(510 days)
Not Found
No
The device description and performance studies focus on a standard immunoassay and PCR method for measuring PSA levels and calculating a linear slope. There is no mention of AI or ML algorithms being used for data analysis, interpretation, or risk prediction. The risk prediction is based on a calculated slope value and statistical analysis (Kaplan-Meier, Cox regression).
No
Explanation: The device is an in-vitro diagnostic assay used as a prognostic marker to identify patients at reduced risk for recurrence of prostate cancer. It does not provide any treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "NADiA® ProsVue™ is an in-vitro diagnostic assay." It is used as a prognostic marker to aid in identifying patients at reduced risk for recurrence of prostate cancer.
No
The device description clearly states that the device is an in-vitro diagnostic assay that utilizes reagents, microparticles, and a PCR instrument (Applied Biosystems® 7500 Fast Dx Real-Time PCR instrument) to perform the assay. While it includes "ProsVue Software" for calculating the slope, the core function and components involve physical reagents and hardware beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "NADiA® ProsVue™ is an in-vitro diagnostic assay for determining rate of change of serum total prostate specific antigen over a period of time (slope, pg/mL per month)."
This statement clearly identifies the device as an in-vitro diagnostic assay.
N/A
Intended Use / Indications for Use
NADiA® ProsVue™ is an in-vitro diagnostic assay for determining rate of change of serum total prostate specific antigen over a period of time (slope, pg/mL per month). The NADiA® ProsVue™ assay is performed for patients having less than 0.1 ng/mL serum total PSA values (determined by standard-of-care assays that are FDA approved/cleared) in the first sample collected more than 6 weeks after radical prostatectomy. ProsVue™ slope is indicated for use as a prognostic marker in conjunction with clinical evaluation as an aid in identifying those patients at reduced risk for recurrence of prostate cancer for the eight year period following prostatectomy.
The NADiA® ProsVue™ assay is not intended for the diagnosis or for the monitoring of prostate cancer.
Product codes (comma separated list FDA assigned to the subject device)
OWM
Device Description
ProsVue™ is a two-site immunoassay utilizing an assay specific synthetic DNA sequence as a label with a PCR detection method. Calibrators, controls and samples react with a reagent containing a monoclonal PSA-specific antibody labeled with an assay-specific double-stranded DNA sequence. Then a reagent of paramagnetic microparticles coupled to a monoclonal antibody specific for another site on PSA is added and allowed to react to form a specific sandwich complex with PSA. After washing the particles to remove reactants, a reagent containing a heat-stable polymerase, specific primers, nucleotides, and a fluorescent dye is added to the washed microparticles. An Applied Biosystems® (AB) 7500 Fast Dx Real-Time PCR instrument is utilized to detect the presence of the monoclonal PSA-specific antibody labeled with an assay specific DNA sequence indicating the levels of PSA in the samples. PSA values of controls and samples are calculated in pg/mL from a calibrator dose-response plot. ProsVue slope is calculated using ProsVue Software from the calculated PSA concentrations of three patient samples collected between six weeks and 20 months post radical prostatectomy.
The assay is made up of Reporter Antibody Reagent, Target Capture Reagent. PCR Reagent, Calibrators, Directions for Use (DFU) and ProsVue Software. Wash Reagent, Sample Diluent, and a three-level assayed control set are provided separately. ProsVue users initially receive the DFU and ProsVue software, which provide instructions and quality control support for the process of sample scheduling, collection and storage. When samples are ready for testing, the user contacts Iris Molecular Diagnostics (IMD), and IMD ships the required reagents.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Prostate
Indicated Patient Age Range
41 to 79 years
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
To evaluate the prognostic capability of ProsVue™ linear slope to identify prostate cancer patients at reduced risk of prostate cancer recurrence following radical prostatectomy (RP). 304 patients were selected using a case-cohort study design. Patients meeting the study entry criteria were acquired from four clinical sites where each patient's clinical status ("Stable" or "Recurrence") was documented. Samples used were from men age 41 to 79 years with documented prostate cancer treated via radical prostatectomy with curative intent. Caucasian (88.8%), African-American (8.2%), Asian (2.0%) and patients of unknown race (1.0%) achieving post-RP total PSA values 2 pg/mL/month (HR = 18.3 with 95% Cl: 10.6 to 31.8; p 2 pg/mL/month.
- Median time to recurrence in patients with ProsVue slope ≤ 2 pg/mL/month was > 17.6 years versus 4.8 years for patients with ProsVue slope > 2 pg/mL/month.
- Multivariate Cox proportional hazards regression analysis adjusted for pre-prostatectomy PSA value, pathologic disease stage, and Gleason score found ProsVue linear slope remained a highly significant and independent predictor of risk for prostate cancer recurrence with a HR of 9.8 (95% Cl: 5.4 to 17.8, p 2 pg/mL/month.
- Among subjects who had "Stable" through at least 8 years of follow-up, 94.6% (227/240) subjects had slope ≤ 2 pg/mL/month.
- Positive likelihood ratio (PLR) was 13.3 (95% CI: 7.7 – 23.0).
- Negative likelihood ratio (NLR) was 0.297 (95% Cl: 0.201 - 0.440).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive predictive value (PPV): 78.0% with 95% Cl: 65.3 - 87.7%
Negative predictive value (NPV): 92.7% with 95% CI: 88.6 - 95.6%
PLR: 13.3 (95% CI: 7.7 – 23.0)
NLR: 0.297 (95% Cl: 0.201 - 0.440)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Agendia BV MammaPrint® (K062694)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.6040 Gene expression profiling test system for breast cancer prognosis.
(a)
Identification. A gene expression profiling test system for breast cancer prognosis is a device that measures the ribonucleic acid (RNA) expression level of multiple genes and combines this information to yield a signature (pattern or classifier or index) to aid in prognosis of previously diagnosed breast cancer.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis.” See § 866.1(e) for the availability of this guidance document.
0
Iris Molecular Diagnostics
A Division of IRIS International, Inc.
SEP 2 0 2011
510(k) Summary NADiA® ProsVue™
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
1. Submitter name and address contact
Iris Molecular Diagnostics 2075 Corte del Nogal, Suite J Carlsbad, CA 92011 Telephone: (760) 795-5003 (760) 438-9943 Fax: Contact Person: Robert E. Klem, PhD Date Prepared: September 19, 2011
2. Device Name
Proprietary Name: NADiA® ProsVue™
Common Name: Immuno-PCR Assay for the Determination of Prostate Specific Antigen (PSA)
Classification Name: Prostate-specific antigen (PSA) for prognostic, recurrence risk assessment of prostate cancers
3. Predicate Device
Agendia BV MammaPrint® (K062694)
4. Device Description
ProsVue™ is a two-site immunoassay utilizing an assay specific synthetic DNA sequence as a label with a PCR detection method. Calibrators, controls and samples react with a reagent containing a monoclonal PSA-specific antibody labeled with an assay-specific double-stranded DNA sequence. Then a reagent of paramagnetic microparticles coupled to a monoclonal antibody specific for another site on PSA is added and allowed to react to form a specific sandwich complex with PSA. After washing the particles to remove reactants, a reagent containing a heat-stable polymerase, specific primers, nucleotides, and a fluorescent dye is added to the washed microparticles. An Applied Biosystems® (AB) 7500 Fast Dx Real-Time PCR instrument is utilized to detect the presence of the monoclonal PSA-specific antibody labeled with an assay specific DNA sequence indicating the levels of PSA in the samples. PSA values of controls and samples are calculated in pg/mL from a calibrator dose-response plot. ProsVue slope is calculated using ProsVue Software from the
1
calculated PSA concentrations of three patient samples collected between six weeks and 20 months post radical prostatectomy.
The assay is made up of Reporter Antibody Reagent, Target Capture Reagent. PCR Reagent, Calibrators, Directions for Use (DFU) and ProsVue Software. Wash Reagent, Sample Diluent, and a three-level assayed control set are provided separately. ProsVue users initially receive the DFU and ProsVue software, which provide instructions and quality control support for the process of sample scheduling, collection and storage. When samples are ready for testing, the user contacts Iris Molecular Diagnostics (IMD), and IMD ships the required reagents.
5. Intended Use
NADiA® ProsVue™ is an in-vitro diagnostic assay for determining rate of change of serum total prostate specific antigen over a period of time (slope, pg/mL per month). The NADiA® ProsVue™ assay is performed for patients having less than 0.1 ng/mL serum total PSA values (determined by standard-of-care assays that are FDA approved/cleared) in the first sample collected more than 6 weeks after radical prostatectomy. ProsVue™ slope is indicated for use as a prognostic marker in conjunction with clinical evaluation as an aid in identifying those patients at reduced risk for recurrence of prostate cancer for the eight year period following prostatectomy.
The NADiA® ProsVue™ assav is not intended for the diagnosis or for the monitoring of prostate cancer.
6. Assay Performance
Measuring Interval
From 0.65 pg/mL to 100 pg/mL
Sensitivity
Limit of blank, limit of detection, and limit of quantitation were determined with the Clinical Laboratory Standards Institute (CLSI) EP17-A guideline.
| Limit of Blank (LOB): | 0.17 pg/mL |
|---|---|
| Limit of Detection (LOD): | 0.27 pg/mL |
| Limit of Quantitation (LOQ): | 0.65 pg/mL |
Linearitv
Linearity was evaluated in accordance with the CLSI EP06-A guideline. For total PSA by NADiA® ProsVue™, the method has been demonstrated to be linear from 0.65 pg/mL to 100 pg/mL with deviation from linearity less than 24%.
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Precision
Three male serum pools were analyzed in accordance with CLSI EP5-A2. Samples were analyzed in duplicate determinations at two sites, by three operators using two AB 7500 Fast Dx instruments and two reagent lots. Forty assays were performed at the first site by two operators. Each operator performed one run per day, alternating between reagent lots, over a course of 20 days. At the second site, a single operator performed 2 runs a day, one on each reagent lot, for 5 days. The two sites combined yielded a total of 50 assays over a period of 25 non-consecutive days. Two statistical analyses were performed to analyze contribution of components of variation to total variation: one for estimation of within-run, between-run, and betweenday components of variation; and a second for estimation of within-run, between-run, and between-lot components of variation. Additionally, site-specific results were calculated. The following results were obtained:
| Measure | Low Sample | Intermediate Sample | High Sample |
|---|---|---|---|
| Mean (pg/mL) | 3.79 | 24.1 | 69.1 |
| Within-run variation | |||
| SD | 0.34 | 1.74 | 5.97 |
| %CV | 9.0 | 7.2 | 8.6 |
| Between-run | |||
| SD | 0.34 | 0.81 | 3.22 |
| %CV | 9.0 | 3.4 | 4.7 |
| Between-day | |||
| SD | 0.32 | 1.23 | 2.83 |
| %CV | 8.3 | 5.1 | 4.1 |
| Total variation | |||
| SD | 0.58 | 2.28 | 7.35 |
| %CV | 15.2 | 9.4 | 10.6 |
A. Within-run, between-run, and between-day variation
Components of variation estimated only include within-run, between-run, and betweenday in this analysis.
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B. Within-run, between-run, and between-lot variation
| Measure | Low
Sample | Intermediate
Sample | High
Sample |
|----------------------|---------------|------------------------|----------------|
| Mean (pg/mL) | 3.79 | 24.1 | 69.1 |
| Within-run variation | | | |
| SD | 0.21 | 0.42 | 1.35 |
| %CV | 5.6 | 1.7 | 2.0 |
| Between-run | | | |
| SD | 0.47 | 1.48 | 4.37 |
| %CV | 12.5 | 6.1 | 6.3 |
| Between-lot | | | |
| SD | 0.15 | 0.28 | 0.00 |
| %CV | 4.0 | 1.1 | 0.0 |
| Total variation | | | |
| SD | 0.75 | 1.71 | 4.57 |
| %CV | 14.0 | 6.5 | 6.6 |
Components of variation estimated only include within-run, between-run, and betweenlot in this analysis.
The between-lot imprecision was not more than 4.0%.
C. Site-specific results
| Site(s) | Days | Data
points | Sample # | Mean
(pg/mL) | Between-site %CV |
|---------|--------|----------------|----------|-----------------|------------------|
| 1 | 20 | 80 | 1 | 3.96 | |
| 1 | 20 | 80 | 2 | 24.4 | |
| 1 | 20 | 80 | 3 | 70.7 | |
| 2 | 5 | 20 | 1 | 3.11 | |
| 2 | 5 | 20 | 2 | 23.0 | |
| 2 | 5 | 20 | 3 | 62.5 | |
| 1 & 2 | 51 + 5 | 40 | 1 | 3.55 | 13.7 |
| 1 & 2 | 51 + 5 | 40 | 2 | 24.2 | 7.3 |
| 1 & 2 | 51 + 5 | 40 | 3 | 66.9 | 9.6 |
1 5 + 5 = first 5 days at site 1 and entire 5 days at site 2
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Interfering Substances
Elevated concentrations of blood constituents and drugs were added to serum samples containing PSA at 3 and 50 pg/mL and assayed in quadruplicate with the ProsVue™ assay. The substances added and the highest concentrations tested are listed in the tables below. At the concentrations listed, these substances showed less than 10% interference in assay results.
Interference by blood constituents
| Bilirubin, conjugated | 30 mg/dL |
|---|---|
| Cholesterol | 500 mg/dL |
| Creatinine | 5.0 mg/dL |
| Hemoglobin | 200 mg/dL |
| Immunoglobulin G | 6 g/dL |
| Triglycerides | 1000 mg/dL |
| Urea | 260 mg/dL |
| Uric acid | 23.5 mg/dL |
Interference by drugs
| 10-hydroxynortriptyline | 700 ng/mL |
|---|---|
| 5-Fluorouracil | 390 µg/mL |
| Acetaminophen | 200 µg/mL |
| Ampicillin | 53 µg/mL |
| Ascorbic acid | 60 µg/mL |
| Biotin | 50 ng/mL |
| Caffeine | 60 µg/mL |
| Carbamazepine | 30 µg/mL |
| Chloramphenicol | 50 µg/mL |
| Cimetidine | 20 µg/mL |
| Ciprofloxacin | 10 µg/mL |
| Cisplatin | 12 µg/mL |
| Cotinine | 1.9 µg/mL |
| Cyclophosphamide | 375 µg/mL |
| Dextran-40 | 60 mg/mL |
| Digoxin | 6.1 ng/mL |
| Doxorubicin | 240 ng/mL |
| Erythromycin | 60 µg/mL |
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| Ethanol | 4 mg/mL |
|---|---|
| Ethosuximide | 250 µg/mL |
| Flutamide | 500 ng/mL |
| Furosemide | 60 µg/mL |
| Gentamicin | 10 µg/mL |
| Heparin sodium | 3 U/mL |
| Ibuprofen | 500 µg/mL |
| Leuprolide acetate | 200 ng/mL |
| Lidocaine | 12 µg/mL |
| Lithium | 22.5 µg/mL |
| Methotrexate | 910 µg/mL |
| Paclitaxel | 6.5 µg/mL |
| Pamidronate | 9 µg/mL |
| Phenytoin | 50 µg/mL |
| Prednisone | 300 ng/mL |
| Primidone | 40 µg/mL |
| Prochlorperazine | 1 µg/mL |
| Salicylic acid | 600 µg/mL |
| Sulfamethoxazole | 400 µg/mL |
| Tamoxifen | 1.5 µg/mL |
| Trimethoprim | 40 µg/mL |
| Valproate sodium | 500 µg/mL |
| Vancomycin | 100 µg/mL |
| Vinorelbine | 1.2 µg/mL |
7. Stability of PSA in serum at 2 pa/ml/month [n=59]),
Image /page/7/Figure/3 description: This image is a survival plot showing the probability of stability over time in years. The x-axis represents time in years, ranging from 0 to 20. The y-axis represents the probability of stability, ranging from 0 to 1.000. There are two lines on the plot, one solid and one dashed, representing different groups or conditions.
The Kaplan-Meier estimates of the 8-year probability of "Stable" were 95.9% (95% CI: 93.4 - 98.4%) for the patients with ProsVue Slope ≤ 2
8
pg/mL/month and 37.3% (95% Cl: 25.0 - 49.6%) for the patients with ProsVue Slope > 2 pq/mL/month. Median time to recurrence in the patients with ProsVue slope ≤ 2 pg/ml/month was > 17.6 years versus 4.8 years for patients with ProsVue slope > 2 pg/ml/month.
Further investigation with Cox proportional hazards regression analysis used to evaluate the association between ProsVue linear slope and prostate cancer recurrence status in a univariate analysis (can be interpreted as stand alone performance) indicated that the patients with ProsVue Slope≤2 pg/mL/month were 18.3 times more likely to be "Stable" than those with ProsVue Slope>2 pg/mL/month (HR = 18.3 with 95% Cl: 10.6 to 31.8; p 2.0 pg/ml/month vs. ≤ 2.0 pg/ml/month) | 18.332 | 10.6 - 31.8 | 2.0 pg/ml/month vs. ≤ 2.0
pg/ml/month) | 9.824 | 5.4 - 17.8 | 2 pg/mL/month (Positive Predictive Value, PPV) and probability to remain with clinical status "Stable" through at least 8 years for the subjects with slope ≤ 2 pg/mL/month (Negative Predictive Value, NPV) were calculated from the clinical study results (n=304). Table 3 presents a 2 x 2 table of the ProsVue classification based on the slope outcome and to the clinical status of patients as "Stable" or "Recurrence" following 8 years (row and column totals are displayed).
Table 3: 2x2 Table of ProsVue™ classification vs. Reference Clinical status (N=304)
| Reference Clinical Status | ||||
|---|---|---|---|---|
| Recurrence | Stable | Totals | ||
| ProsVue | Slope > 2 pg/mL/month | 46 | 13 | 59 |
| Slope ≤ 2 pg/mL/month | 18 | 227 | 245 | |
| Totals | 64 | 240 | 304 |
Among subjects who had "Recurrence" during 8 years of follow-up, 71.9% (46/64) subjects had slope > 2 pg/mL/month and among the subjects who had "Stable" through at least 8 years of follow-up, 94.6% (227/240) subjects had slope ≤ 2 pg/mL/month.
Positive likelihood ratio (PLR) was 13.3 with 95% CI: 7.7 – 23.0 and negative likelihood ratio (NLR) was 0.297 with 95% Cl: 0.201 - 0.440.
In these data, probability of "Recurrence" regardless of the values of the ProsVue slope was 21.0% (64/304); PPV was 78.0% with 95% Cl: 65.3 - 87.7% and NPV was 92.7% with 95% CI: 88.6 - 95.6%.
Because the estimates of PPV and NPV depend on the probability of "Recurrence" among all subjects (prevalence of clinical status "Recurrence"), Table 4 presents estimates of PPV and NPV calculated for various levels of prevalence of "Recurrence".
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| Prevalence | PPV | NPV |
|---|---|---|
| (%) | (%) | (%) |
| 10 | 59.7 | 96.8 |
| 15 | 70.1 | 95 |
| 20 | 76.9 | 93.1 |
| 25 | 81.6 | 91.0 |
| 30 | 85.1 | 88.7 |
| 35 | 87.8 | 86.2 |
Table 4: Estimates of PPV and NPV calculated for various levels of prevalence (%) of clinical recurrence.
A subgroup analysis was performed on data from 20 patients with at least one post-RP PSA value ≥ 300 pg/mL, but who remained stable throughout at least 8 years of follow-up. ProsVue slope correctly classified 11 of the 20 patients as "at reduced risk for recurrence" (ProsVue slope ≤ 2 pg/mL/month).
9. Software
Software is provided as an accessory to the ProsVue™ assay kit. Its purpose is to reduce the risk of errors in the use of appropriate serum samples and calculating assay results.
The ProsVue™ software identifies serum samples with invalid collection intervals and calculates the equation of the calibration line. PSA concentration (pg/mL) of patient samples and assay controls, patient ProsVue slope (pg/mL/month), and patient risk category. ProsVue software generates a report that includes the ProsVue slope (in pq/mL/month) and whether that slope categorizes a patient as being at "reduced risk" or "not at reduced risk" of prostate cancer recurrence.
ProsVue™ software is an Excel Add-In containing calculation spreadsheets, Userforms, and code modules. Its User Interface consists of Userforms and dialog boxes consistent with those found in standard Excel Add-Ins. The User Interface allows entry and validation of sample identifiers and dates, plate map set-up, selection of a raw data (.csv) file to be analyzed, and viewing/printing of assay results. All sample and assay run requirements, as provided in the ProsVue™ Directions for Use are applied in the software to ensure valid results.
Conclusion
NADiA® ProsVue™ is substantially equivalent to the predicate device, the Agendia BV MammaPrint® (K062694). No new issues of safety or effectiveness have been raised.
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Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is depicted in black, and the text is also in black. The background of the logo is white.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Iris Molecular Diagnostics c/o Robert E. Kiem. Ph.D. Vice President of Product Development 2075 Corte Del Nogal, Suite-J Carlsbad, CA 92011
SEP 2 0 2011
રિભ: 1101182 Trade/Device Name: NADiA® Pros Vue™ Regulation Number: 21 CFR 866.6040 Regulation Name: Gene expression profiling test system for breast cancer prognosis Regulatory Class: II Product Code: OWM Dated: September 5, 2011 Received: September 7, 2011
Dear Dr. Klem:
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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition. FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA is 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
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Page 2 - Robert E. Klem. Ph.D.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Maria m Chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K101185
Device Name: NADiA® ProsVue™
Indications for Use:
NADiA® ProsVue™ is an in-vitro diagnostic assay for determining rate of change of serum total prostate specific antigen over a period of time (slope, pg/mL per month). The NADiA® ProsVue™ assay is performed for patients having less than 0.1 ng/mL serum total PSA values (determined by standard-of-care assays that are FDA approved/cleared) in the first sample collected more than 6 weeks after radical prostatectomy. ProsVue™ slope is indicated for use as a prognostic marker in conjunction with clinical evaluation as an aid in identifying those patients at reduced risk for recurrence of prostate cancer for the eight year period following prostatectomy.
The NADiA® ProsVue™ assay is not intended for the diagnosis or for the monitoring of prostate cancer.
Prescription Use) × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Reena Philip
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
S10K K101185
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