510(k) · Cleared
ClearedHealthtest Heparin/Platelet Factor 4 Antibody Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Akers Laboratories, Inc. · LCO Platelet Factor 4 Radioimmunoassay
Cleared on May 28, 2004 as substantially equivalent to K983379 (Genetic Testing Institute, 1999) after a 112-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- May 28, 2004
- Review
- 112 days
- Class
- Class II
- Product code
- LCO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983379 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK983379 Gti-PF4 ElisaGenetic Testing Institute · 1999
- This deviceK040293 Healthtest Heparin/Platelet Factor 4 Antibody AssayAkers Laboratories, Inc. · 2004
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) | K040293 | Healthtest Heparin/Platelet Factor 4 Antibody Assay | Akers Laboratories, Inc. | 2004 | — |
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 |
|---|---|---|---|
| * | K983379 | Gti-PF4 ElisaSummary page 1…T®Heparin/Platelet Factor 4 Antibody Assay is substantially equivelant to the GTI PF4 Elisa Assay, Genetic Testing Institute, Waukesha, WI; K983379 807.92 (a)(4): Device Description The HealthTEST® Heparin/Platelet Factor 4 Antibody Assay consists of… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K983379.
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?
The HEALTHTEST® Heparin/Platelet Factor 4 Antibody Assay is a qualitative in vitro diagnostic device designed for the detection of antibodies to the Platelet Factor 4 complexed to polyanionic compounds such as polystyrene. These antibodies are found in some patients undergoing heparin therapy. The risk of heparin induced thrombocytopenia (HIT) is greatly increased in patients with recent exposure to heparin. The presence of heparin/PF-4 antibody is…
Read the full statement (119 words)
The HEALTHTEST® Heparin/Platelet Factor 4 Antibody Assay is a qualitative in vitro diagnostic device designed for the detection of antibodies to the Platelet Factor 4 complexed to polyanionic compounds such as polystyrene. These antibodies are found in some patients undergoing heparin therapy.
The risk of heparin induced thrombocytopenia (HIT) is greatly increased in patients with recent exposure to heparin. The presence of heparin/PF-4 antibody is associated with patients at risk for HIT, and is rapidly becoming a standard of care in hematology and cardiology. The need for a rapid test to detect these antibodies from serum or plasma in less than 5 minutes is highly desired. This rapid manual assay should be easily performed when STAT results are required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040293 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040293: Healthtest Heparin/Platelet Factor 4 Antibody Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040293
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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