510(k) · Cleared
ClearedTissue of Origin Test Kit-FFPE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cancer Genetics, Inc. · OIW Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types
Cleared on Mar 15, 2018 as substantially equivalent to K120489 (Pathwork Diagnostics, Inc., 2012) after an 87-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Mar 15, 2018
- Review
- 87 days
- Class
- Class II
- Product code
- OIW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K941596 (1995). No later device cites it as a predicate yet.
- Root · 5 generations backK941596 Remedi HS Drug Profiling SystemBio-Rad · 1995
- 4 generations backK043341 Bioplex 2200 Ana Screen with Medical Decision Support Software for…Bio-Rad Laboratories, Inc. · 2005 · Recalled
- 3 generations backK080896 Pathwork Diagnostics Tissue of Origin TestPathwork Diagnostics, Inc. · 2008
- 2 generations backK092967 Pathwork Tissue of Origin Test Kit-Ffpe (Origin Test Kit-FfpePathwork Diagnostics · 2010
- 1 generation backK120489 Tissue of Origin Test Kit FfpePathwork Diagnostics, Inc. · 2012
- This deviceK173839 Tissue of Origin Test Kit-FFPECancer Genetics, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K941596 | Remedi HS Drug Profiling System | Bio-Rad | 1995 | — |
| −4 | K043341 | Bioplex 2200 Ana Screen with Medical Decision Support Software for Use with… | Bio-Rad Laboratories, Inc. | 2005 | 2 |
| −3 | K080896 | Pathwork Diagnostics Tissue of Origin Test | Pathwork Diagnostics, Inc. | 2008 | — |
| −2 | K092967 | Pathwork Tissue of Origin Test Kit-Ffpe (Origin Test Kit-Ffpe | Pathwork Diagnostics | 2010 | — |
| −1 | K120489 | Tissue of Origin Test Kit Ffpe | Pathwork Diagnostics, Inc. | 2012 | — |
| 0 (this device) | K173839 | Tissue of Origin Test Kit-FFPE | Cancer Genetics, Inc. | 2018 | — |
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 |
|---|---|---|---|
| * | K120489 | Tissue of Origin Test Kit FfpeSummary page 4…rigin Test Kit-FFPE as modified is substantially equivalent to the Pathwork Tissue of Origin Test Kit FFPE cleared under premarket notification K120489 on May 17, 2012 (which is substantially equivalent to the Pathwork Tissue of Origin Test Kit FFPE cleared under… | 2012 |
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 23 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
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. 2018, 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?
Indication for Use: The Cancer Genetics Tissue of Origin Test is an in vitro diagnostic intended to measure the degree of similarity between the RNA expression patterns in a patient's formalin-fixed, paraffin-embedded (FFPE) tumor and the RNA expression patterns in a database of fifteen tumor types (poorly differentiated, undifferentiated and metastatic cases) that were diagnosed according to then current clinical and pathological practice. This test…
Read the full statement (201 words)
Indication for Use: The Cancer Genetics Tissue of Origin Test is an in vitro diagnostic intended to measure the degree of similarity between the RNA expression patterns in a patient's formalin-fixed, paraffin-embedded (FFPE) tumor and the RNA expression patterns in a database of fifteen tumor types (poorly differentiated, undifferentiated and metastatic cases) that were diagnosed according to then current clinical and pathological practice. This test should be evaluated by a qualified physician in the context of the patient's clinical history and other diagnostic test results.
Limitations: The Cancer Genetics Tissue of Origin Test is not intended to establish the origin of tumors (e.g., cancer 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, nor to distinguish primary from metastatic tumor. Tumor types not in the Cancer Genetics Tissue of Origin Test database may have RNA expression patterns that are similar to patterns in the database. Therefore, results cannot be used to distinguish tumor types in the database from tumor types not in the database.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173839 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173839: Tissue of Origin Test Kit-FFPE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173839
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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