510(k) · Cleared
ClearedHemosIL CL HIT-IgG (PF4-H)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory (IL) Co. · LCO Platelet Factor 4 Radioimmunoassay
Cleared on Jan 28, 2025 as substantially equivalent to K170854 (Instrumentation Laboratory CO, 2017) after a 90-day review. Its family tree reaches back 4 generations to 1999. 1 of the 6 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 28, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- LCO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K983379 (1999). 5 ancestors in all. No later device cites it as a predicate yet. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK983379 Gti-PF4 ElisaGenetic Testing Institute · 1999
- 3 generations backK053559 PF4 Enhanced Solid Phase ElisaGenetic Testing Institute · 2006 · Recalled
- 2 generations backK071255 Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040AHyphen Biomed · 2007 · Recalled
- 1 generation backK170854 HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory CO · 2017 · Recalled (Class I)
- This deviceK243374 HemosIL CL HIT-IgG (PF4-H)Instrumentation Laboratory (IL) Co. · 2025
Class I recalls in this family
- K170854 HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar…direct predicate · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K983379 | Gti-PF4 Elisa | Genetic Testing Institute | 1999 | — |
| −3 | K053559 | PF4 Enhanced Solid Phase Elisa | Genetic Testing Institute | 2006 | 2 |
| −2 | K071255 | Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040A | Hyphen Biomed | 2007 | 8 |
| −1 | K170854 | HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT Controls | Instrumentation Laboratory CO | 2017 | Class I |
| 0 (this device) | 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 |
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 K201570 PF4 Enhanced assayscore 0.3 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K170854 | HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT ControlsSummary page 5…me HemosIL CL HIT-IgG(PF4-H) Predicate Devices HemosIL AcuStar HIT-IgG(PF4-H) K170854 and 510(k) Number Regulatory Information Chemiluminescent Assay… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K170854HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory CO · 2017 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 7.4 years on median.
- 4 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All LCO devicesLCO Platelet Factor 4 Radioimmunoassay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 CL 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% citrated plasma on the ACL TOP 970 CL 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…
Read the full statement (119 words)
HemosIL CL 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% citrated plasma on the ACL TOP 970 CL 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243374 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243374: HemosIL CL HIT-IgG (PF4-H).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243374
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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