510(k) · Cleared
Recalled · Class II · 2025Asserachrom Hpia Test Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostica Stago, Inc. · LCO Platelet Factor 4 Radioimmunoassay
Cleared on Feb 12, 2001 after a 68-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 5 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled once.
- Decided
- Feb 12, 2001
- Review
- 68 days
- Class
- Class II
- Product code
- LCO
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- This deviceK003767 Asserachrom Hpia Test KitDiagnostica Stago, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK071255 Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040AHyphen Biomed · 2007 · Recalled
- Descendant · 2 generations on · 1 of its ownK170854 HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory CO · 2017 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK243374 HemosIL CL HIT-IgG (PF4-H)Instrumentation Laboratory (IL) Co. · 2025
- Descendant · cites it directly · 0 of its ownK153137 HemosIL HIT-Ab (PF4-H), HemosIL HIT-Ab (PF4-H) ControlsInstrumentation Laboratory CO · 2016
Class I recalls in this family
- K170854 HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar…2 generations on · 2017
Most influential descendants
Showing 4 of 4 · See all- K071255Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040AHyphen Biomed · 2007 · cites it directly2descendants
- K170854HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory CO · 2017 · 2 generations on1descendant
- K243374HemosIL CL HIT-IgG (PF4-H)Instrumentation Laboratory (IL) Co. · 2025 · 3 generations on0descendants
- K153137HemosIL HIT-Ab (PF4-H), HemosIL HIT-Ab (PF4-H) ControlsInstrumentation Laboratory CO · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003767 | Asserachrom Hpia Test Kit | Diagnostica Stago, Inc. | 2001 | — |
| +1 | K071255 | Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040A | Hyphen Biomed | 2007 | 8 |
| +2 | K170854 | HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT Controls | Instrumentation Laboratory CO | 2017 | Class I |
| +3 | K243374 | HemosIL CL HIT-IgG (PF4-H) | Instrumentation Laboratory (IL) Co. | 2025 | — |
| +1 | K153137 | HemosIL HIT-Ab (PF4-H), HemosIL HIT-Ab (PF4-H) Controls | Instrumentation Laboratory CO | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 1 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 15, 2025 | Class II | Z-1084-2026 | Under Investigation by firm | Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results. |
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 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K071255 (Hyphen Biomed, 2007) has gone furthest, with 2 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.
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) | — |
https://510kreport.com/device/K003767 · printed Nov 5, 2026
Cite this page
510(k) Report. “K003767: Asserachrom Hpia Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003767
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026