Who is the manufacturer of PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST?

Pathwork Diagnostics, Inc. filed the 510(k) submission for PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST (K080896).

What is the FDA product code for PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST?

OIW. It is classified under 21 CFR 862.3100 as a Class 2 device in the Clinical Toxicology panel.

What is the regulatory pathway for PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST?

510(k) clearance (submission type: Traditional).

Does PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST use AI or machine learning?

Yes. PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST (K080896) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST?

BioPlex™ 2200 Medical Decision Support Software (MDSS) (k043341).

Who can help prepare an FDA 510(k) submission like PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST

K080896 · Pathwork Diagnostics, Inc. · OIW · Jul 30, 2008 · Clinical Toxicology

Device Facts

Record ID	K080896
Device Name	PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST
Applicant	Pathwork Diagnostics, Inc.
Product Code	OIW · Clinical Toxicology
Decision Date	Jul 30, 2008
Decision	SESU
Submission Type	Traditional
Regulation	21 CFR 862.3100
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

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 carcinomas, 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, nor 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. Therefore, results cannot be used to distinguish tumor types in the database from tumor types not in the database.

Device Story

Test kit uses Pathchip microarray to measure RNA expression in fresh-frozen tumor biopsies; requires 100mg tissue with ≥60% tumor content. Input: total RNA isolated from homogenized tissue; processed via reverse transcription, cDNA synthesis, cRNA labeling/fragmentation, and hybridization to Pathchip. System software (remote processing via secure FTP) normalizes data and applies machine learning algorithm to generate 15 similarity scores (0-100). Used in clinical laboratories; results interpreted by pathologists/clinicians using Guide to Report Interpretation (GRI) alongside clinical history. Output: PDF report quantifying similarity to 15 tumor types. Assists clinicians in identifying tissue of origin for challenging cases.

Clinical Evidence

Clinical validation study across four laboratories using 545 tumor specimens (poorly differentiated, undifferentiated, metastatic). Primary endpoints: Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) with available diagnosis. Overall PPA 89.4% (95% CI: 86.5-91.8%), overall NPA 99.6% (95% CI: 98.6-100.0%). Reproducibility study (n=192) showed 91.2% agreement with diagnosis. Off-panel study (n=143) indicated high false-positive rates for non-panel tumor types.

Technological Characteristics

Microarray-based gene expression analysis. Components: Pathchip microarray, reagents for RNA extraction/processing. Requires external scanner (e.g., Affymetrix GeneChip GCS3000Dx). Connectivity: Secure internet transfer of data files to cloud-based/remote Pathwork System Software. Analysis: Software-based comparison of RNA expression patterns against a database of 15 tumor types.

Indications for Use

Indicated for patients with poorly differentiated, undifferentiated, or metastatic tumors to measure similarity of RNA expression patterns to 15 common malignant tumor types. Not for establishing origin of tumors that cannot be diagnosed by current practice, subclassification, predicting disease course/survival/treatment efficacy, or distinguishing primary from metastatic tumors.

Regulatory Classification

Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Predicate Devices

BioPlex™ 2200 Medical Decision Support Software (MDSS) (k043341)

Related Devices

K092967 — PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE · Pathwork Diagnostics · Jun 8, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Pathwork Diagnostics. The logo consists of a stylized graphic to the left of the word "Pathwork" in a bold, sans-serif font. Below "Pathwork" is the word "Diagnostics" in a smaller font. The logo is simple and professional, and it is likely used to represent the company's brand. 1196 Borregas Avenue Suite 200 Sunnyvale, CA 94089 JUL 30 2008 ### SECTION 6 510(k) SUMMARY This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is K080896 | 807.92 (a)(1): | Name: | Pathwork® Diagnostics, Inc | |----------------|--------------------|------------------------------------------------------------| | | Address: | 1196 Borregas Avenue Suite 200 Sunnyvale, CA 94089 | | | Phone: Contact: | 408-400-0828 x103 Glenda G. Anderson Founder and CTO | 807.92 (a)(2): Device Name - trade name and common name, and classification | Trade name: | Pathwork® Tissue of Origin Test | |-----------------|------------------------------------------------------------------------------------------------| | Common name: | Microarray and software system kit for gene expression-based diagnostics | | Classification: | 21 CFR § 862.3100, Amphetamine Test System Class II, Product Code NVI (diagnostic software) | Identification of the legally marketed predicate device 807.92 (a)(3): The Tissue of Origin Test is substantially equivalent to the BioPlex 2200 Medical Decision Support software (MDSS) on the BioPlex 2200 Multi-Analyte Detection System, (Bio-Rad Laboratories, Hercules, CA), cleared under premarket notification K043341 on October 27, 2005. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Pathwork Diagnostics. The logo consists of a stylized black and white image of a winding road on the left, followed by the word "Pathwork" in a bold, sans-serif font. Below "Pathwork" is the word "Diagnostics" in a smaller font. ## 807.92 (a)(4): Device Description The Pathwork® Tissue of Origin Test is a microarray and analytics "kit" that quantifies the similarity of tumor specimens to 15 cancer types representing 60 morphologies. Frozen biopsy specimens are processed by the clinical laboratory as described in the User Guide. In brief, mRNA is extracted, amplified, labeled and hybridized to the Pathchip® microarray, which is then scanned using one of the instrument systems validated for use with this test. The resulting data file is transmitted via secure internet transfer protocol to the Pathwork® System Software for data quality control and analysis. Test results are available for clinical interpretation via a secure password protected website. ## Components included in the kit Microarray: Pathchip microarrays, packaged in boxes of 5 or 10. Tissue of Origin Test Report produced by the Pathwork System Software (by licensed agreement): The Pathwork® System Software receives data from the scanned Pathchip™ microarray and performs data quality control and analysis. The System Software then generates a Pathwork® Tissue of Origin Test Report which provides a Similarity Score for each of the 15 tissues on the test panel. The test report is accessible for clinical interpretation via a secure password protected website. Tissue of Origin Test Reagents: Reagents for specimen processing and RNA extraction. ## 807.92 (a)(5): Intended Use Indications for Use: 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 carcinomas, 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 that cannot be diagnosed according to current clinical and pathological practice. (e.g. carcinoma of unknown primary). 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 Pathwork Tissue of Origin Test database may have RNA expression patterns that are similar to RNA expression patterns in tumor types in the database, leading to indeterminate results or misclassifications, {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for Pathwork Diagnostics. The logo consists of a stylized image of a path on the left, followed by the word "Pathwork" in a bold, sans-serif font. Below "Pathwork" is the word "Diagnostics" in a smaller font. # 1 1 96 Borregas Avenue Suite 200 Sunnyvale, CA 94089 # 807.92 (a)(6): Technological Similarities and Differences to Predicate | | Tissue of Origin Test K080896 | Bioplex 2200 Medical Decision Support Software K043341 | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | CHARACTERISTIC | | | | Intended Use | Indications for Use: 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 carcinomas, 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. | The Bioplex 2200 Medical Decision Support Software (MDSS), used in conjunction with the ANA Screen, is an optional laboratory tool that associates patient antibody results with predefined MDSS profiles that have been correlated with the following systemic autoimmune diseases: SLE, Mixed Connective Tissue Disease, Sjogren's Syndrome, Scleroderma, and Polymyositis | | Principle of Operation | The frozen biopsy specimen is processed by the clinical laboratory and is then hybridized to the Pathchip microarray. The Pathchip is scanned and the resulting intensity data file is processed by the Pathwork System Software. The results are presented to the laboratory as a Pathwork Tissue of Origin Test Report (secure internet access; pdf file) that quantifies the similarity of the RNA expression pattern found in a tumor specimen (poorly or un-differentiated primary tumors, as well as metastatic tumors) to expression patterns found in tumor specimens from 15 known tissues of origin. | The autoantibody results from the chemistry assay are compared to the MDSS database that contain results for over 1,400 sera/plasma, representing test results from patients with systemic autoimmune diseases and from healthy individuals. If one or more results are obtained from a serum or plasma sample, the results are associated with the most appropriate MDSS profiles. When the MDSS result is positive, the MDSS produces two outputs that BioPlex 2200 can display in its User Interface. The first output is a text result containing the specific disease association(s) results. The second output is a graph of the specific disease association(s) and the patient's analyte results. | | | Tissue of Origin Test K080896 | Bioplex 2200 Medical Decision Support Software K043341 | | CHARACTERISTIC | | | | Sample Preparation | Frozen biopsy tissues | Serum or plasma | | Required Platform | Affymetrix GeneChip® Scanner GCS3000Dx, or equivalent | BioPlex 2200 Multi-Analyte Detection System | | Output | Similarity of RNA expression patterns found in tumor specimens to 15 known tissues of origin | Results of MDSS analysis fall into one of three categories: Negative, No Association, or Association with Disease | | Testing Environment | Professional use, CLIA High Complexity Laboratory | Professional use, CLIA High Complexity Laboratory | | Precision | Reproducibly studies were conducted at four sites with multiple specimens (n = 3 or n = 6) from all 15 tissue types offered on the Pathwork Tissue of Origin Test panel (n = 60 specimens across all tissue types). Aliquots from each specimen were processed, scanned, and interpreted by all four sites, and each site was compared to each other. The overall site- to-site concordance among the four sites for Tissue of Origin Test results was approximately 93%. | Reproducibly studies were conducted at three sites with 11 eleven panel samples and three lots of reagents. Each sample was tested in duplicate, two "runs" per day for 10 days. The data were analyzed for intra-assay precision and inter-assay precision. For intra-assay precision, the percent coefficients of variation (%CVs) ranged from 1.7% to 11.1% across the three sites. For inter-assay precision, the %CVs ranged from 2.8% to 12.8% across the three sites. | | Accuracy | The accuracy, defined as positive and negative percent agreement against the available diagnosis was as follows. The positive percent agreement across all 15 tissues was approximately 90% The negative percent agreement across all 15 tissues was approximately 99%. | Percent agreements of the MDSS outputs when a specific positive antibody was present, to the available diagnosis, ranged from 71% to 100%. | | Interfering Substances | Studies were conducted that evaluated the effect from potential interfering substances found in biopsy specimens, such as adipose tissue, RNases, fibrous tissue, and necrotic tissue. The data showed that there was no effect from high levels of adipose tissue (as found in breast specimens), fibrous tissue (as found in skin specimens), or necrotic tissue, when up to 20% of the biopsy specimen. The test demonstrated adequate performance with pancreas- related specimens, although performance is lower than for other tissues on the panel. The lower performance is ostensibly due to elevated levels of RNases in these specimens. | No significant interference was found from the following substances when challenges were made at high concentrations: Substance Concentration Hemoglobin ≤500 mg/dl Bilirubin (unconjugated) ≤ 20 mg/dl Triglycerides ≤ 3000 mg/dl Protein (total) ≤ 12 g/dl Cholesterol ≤ 500 mg/dl Red blood cells ≤ 0.4% concentrate Gamma-globulin ≤2.5 g/dl Ascorbic acid ≤ 3.0 mg/dl | ## Similarities/Differences between the Tissue of Origin Test and the Predicate {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Pathwork Diagnostics. The logo consists of a stylized graphic of a winding road or path on the left, followed by the word "Pathwork" in a bold, sans-serif font. Below "Pathwork" is the word "Diagnostics" in a smaller font size. 1196 Borregas Avenue Suite 200 Sunnyvale, CA 94089 # Similarities/Differences (continued) {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Pathwork Diagnostics. The logo consists of a stylized graphic of a winding road or path on the left, followed by the word "Pathwork" in a bold, sans-serif font. Below "Pathwork" is the word "Diagnostics" in a smaller font size. 1196 Borregas Avenue Suite 200 Sunnwale, CA 94089 ## 807.92 (b)(1): Brief Description of Non-clinical data Studies were conducted that evaluated the effect from potential interfering substances found in biopsy specimens, such as adipose tissue, RNases, fibrous tissue, and necrotic tissue. The data showed that there was no effect from high levels of adipose tissue (as found in breast specimens), fibrous tissue (as found in skin specimens), or necrotic tissue up to 20% of the biopsy specimen. The Tissue of Origin Test demonstrates adequate performance with pancreas-related specimens, although performance is lower than for other tissues on the TOO panel. The lower performance is ostensibly due to elevated levels of RNases in these specimens. Reproducibly studies were conducted at four sites with multiple specimens (n = 3 or n = 6) from all 15 tissue types offered on the Pathwork Tissue of Origin Test panel (n = 60 specimens across all tissue types). Aliquots from each specimen were processed, scanned, and interpreted by all four sites, and each site was compared to each other. The overall site-to-site concordance among the four sites for Tissue of Origin Test results was approximately 93%. ## 807.92 (b)(2): Brief Description of Clinical Data The clinical study was performed at four laboratory sites and included 545 frozen specimens. The accuracy, defined as positive and negative percent agreement against the available diagnosis was as follows. The positive percent across all 15 tissues was 89.4 (487/545), with a confidence interval of 86.5% to 91.8%. The negative percent agreement across all 15 tissues was 99.6% (507/509) with a confidence interval of 98.6% to 100.0%. ### 807.92 (b)(3): Conclusions from Clinical Testing The results of the clinical validation demonstrated that the Pathwork Tissue of Origin Test is safe and effective for its intended use. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font. The text is centered on the page. The text is likely part of a document or letterhead. Public Health Service Image /page/5/Picture/12 description: The image shows a logo for the Department of Health & Human Services USA. The logo features a stylized abstract design with three curved lines that resemble a person. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the design. Pathwork Diagnostics, Inc. c/o Ms Erika B. Ammirati Regulatory Consultant 1196 Borregas Ave, Suite 200 Sunnyvale, CA 94089 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Re: k080896 Trade/Device Name: Pathwork® Tissue of Origin Test Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: II Product Code: OIW Dated: July 21, 2008 Received: July 22, 2008 JUL 30 ... Dear Ms. Ammirati: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. The Office of In Vitro Diagnostic Device Evaluation and Safety has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear under the Indications for Use section of the device's labeling and the patient test report: 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. {6}------------------------------------------------ Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to nroceed to the market. This letter will allow you to begin marketing your device as described in your Scction 510(k) premarket notification if the limitation statement described above is added to your labeling. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). If you desire specific information about the application of other labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. Dame Zurch for \$teven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ ## Indications for Use 510(k) Number (if known): k080896 Device Name: Pathwork® Tissue of Origin Test FDA's Statement of the Indications For Use for device: 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, hepatoccllular, 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. Prescription Use _ كما (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Mana Mchon **Division Sign-Off** Office of In Vitro Diagno Device Evaluation and Sa 510(k) K080896

PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST

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PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST

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