510(k) · Cleared
Recalled · Class II · 2014PF4 Enhanced Solid Phase 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 Jan 20, 2006 as substantially equivalent to K983379 (Genetic Testing Institute, 1999) after a 30-day review. Its family tree reaches back 1 generation to 1999. 1 of the 8 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 20, 2006
- Review
- 30 days
- Class
- Class II
- Product code
- LCO
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983379 (1999). 6 later devices descend from it, 3 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK983379 Gti-PF4 ElisaGenetic Testing Institute · 1999
- This deviceK053559 PF4 Enhanced Solid Phase ElisaGenetic Testing Institute · 2006
- 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 · cites it directly · 1 of its ownK071781 PF4 IGGGenetic Testing Institute · 2007
- 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 ownK201570 PF4 Enhanced assayImmucor Gti Diagnostics, Inc. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K170854 HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar…2 generations on · 2017
Most influential descendants
Showing 5 of 6 · 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
- K071781PF4 IGGGenetic Testing Institute · 2007 · cites it directly1descendant
- K243374HemosIL CL HIT-IgG (PF4-H)Instrumentation Laboratory (IL) Co. · 2025 · 3 generations on0descendants
- K201570PF4 Enhanced assayImmucor Gti Diagnostics, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983379 | Gti-PF4 Elisa | Genetic Testing Institute | 1999 | — |
| 0 (this device) | K053559 | PF4 Enhanced Solid Phase Elisa | Genetic Testing Institute | 2006 | — |
| +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 |
| +1 | K071781 | PF4 IGG | Genetic Testing Institute | 2007 | — |
| +3 | K243374 | HemosIL CL HIT-IgG (PF4-H) | Instrumentation Laboratory (IL) Co. | 2025 | — |
| +1 | K201570 | PF4 Enhanced assay | Immucor Gti Diagnostics, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2017 | 1 | 1 |
| 2020 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K983379 | Gti-PF4 ElisaSummary page 1…ct Code: 0545 Ill. Name of predicate device for claiming equivalence GTI-PF4 ELISA (K983379) IV. Description of Device: PF4 ENHANCED® S… | 1999 |
What descends from it? (6)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 15, 2014 | Class II | Z-1001-2015 | Employee error | Some Lots of PF4 Concentrated Wash (10X) are a slightly more dilute concentration. This may lead to slightly increased Optical Density (OD) values. Samples with a higher background reactivity may demonstrate false positive result… |
| Feb 4, 2013 | Class II | Z-1022-2013 | Process control | Lifecodes PF4 Enhanced assay, lot number 3000389, is being recalled because of observed inconsistent replicate values when testing the kit Positive Control and patient samples. The variation in reactivity can lead to invalid assays. If an… |
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?
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?
GTI PF4 ENHANCED® is designed as a solid phase enzyme-linked immunosorbent assay (ELISA). The product is intended to be used as an in vitro diagnostics 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 as stated in the FDA summary.
https://510kreport.com/device/K053559 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053559: PF4 Enhanced Solid Phase Elisa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053559
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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