510(k) · Cleared
Recalled · Class I · 2026HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · LCO Platelet Factor 4 Radioimmunoassay
Cleared on Sep 8, 2017 as substantially equivalent to K071255 (Hyphen Biomed, 2007) after a 170-day review. Its family tree reaches back 3 generations to 1999. 1 of the 6 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Sep 8, 2017
- Review
- 170 days
- Class
- Class II
- Product code
- LCO
- Recalls
- 2 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 3 generations to K983379 (1999). 4 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK983379 Gti-PF4 ElisaGenetic Testing Institute · 1999
- 2 generations backK053559 PF4 Enhanced Solid Phase ElisaGenetic Testing Institute · 2006 · Recalled
- 1 generation backK071255 Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040AHyphen Biomed · 2007 · Recalled
- This deviceK170854 HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory CO · 2017
- Descendant · cites it directly · 0 of its ownK243374 HemosIL CL HIT-IgG (PF4-H)Instrumentation Laboratory (IL) Co. · 2025
Most influential descendants
Showing 1 of 1 · See all- K243374HemosIL CL HIT-IgG (PF4-H)Instrumentation Laboratory (IL) Co. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K983379 | Gti-PF4 Elisa | Genetic Testing Institute | 1999 | — |
| −2 | K053559 | PF4 Enhanced Solid Phase Elisa | Genetic Testing Institute | 2006 | 2 |
| −1 | K071255 | Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040A | Hyphen Biomed | 2007 | 8 |
| 0 (this device) | K170854 | HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT Controls | Instrumentation Laboratory CO | 2017 | — |
| +1 | K243374 | HemosIL CL HIT-IgG (PF4-H) | Instrumentation Laboratory (IL) Co. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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.
1 device in this family has a Class I recall. 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 LCO device
- #1 K243374 HemosIL CL HIT-IgG (PF4-H)score 9.7 · 4 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 |
|---|---|---|---|
| * | K071255 | Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040ASummary page 4…Product Code GGN Classification Panel Hematology (81) Predicate Device K071255 (Zymutest HIA IgG from HYPHEN Biomed) 510(k) Summary… | 2007 |
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 |
|---|---|---|---|
| K243374 | HemosIL CL HIT-IgG (PF4-H) | 2025 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 3, 2026 | Class I | Z-0002-2027 | Under Investigation by firm | Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. |
| Sep 3, 2026 | Class I | Z-0001-2027 | Under Investigation by firm | Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K243374 (Instrumentation Laboratory (IL) Co., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LCO devicesLCO Platelet Factor 4 Radioimmunoassay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · LCO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LCO
Too few LCO 510(k)s in any year since 2007 to give a median.
Recalls per year · LCO
3so far in 2026, the most since 2007
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LCO
11in 2025
MAUDE reports naming product code LCO, 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 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 2 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 1 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 2 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 11 |
| 2026 | 0 | — | 3 (2) | — |
What is it indicated for?
HemosIL AcuStar HIT-IgG(PF4-H) is a qualitative, fully automated, chemiluminescent immunoassay (CIA) for the detection of IgG antibodies that react with Platelet Factor 4 (PF4) when complexed to heparin. The assay is for use in human 3.2% or 3.8% citrated plasma and serum on the ACL AcuStar instrument in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.00 U/mL). The…
Read the full statement (143 words)
HemosIL AcuStar HIT-IgG(PF4-H) is a qualitative, fully automated, chemiluminescent immunoassay (CIA) for the detection of IgG antibodies that react with Platelet Factor 4 (PF4) when complexed to heparin. The assay is for use in human 3.2% or 3.8% citrated plasma and serum on the ACL AcuStar instrument in a laboratory setting.
The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.00 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings.
Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT.
HemoslL AcuStar HIT Controls are for the quality control of the HemosIL AcuStar HIT-IgG(PF4-H) assay as performed on the ACL AcuStar.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170854: HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170854
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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