510(k) · Cleared
ClearedPF4 IGG
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 Dec 19, 2007 as substantially equivalent to K053559 (Genetic Testing Institute, 2006) after a 170-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it.
- Decided
- Dec 19, 2007
- Review
- 170 days
- Class
- Class II
- Product code
- LCO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K983379 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK983379 Gti-PF4 ElisaGenetic Testing Institute · 1999
- 1 generation backK053559 PF4 Enhanced Solid Phase ElisaGenetic Testing Institute · 2006 · Recalled
- This deviceK071781 PF4 IGGGenetic Testing Institute · 2007
- Descendant · cites it directly · 0 of its ownK201311 PF4 IgG assayImmucor Gti Diagnostics, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K201311PF4 IgG 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 |
|---|---|---|---|---|---|
| −2 | K983379 | Gti-PF4 Elisa | Genetic Testing Institute | 1999 | — |
| −1 | K053559 | PF4 Enhanced Solid Phase Elisa | Genetic Testing Institute | 2006 | 2 |
| 0 (this device) | K071781 | PF4 IGG | Genetic Testing Institute | 2007 | — |
| +1 | K201311 | PF4 IgG assay | Immucor Gti Diagnostics, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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.
Planning a device in LCO? 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 |
|---|---|---|---|
| * | K053559 | PF4 Enhanced Solid Phase ElisaSummary page 1…or 4 Radioimmumassy Product Code: LCO III. Name of predicate device for claiming equivalence GTL-PF4 ENHANCED® (K053559) IV. Description of Device: The PF4 JgGTm assay is an Enzyme Linked Immunrosorbent Assay (ELISA). The… | 2006 |
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 |
|---|---|---|---|
| K201311 | PF4 IgG assay | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 6.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K201311 (Immucor Gti Diagnostics, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K053559.
How does its category compare?
All LCO devicesLCO Platelet Factor 4 Radioimmunoassay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
PF4 IgGTM is a qualitative screening assay for the detection of heparin associated IgG antibodies in human serum. The presence of heparin associated antibodies are commonly found in patients with Heparin Induced Thrombocytopenia (HIT).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071781: PF4 IGG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071781
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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