510(k) · Cleared
ClearedPathiam System for HER2/Neu Immunohistochemistry Reagents & Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioimagene, Inc. · NOT Microscope, Automated, Image Analysis, Operator Intervention
Cleared on Feb 4, 2009 as substantially equivalent to K062756 (Bioimagene, Inc., 2007) after a 309-day review. Its family tree reaches back 2 generations to 2003.
- Decided
- Feb 4, 2009
- Review
- 309 days
- Class
- Class II
- Product code
- NOT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K032113 (2003). No later device cites it as a predicate yet.
- Root · 2 generations backK032113 Acis (Automated Cellular Imaging System)Chroma Vision Medical Systems, Inc. · 2003
- 1 generation backK062756 Pathiam Imaging Software for HER2/NeuBioimagene, Inc. · 2007
- This deviceK080910 Pathiam System for HER2/Neu Immunohistochemistry Reagents & KitsBioimagene, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K032113 | Acis (Automated Cellular Imaging System) | Chroma Vision Medical Systems, Inc. | 2003 | — |
| −1 | K062756 | Pathiam Imaging Software for HER2/Neu | Bioimagene, Inc. | 2007 | — |
| 0 (this device) | K080910 | Pathiam System for HER2/Neu Immunohistochemistry Reagents & Kits | Bioimagene, Inc. | 2009 | — |
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 NOT? 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 NOT device
- #1 K260755 OptraSCAN Systemscore 12.2 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K062756 | Pathiam Imaging Software for HER2/NeuSummary page 2…® (Trastuzumab) treatment is being considered. The pathologist should verify agreement with the PATHIAM score. Predicate Device: PATHIAM Imaging Software for HER2/neu, K062756 Regulation: 21 CFR §864.1860 Product Code: NOT Panel: Pathology Performance: a. Reproducibility Study between Pathologists and… | 2007 |
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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All NOT devicesNOT Microscope, Automated, Image Analysis, Operator Intervention: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NOT
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · NOT
Too few NOT 510(k)s in any year since 2007 to give a median.
Recalls per year · NOT
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NOT
1in 2023
MAUDE reports naming product code NOT, 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 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 1 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
PATHIAM-Assisted Scoring: Intended for clinical laboratory use as an accessory to the DAKO HercepTest to aid in the detection and semi-quantitative measurement of Her2/neu in form ain fixed, paraffin-embedded normal and neoplastic tissue. When used with the DAKO HercepTest, Pathiam Assisted Scoring is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN (Trastuzumab) treatment is being considered. The pathologist…
Read the full statement (111 words)
PATHIAM-Assisted Scoring: Intended for clinical laboratory use as an accessory to the DAKO HercepTest to aid in the detection and semi-quantitative measurement of Her2/neu in form ain fixed, paraffin-embedded normal and neoplastic tissue. When used with the DAKO HercepTest, Pathiam Assisted Scoring is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN (Trastuzumab) treatment is being considered. The pathologist should verify agreement with the PATHIAM System score.
HER2/neu results are indicated for use as an aid in the management, prognosis and predication of therapy outcomes of breast cancer. Note: The actual correlation of the DAKO HercepTest to Herceptin® clinical outcome has not been established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080910 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080910: Pathiam System for HER2/Neu Immunohistochemistry Reagents & Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080910
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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