510(k) · Cleared
ClearedGti-PF4 Elisa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genetic Testing Institute · LCO Platelet Factor 4 Radioimmunoassay
Cleared on Mar 9, 1999 after a 165-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 10 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.
- Decided
- Mar 9, 1999
- Review
- 165 days
- Class
- Class II
- Product code
- LCO
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- This deviceK983379 Gti-PF4 ElisaGenetic Testing Institute · 1999
- Descendant · cites it directly · 6 of its ownK053559 PF4 Enhanced Solid Phase ElisaGenetic Testing Institute · 2006 · Recalled
- Descendant · 2 generations on · 2 of its ownK071255 Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040AHyphen Biomed · 2007 · Recalled
- Descendant · 3 generations on · 1 of its ownK170854 HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory CO · 2017 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK071781 PF4 IGGGenetic Testing Institute · 2007
- Descendant · 4 generations on · 0 of its ownK243374 HemosIL CL HIT-IgG (PF4-H)Instrumentation Laboratory (IL) Co. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K170854 HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar…3 generations on · 2017
Most influential descendants
Showing 5 of 9 · See all- K053559PF4 Enhanced Solid Phase ElisaGenetic Testing Institute · 2006 · cites it directly6descendants
- K071255Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040AHyphen Biomed · 2007 · 2 generations on2descendants
- K170854HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory CO · 2017 · 3 generations on1descendant
- K071781PF4 IGGGenetic Testing Institute · 2007 · 2 generations on1descendant
- K243374HemosIL CL HIT-IgG (PF4-H)Instrumentation Laboratory (IL) Co. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983379 | Gti-PF4 Elisa | Genetic Testing Institute | 1999 | — |
| +1 | 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 |
| +3 | K170854 | HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT Controls | Instrumentation Laboratory CO | 2017 | Class I |
| +2 | K071781 | PF4 IGG | Genetic Testing Institute | 2007 | — |
| +4 | K243374 | HemosIL CL HIT-IgG (PF4-H) | Instrumentation Laboratory (IL) Co. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2017 | 1 | 1 |
| 2020 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (9)
3 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)
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 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K053559 (Genetic Testing Institute, 2006) has gone furthest, with 6 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) | — |
What is it indicated for?
INDICATIONS FOR USE OF GTI-PF4 ELISA
FOR THE DETECTION OF ANTIBODIES DIRECTED
AGAINST PLATELET FACTOR 4 (PF4):POLYVINYL SULFONATE (PVS) COMPLEX
GTI-PF4 ELISA is designed as a solid phase enzyme-linked immunosorbent assay (ELISA). The product is intended to be used as an in vitro diagnostic kit by hematology, coagulation or other pathology laboratories to assist in screening patient samples for the presence of heparin-associated antibodies commonly found in patients with heparin-induced thrombocytopenia or thrombosis.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983379 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983379: Gti-PF4 Elisa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983379
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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