PMA · Approved
Recalled · 2005Dako Herceptest
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agilent Technologies Singapore (International) Pte, Ltd. · MVC System, Test, Her-2/Neu, Ihc
Approved on Sep 25, 1998 through premarket approval, which rests on the device’s own clinical evidence after a 130-day review. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 25, 1998
- Review
- 130 days
- Class
- Class III
- Product code
- MVC
- Recalls
- 1
2 later devices descend from it, 1 citing it directly.
- This deviceP980018 Dako HerceptestAgilent Technologies Singapore (International) Pte, Ltd. · 1998
- Descendant · cites it directly · 1 of its ownK023335 QCS HER2 Immunocontrols (Product NO. C010)Qc Sciences, LLC · 2003
- Descendant · 2 generations on · 0 of its ownK220163 Her-2, ER, PR IHControlsBoston Cell Standards, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P980018 | Dako Herceptest | Agilent Technologies Singapore (International) Pte, Ltd. | 1998 | — |
| +1 | K023335 | QCS HER2 Immunocontrols (Product NO. C010) | Qc Sciences, LLC | 2003 | — |
| +2 | K220163 | Her-2, ER, PR IHControls | Boston Cell Standards, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MVC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023335 | QCS HER2 Immunocontrols (Product NO. C010) | 2003 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 29, 2005 | Not classified | Z-0113-06 | Other | Formulation error in the Visualization Reagent (vial 3) component contained in Hercep Test kits. The error was in the concentration of Polyethylene Glycol contained in the formulation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K023335 (Qc Sciences, LLC, 2003) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MVC devicesMVC System, Test, Her-2/Neu, Ihc: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MVC
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MVC
Too few MVC 510(k)s in any year since 2007 to give a median.
Recalls per year · MVC
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MVC
2in 2021
MAUDE reports naming product code MVC, 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 | 4 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 4 |
| 2010 | 6 | — | 0 | 0 |
| 2011 | 6 | — | 0 | 0 |
| 2012 | 5 | — | 0 | 2 |
| 2013 | 13 | — | 0 | 2 |
| 2014 | 7 | — | 0 | 1 |
| 2015 | 7 | — | 0 | 4 |
| 2016 | 3 | — | 0 | 3 |
| 2017 | 5 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 2 |
| 2019 | 7 | — | 0 | 0 |
| 2020 | 6 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 3 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 3 | — | 0 | 0 |
| 2025 | 4 | — | 0 | 0 |
| 2026 | 5 | — | 0 | — |
https://510kreport.com/device/P980018 · printed Nov 6, 2026
Cite this page
510(k) Report. “P980018: Dako Herceptest.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P980018
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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