bioMerieux, Inc. | 2004 | — |
| −2 | K070927 | Hemosil D-Dimer HS | Instrumentation Laboratory CO | 2007 | — |
| −1 | K083518 | Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer Controls | Instrumentation Laboratory CO | 2009 | — |
| 0 (this device) | K170314 | ACL AcuStar | Instrumentation Laboratory CO | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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 JPA? 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 JPA device
- #1 K243858 TEG 6s Hemostasis System Citrated: K, KH, RT…score 12.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K083518 | Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer ControlsSummary page 4…Panel: Hematology (81) Product Code: JPA Predicate Device ACL AcuStar: K083518 Indications for Use / The ACL AcuStar is an automated immunoassay analyzer designed Intended Use… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 31 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 3 of the 13 ancestors have a recall of any class.
- 1 other device also cites its predicate K083518.
How does its category compare?
All JPA devicesJPA System, Multipurpose For In Vitro Coagulation Studies: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · JPA
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JPA
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JPA
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JPA
11in 2025
MAUDE reports naming product code JPA, 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 | 1 | — | 1 | 1,744 |
| 2008 | 2 | — | 0 | 918 |
| 2009 | 6 | 91 | 0 | 1,363 |
| 2010 | 1 | — | 6 | 727 |
| 2011 | 1 | — | 4 | 161 |
| 2012 | 0 | — | 1 | 52 |
| 2013 | 1 | — | 0 | 43 |
| 2014 | 0 | — | 0 | 48 |
| 2015 | 2 | — | 0 | 45 |
| 2016 | 6 | 114 | 3 | 6 |
| 2017 | 4 | 117 | 0 | 15 |
| 2018 | 1 | — | 0 | 39 |
| 2019 | 3 | 175 | 0 | 27 |
| 2020 | 0 | — | 1 | 18 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 1 | — | 0 | 9 |
| 2023 | 3 | 506 | 0 | 11 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 3 | 30 | 0 | 11 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Automated immunoassay analyzer designed specifically for in vitro diagnostic use in a clinical laboratory. The assay analysis is based on chemiluminescent technology. The system provides results for both direct measurements and calculated parameters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170314 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170314: ACL AcuStar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170314
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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