(121 days)
Not Found
Unknown
The description mentions "analytics" and "System Software" that performs "data quality control and analysis" and generates "Similarity Scores" based on comparing RNA expression patterns to a database. While this involves data processing and comparison, the specific algorithms used are not detailed enough to definitively confirm or deny the use of AI/ML. The term "analytics" is broad and could encompass various statistical or algorithmic methods, not necessarily AI/ML.
No
The device is described as an in vitro diagnostic test that measures the similarity of RNA expression patterns in a patient's fresh-frozen tumor to a database of known tumor types to aid in diagnosis, not to treat or cure a disease.
Yes
The "Intended Use / Indications for Use" section states that the test result is "intended for use in the context of the patient's clinical history and other diagnostic tests evaluated by a qualified clinician," indicating its role in diagnosis. It also mentions "diagnosed according to then current clinical and pathological practice" within the context of the database.
No
The device description explicitly states it is a "microarray and analytics 'kit'" and lists hardware components like "Pathchip microarrays" and "Tissue of Origin Test Reagents" as part of the kit. While it includes software for analysis, it is not solely software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to measure the degree of similarity between the RNA expression pattern in a patient's tumor and a database of tumor samples. This analysis is performed in vitro (outside the body) on a biological specimen (fresh-frozen tumor). The results are intended for use in the context of the patient's clinical history and other diagnostic tests, which is a typical characteristic of an IVD.
- Device Description: The description explicitly states it is a "microarray and analytics 'kit'" and includes components like microarrays, reagents for specimen processing and RNA extraction, and software for data analysis. These are all components used in in vitro diagnostic procedures.
- Specimen Type: The test is performed on "fresh-frozen tumor" specimens, which are biological samples analyzed in vitro.
- Performance Studies: The performance studies describe analyzing specimens and comparing results against available diagnoses, which is consistent with the evaluation of an IVD's accuracy.
- Predicate Device: The predicate device listed (K043341; BioPlex 2200 Medical Decision Support software (MDSS) on the BioPlex 2200 Multi-Analyte Detection System) is also an IVD.
The core function of the device is to analyze biological material (RNA from a tumor specimen) in vitro to provide diagnostic information (similarity to known tumor types). This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
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.
Product codes
NVI, OIW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tumor specimens (poorly differentiated, undifferentiated and metastatic cases). Specifically: bladder, breast, colorectal, gastric, hepatocellular, kidney, non-small cell lung, ovarian, pancreatic, prostate, and thyroid carcinomas, melanoma, testicular germ cell tumor, non-Hodgkins lymphoma, and soft tissue sarcoma.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional use, CLIA High Complexity Laboratory
Description of the training set, sample size, data source, and annotation protocol
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).
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Reproducibility 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%.
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%.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive percent agreement across all 15 tissues was 89.4 (487/545), with a confidence interval of 86.5% to 91.8%.
Negative percent agreement across all 15 tissues was 99.6% (507/509) with a confidence interval of 98.6% to 100.0%.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3100 Amphetamine test system.
(a)
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.(b)
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).
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
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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