510(k) · Decided
DecidedPathwork Diagnostics Tissue of Origin Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pathwork Diagnostics, Inc. · OIW Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types
Cleared on Jul 30, 2008 as substantially equivalent to K043341 (Bio-Rad Laboratories, Inc., 2005) after a 121-day review. Its family tree reaches back 2 generations to 1995. 3 later devices descend from it.
- Decided
- Jul 30, 2008
- Review
- 121 days
- Class
- Class II
- Product code
- OIW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K941596 (1995). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK941596 Remedi HS Drug Profiling SystemBio-Rad · 1995
- 1 generation backK043341 Bioplex 2200 Ana Screen with Medical Decision Support Software for…Bio-Rad Laboratories, Inc. · 2005 · Recalled
- This deviceK080896 Pathwork Diagnostics Tissue of Origin TestPathwork Diagnostics, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK092967 Pathwork Tissue of Origin Test Kit-Ffpe (Origin Test Kit-FfpePathwork Diagnostics · 2010
- Descendant · 2 generations on · 1 of its ownK120489 Tissue of Origin Test Kit FfpePathwork Diagnostics, Inc. · 2012
- Descendant · 3 generations on · 0 of its ownK173839 Tissue of Origin Test Kit-FFPECancer Genetics, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See all- K092967Pathwork Tissue of Origin Test Kit-Ffpe (Origin Test Kit-FfpePathwork Diagnostics · 2010 · cites it directly2descendants
- K120489Tissue of Origin Test Kit FfpePathwork Diagnostics, Inc. · 2012 · 2 generations on1descendant
- K173839Tissue of Origin Test Kit-FFPECancer Genetics, Inc. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941596 | Remedi HS Drug Profiling System | Bio-Rad | 1995 | — |
| −1 | K043341 | Bioplex 2200 Ana Screen with Medical Decision Support Software for Use with… | Bio-Rad Laboratories, Inc. | 2005 | 2 |
| 0 (this device) | K080896 | Pathwork Diagnostics Tissue of Origin Test | Pathwork Diagnostics, Inc. | 2008 | — |
| +1 | K092967 | Pathwork Tissue of Origin Test Kit-Ffpe (Origin Test Kit-Ffpe | Pathwork Diagnostics | 2010 | — |
| +2 | K120489 | Tissue of Origin Test Kit Ffpe | Pathwork Diagnostics, Inc. | 2012 | — |
| +3 | K173839 | Tissue of Origin Test Kit-FFPE | Cancer Genetics, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 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 OIW? 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
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 |
|---|---|---|---|
| * | K043341 | Bioplex 2200 Ana Screen with Medical Decision Support Software for Use with Bioplex 2200…Summary page 1…e (MDSS) on the BioPlex 2200 Multi-Analyte Detection System, (Bio-Rad Laboratories, Hercules, CA), cleared under premarket notification K043341 on October 27, 2005. Section 6-510(k) Summary- Revised 2 Page… | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092967 | Pathwork Tissue of Origin Test Kit-Ffpe (Origin Test Kit-Ffpe | 2010 | 2 |
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 13 years and passes through 3 companies; a new generation was cleared every 10.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K092967 (Pathwork Diagnostics, 2010) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K043341.
How does its category compare?
All OIW devicesOIW Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · OIW
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · OIW
Too few OIW 510(k)s in any year since 2007 to give a median.
Recalls per year · OIW
No recall names OIW since 2007.
Adverse event reports per year · OIW
No MAUDE report names OIW since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Pathwork® Tissue of Origin Test is intended to measure the degree of similarity between the RNA expression pattern in a patient's fresh-frozen tumor and the RNA expression patterns in a database of tumor samples (poorly differentiated, undifferentiated and metastatic cases) that were diagnosed according to then current clinical and pathological practice. The database contains examples of RNA expression patterns for fifteen common malignant tumor…
Read the full statement (221 words)
The Pathwork® Tissue of Origin Test is intended to measure the degree of similarity between the RNA expression pattern in a patient's fresh-frozen tumor and the RNA expression patterns in a database of tumor samples (poorly differentiated, undifferentiated and metastatic cases) that were diagnosed according to then current clinical and pathological practice. The database contains examples of RNA expression patterns for fifteen common malignant tumor types: bladder, breast, colorectal, gastric, hepatocellular, kidney, non-small cell lung, ovarian, pancreatic, prostate and thyroid cancinominas, melanoma, testicular germ cell tumor, non-Hodgkins lymphoma (not otherwise specified), and soft tissue sarcoma (not otherwise specified). The Pathwork® Tissue of Origin Test result is intended for use in the context of the patient's clinical history and other diagnostic tests evaluated by a qualified clinician.
Limitations:
The Pathwork® Tissue of Origin Test is not intended to establish the origin of tumors (e.g. carcinoma of unknown primary) that cannot be diagnosed according to current clinical and pathological practice. It is not intended to subclassify or modify the classification of tumors that can be diagnosed by current clinical and pathological practice, nor to predict disease course or survival or treatment efficacy, not to distinguish primary from metastatic tumor. Tumor types not in the Pathwork® Tissue of Origin Test database may have RNA expression patterns that are similar to patterns in the database.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080896 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080896: Pathwork Diagnostics Tissue of Origin Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080896
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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