510(k) Report

510(k) · Cleared

Cleared

Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer Controls

K083518510(k) TraditionalCleared Mar 13, 2009107-day reviewClass II21 CFR 864.5425

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Instrumentation Laboratory CO · JPA System, Multipurpose For In Vitro Coagulation Studies

Cleared on Mar 13, 2009 as substantially equivalent to K891385 (Vitek Systems, Inc., 1989) and 4 other predicates after a 107-day review. Its family tree reaches back 5 generations to 1986. 2 later devices descend from it.

Decided
Mar 13, 2009
Review
107 days
Class
Class II
Product code
JPA
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K862156 (1986). 12 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor1997: 1 other ancestor1989: 1 other ancestor2007: 1 other ancestor1995: 1 other ancestor2004: 1 other ancestor2000: 1 other ancestor2017: 1 descendant cleared2023: 1 descendant clearedK862156 · Asserachrom D-DI Kit · American Bioproducts Co. · 1986K973819 · Vidas D-Dimer (DD) Assay · Biomerieux Vitek, Inc. · 1998K020810 · Vidas D-Dimer New (DD2) Assay Model#30 442 · bioMerieux, Inc. · 2002K040882 · Vidas D-Dimer Exclusion Assay, Model 30 442 · bioMerieux, Inc. · 2004K070927 · Hemosil D-Dimer HS · Instrumentation Laboratory CO · 20071990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors3 generations back: 1 other ancestor4 generations back: 1 other ancestor 1 generation forward: 2 descendants K070927 · Hemosil D-Dimer HS · Instrumentation Laboratory CO · 2007K040882 · Vidas D-Dimer Exclusion Assay, Model 30 442 · bioMerieux, Inc. · 2004K020810 · Vidas D-Dimer New (DD2) Assay Model#30 442 · bioMerieux, Inc. · 2002K973819 · Vidas D-Dimer (DD) Assay · Biomerieux Vitek, Inc. · 1998K862156 · Asserachrom D-DI Kit · American Bioproducts Co. · 1986−50
  1. Root · 5 generations backK862156 Asserachrom D-DI KitAmerican Bioproducts Co. · 1986
  2. 4 generations backK973819 Vidas D-Dimer (DD) AssayBiomerieux Vitek, Inc. · 1998
  3. 3 generations backK020810 Vidas D-Dimer New (DD2) Assay Model#30 442bioMerieux, Inc. · 2002
  4. 2 generations backK040882 Vidas D-Dimer Exclusion Assay, Model 30 442bioMerieux, Inc. · 2004
  5. 1 generation backK070927 Hemosil D-Dimer HSInstrumentation Laboratory CO · 2007
  6. This deviceK083518 Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer ControlsInstrumentation Laboratory CO · 2009
  7. Descendant · cites it directly · 0 of its ownK221359 ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2…Instrumentation Laboratory CO · 2023
  8. Descendant · cites it directly · 0 of its ownK170314 ACL AcuStarInstrumentation Laboratory CO · 2017

Most influential descendants

Showing 2 of 2 · See all
  • K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMInstrumentation Laboratory CO · 2023 · cites it directly0descendants
  • K170314ACL AcuStarInstrumentation Laboratory CO · 2017 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K862156Asserachrom D-DI KitAmerican Bioproducts Co.1986—
−4K973819Vidas D-Dimer (DD) AssayBiomerieux Vitek, Inc.1998—
−3K020810Vidas D-Dimer New (DD2) Assay Model#30 442bioMerieux, Inc.2002—
−2K040882Vidas D-Dimer Exclusion Assay, Model 30 442bioMerieux, Inc.2004—
−1K070927Hemosil D-Dimer HSInstrumentation Laboratory CO2007—
0 (this device)K083518Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer ControlsInstrumentation Laboratory CO2009—
+1K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2…Instrumentation Laboratory CO2023—
+1K170314ACL AcuStarInstrumentation Laboratory CO2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199510
199710
200010
200410
200710
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
202310
FIG. 1 — Lineage of K083518, 1986–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243858 TEG 6s Hemostasis System Citrated: K, KH, RT…score 12.0 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K891385Vitek Immunodiagnostic Assay System (Vidas)
Summary page 1
…Regulatory Class: Class It Product Codes: JPA (Instrument), DAP (Assay) and GGN (Controls) Panel: Hematology Predicate Devices: K891385 VIDAS Instrument K040882 VIDAS D-Dimer Exclusion Assay K073377 ACL…
Vitek Systems, Inc.1989—
*K040882Vidas D-Dimer Exclusion Assay, Model 30 442
Summary page 1
…odes: JPA (Instrument), DAP (Assay) and GGN (Controls) Panel: Hematology Predicate Devices: K891385 VIDAS Instrument K040882 VIDAS D-Dimer Exclusion Assay K073377 ACL TOP K070927 HemoslL D-Di…
bioMerieux, Inc.2004—
*K073377Acl Top (with System Software V3.0.0)
Summary page 1
…) Panel: Hematology Predicate Devices: K891385 VIDAS Instrument K040882 VIDAS D-Dimer Exclusion Assay K073377 ACL TOP K070927 HemoslL D-Dimer HS K972696 HemoslL D-Dimer Controls…
Instrumentation Laboratory CO2008—
*K070927Hemosil D-Dimer HS
Summary page 1
…Predicate Devices: K891385 VIDAS Instrument K040882 VIDAS D-Dimer Exclusion Assay K073377 ACL TOP K070927 HemoslL D-Dimer HS K972696 HemoslL D-Dimer Controls Device Indications for Use: * ACL…
Instrumentation Laboratory CO2007—
*K972696IL Test D-Dimer
Summary page 1
…VIDAS Instrument K040882 VIDAS D-Dimer Exclusion Assay K073377 ACL TOP K070927 HemoslL D-Dimer HS K972696 HemoslL D-Dimer Controls Device Indications for Use: * ACL AcuStar: Automated immunoassay analyzer designed…
Instrumentation Laboratory CO1997—

Also cleared against K891385: 1 other device →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMInstrumentation Laboratory CO20230
K170314ACL AcuStarInstrumentation Laboratory CO20170

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 23 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
  • 3 of the 12 ancestors have a recall of any class.
  • Of its descendants, K221359 (Instrumentation Laboratory CO, 2023) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K891385.

How does its category compare?

All JPA devices

JPA System, Multipurpose For In Vitro Coagulation Studies: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · JPA

3in 2025

2007: 12008: 22009: 62010: 12011: 12013: 12015: 22016: 62017: 42018: 12019: 32021: 12022: 12023: 32024: 12025: 32026 (partial year): 1
2007high 6 (2009) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JPA

30in 2025

2009: 91 days median2016: 114 days median2017: 117 days median2019: 175 days median2023: 506 days median2025: 30 days median
2007high 506 (2023) · low 30 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JPA

1in 2020

2007: 12010: 62011: 42012: 12016: 32020: 12026 (partial year): 1
2007high 6 (2010) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JPA

11in 2025

2007: 1,7442008: 9182009: 1,3632010: 7272011: 1612012: 522013: 432014: 482015: 452016: 62017: 152018: 392019: 272020: 182021: 72022: 92023: 112024: 82025: 11
2007high 1,744 (2007) · low 6 (2016)2025

MAUDE reports naming product code JPA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—11,744
20082—0918
200969101,363
20101—6727
20111—4161
20120—152
20131—043
20140—048
20152—045
2016611436
20174117015
20181—039
20193175027
20200—118
20211—07
20221—09
20233506011
20241—08
2025330011
20261—1—

What is it indicated for?

ACL AcuStar: 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.

HemosIL AcuStar D-Dimer: Fully automated chemiluminescent immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL AcuStar as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) and pulmonary embolism (PE)].

HemosIL AcuStar D-Dimer Controls: For the quality control of D-Dimer assay performed on the ACL AcuStar.

Indications for use as stated in the FDA summary.

Also cleared against K891385

1 other device cites the same predicate.

  • K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic…Biomerieux · 20154 recalls

More from Instrumentation Laboratory CO

321 FDA decisions under this applicant name. See the company

  • K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMInstrumentation Laboratory CO · 2023
  • K223187HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 2023
  • K223090GEM Premier ChemSTATInstrumentation Laboratory CO · 2023
  • K223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO · 2022
  • K213464HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 20222 recalls

Recent decisions in JPA

The JPA category page

  • K253658STA Satellite Max®Diagnostica Stago, Inc. · 2026
  • K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)Sysmex America, Inc. · 2025
  • K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics · 2025
  • K243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics Corporation · 2025
  • K232018Citrated: K, KH, RTH, FFHHaemonetics Corporation · 2024

https://510kreport.com/device/K083518 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083518: Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083518

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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