(90 days)
AuraTek FDP is a rapid one-step gold dye particle lateral flow immunoassay indicated for the in vitro qualitative measurement of fibringen and fibrinogen degradation products (FDP) in human urine, to be used with standard cystoscopic examination to aid in the management of patients with a history of bladder cancer.
AuraTek FDP is a one-step gold dye particle immunoassay on a porous carrier. Mobile purple-red dye particles labeled with anti-FDP and fibrinogen antibody and immobile capture anti-FDP and fibringgen antibodies are coated as discrete zones on the porous carrier. In addition a test control zone with antimurine IgG (Reaction Control 2) is coated on the carrier. A sample placed on the device is absorbed by the porous carrier. The rehydrated colored sol particles move through the porous carrier to the capture anti-FDP and then to the anti-murine IgG. If the sample contains FDP and/or fibrinogen, the antibodylabeled sol particles will bind in a sandwich-type reaction to the capture anti-FDP and fibrinogen antibody producing a purple-red dot in the test result window. With a negative sample, the white test result window remains unchanged at the time of reading. AuraTek FDP has the unique feature that the test run validity is double-checked with the appearance and disappearance of color in the Reaction Control 1 window and development of a purple-red dot in the Reaction Control 2 window.
Here's a breakdown of the acceptance criteria and the study details for the AuraTek FDP device, based on the provided document:
Acceptance Criteria and Device Performance
The acceptance criteria are not explicitly stated as distinct thresholds in the document. Instead, the device's performance is presented in comparison to existing methods (cytology and hemoglobin dipstick) and against general clinical expectations for accuracy in bladder cancer monitoring. The key performance metrics are Sensitivity and Specificity.
Here's a table summarizing the reported device performance and implicitly, the targets it aims to meet or exceed:
| Metric | Acceptance Criteria (Implied/Compared to) | Reported Device Performance (AuraTek FDP) |
|---|---|---|
| Sensitivity | Better than cytology (35%) | 68% (All Stages), 100% (Invasive T2, T3, T4) |
| Specificity | 80% (Comparable to Bard BTA) | 96% (Healthy Subjects), 80% (Cystoscopy negative patients with history of bladder cancer) |
| Limit of Detection | - | 30 ng Fibrinogen Equivalents (FE) / ml |
| Reproducibility | Qualitative agreement | Total qualitative agreement at each control level |
| High Dose Hook Effect | No hook effect up to 2000 ng FE/ml | No hook effects seen at concentrations up to 2000 ng FE/ml |
| Interfering Substances | No interference at specified concentrations | Many substances tested without interference. Whole blood and plasma may cause positive interference at levels > 0.0156% vol/vol. |
Study Details
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Clinical Sensitivity Study: 192 patients with a history of bladder cancer undergoing cystoscopic examination.
- 79 patients with confirmed bladder tumors (positive cystoscopy with confirmatory biopsy).
- 113 patients with negative cystoscopy results (used for specificity analysis).
- Specificity Study (Healthy Subjects): 73 healthy subjects.
- Specificity Study (Non-Bladder Cancer Urological Disease): 232 subjects with various non-bladder cancer urological diseases.
- Clinical Sensitivity Study: 192 patients with a history of bladder cancer undergoing cystoscopic examination.
- Data Provenance: The study was a "multi-center study" involving "a general urology practice." While specific countries are not mentioned, the context of a 510(k) submission to the FDA suggests the data would be primarily from the United States. The study is prospective as it involved patients "undergoing cystoscopic examination," implying data collection at the time of follow-up.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: The ground truth for bladder cancer confirmation was established by positive cystoscopy results with confirmatory biopsy. This implies a pathologist would be involved in interpreting the biopsy and a urologist in performing the cystoscopy. Specific years of experience are not mentioned, but these are standard clinical practices performed by qualified medical professionals.
4. Adjudication Method
- The document implies that the ground truth for cancer diagnosis was established by confirmatory biopsy following cystoscopy. This is a definitive diagnostic method, not typically requiring additional adjudication among experts in the same way imaging interpretations might. The mention of "positive cystoscopy results with confirmatory biopsy" suggests a definitive, pathological diagnosis. Therefore, a specific adjudication method (like 2+1 or 3+1) among multiple readers of the same data type isn't detailed, as the biopsy serves as the ultimate diagnostic confirmation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance.
- The study compares the performance of the AuraTek FDP device to standard clinical methods (cytology and hemoglobin dipstick) directly, not as an AI-assisted tool for human readers. It's a standalone device performance study.
6. Standalone Performance Study
- Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The entire "Summary of Studies" section (1.7) details the performance of the AuraTek FDP device in isolation, evaluating its sensitivity, specificity, reproducibility, high dose hook effect, and interference from various substances. The reported sensitivity and specificity values are for the device itself.
7. Type of Ground Truth Used
- The primary ground truth for the presence of bladder cancer in the clinical sensitivity study was Pathology (confirmatory biopsy following positive cystoscopy).
- For the specificity analyses, ground truth was derived from "healthy subjects," "cystoscopy negative patients with a history of bladder cancer," and patients diagnosed with "non-bladder cancer urological disease" (presumably confirmed by standard clinical diagnostic procedures relevant to their conditions).
8. Sample Size for the Training Set
- Not applicable / Not explicitly stated. This device is a rapid immunoassay (lateral flow immunoassay), not an AI/machine learning device that typically requires a large 'training set' in the conventional sense. The "training" of such a device involves optimization of its chemical and physical components (e.g., antibody concentrations, membrane properties) during its development, rather than a data-driven algorithmic training process. The document describes analytical validation and clinical performance studies, not an AI model's training phase.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As explained in point 8, this is not an AI/machine learning device. Therefore, there isn't a "training set" with ground truth in the context of an algorithm learning from data. The device's performance is driven by its biological and chemical design (monoclonal antibodies, gold dye particles, etc.).
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Property of Concession Comments of Children Comments of Children
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APR 30 1997
AuraTek FDP 510(k) #K970353
510(k) SUMMARY
机制
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1.0 510(k) Summary
1.1 General Information
| Date Prepared: | April 28, 1997 |
|---|---|
| Device Generic Name: | AuraTek FDP |
| Device Trade Name: | AuraTek FDP |
| Applicant's Name and Address: | Organon Teknika, B.V.Veedijk 582300 Turnhout, Belgium |
| Authorized representative in the U.S.: | PerImmune, Inc.1330 Piccard DriveRockville, MD 20850-4396Tel: (301) 258-5200Contact: Fedora Daye Contreras |
| Establishment Registration Number: | 1119752 |
| 510(k) Premarket Notification Number: | K970353 |
1.2 Indications for Use
AuraTek FDP is a rapid one-step gold dye particle lateral flow immunoassay indicated for the in vitro qualitative measurement of fibringen and fibrinogen degradation products (FDP) in human urine, to be used with standard cystoscopic examination to aid in the management of patients with a history of bladder cancer.
Device Classification 1.3
AuraTek FDP is a bladder tumor marker test system-monitoring which has been reclassified as a Class II (Performance standards) device, product code 82 MMW.
1.4 Background Information
Cancer of the bladder is a disease with high prevalence among men in the U.S. (4th and ninth respectively among malignant diseases) and a high rate of recurrence (estimated to be 80%). Consequently, close follow-up of bladder cancer patients on a regularly scheduled basis is essential. The standard practice for follow-up of patients with a history of bladder cancer involves the use of an invasive diagnostic procedure, transurethral cystoscopy, in which the urothelium is visually inspected with a flexible or rigid endoscope.
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Although there have been many attempts to develop efficient and reliable non-invasive diagnostic tests for bladder cancer, the urinary cytological examination remains the current clinical standard. However, cytology suffers from a limited sensitivity' (approximately 35%), particularly in low grade and low stage disease. In addition, cytology is costly, requires a specialized clinical laboratory and the results are not available to the urologist during the office visit by the bladder cancer patient.
Hemoglobin dipstick may be used as a diagnostic aid, but lacks both sensitivity and specificity for bladder turnors. In addition, a single instance of microhematuria may be attributable to a variety of causes 2. A wide range of alternative markers and procedures have been proposed, including flow cytometry, QFIA2, M344 antigen1, nuclear matrix protein', bladder tumor associated antigen (BTA), and autocrine motility factor'. The acceptance of alternative markers has been limited due to lack of efficacy, high expense, and test complexity. It would be useful, therefore, for the urologist to have available a rapid, point-of-care, diagnostic test that could offer high sensitivity, convenience, and rapid results to support the cystoscopic examination of bladder cancer patients.
Previously published studies have shown that elevated urinary fibrin(ogen) degradation products (FDP) are associated with the presence of bladder cancer. In particular, McCabe, et al. found elevated urinary fibrinogen and FDP levels in 83% of all bladder cancer patients tested using an ELISA method. Based upon this initial study, a rapid, self-contained immunoassay device was developed (AuraTek FDP) that is similar in principle to several over the counter urinary hCG pregnancy tests. This test employs monoclonal antibodies specific for fibrinogen and fibrin(ogen) degradation products and is designed for point-of-care use in the physician's office.
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Device Description 1.5
1.5.1 Description of Test Analyte
Fibrinogen is a protein found in blood plasma that is converted into fibrin in the process of blood clotting. Fibrinfibrinogen degradation products (FDP) are protein fragments generated by the action of the fibrinolytic system (plasmin) on fibrin and fibrinogen.
1.5.2 FDPs in Bladder Cancer
Studies have shown that increased urinary fibrinogen degradation products (FDP) levels are associated with the presence of bladder malignancy. Wajsman et al. reported findings of significantly elevated FDP levels in patients with active bladder carcinoma9. Using an ELISA procedure, McCabe et al. found elevated urinary fibrinogen and FDP levels in 83% of all bladder cancer patients tested . The same paper also reported a 98% specificity for patients with nonmalignant urological disease. Other studies have confirmed the utility of urinary fibrinogen and FDP measurement in patients with bladder carcinoma10,11,12
Tumor cells produce vascular endothelial growth factor (VEGF), which is an angiogenic factor13. Increased expression of VEGF has been associated with bladder tumors' 115. One effect of VEGF is to increase the permeability of the surrounding microvasculature. The increased permeability may lead to leakage of plasma proteins including plasminogen, and various clotting factors. The clotting factors along with other factors released by the tumor cells rapidly convert the fibrinogen into an extravascular fibrin clot. This fibrin clot will act as a provisional stroma for the tumor until being replaced by mature stroma. Plasminogen may be converted to plasmin by urokinase, the plasminogen activator in the urine produced by the kidney, as well as the tumor cells. The plasmin can then break down the fibrin deposit into fibrin degradation products or FDP's.
1.5.3 Device Design
AuraTek FDP is a one-step gold dye particle immunoassay on a porous carrier. Mobile purple-red dye particles labeled with anti-FDP and fibrinogen antibody and immobile capture anti-FDP and fibringgen antibodies are coated as discrete zones on the porous carrier. In addition a test control zone with antimurine IgG (Reaction Control 2) is coated on the carrier. A sample placed on the device is absorbed by
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the porous carrier. The rehydrated colored sol particles move through the porous carrier to the capture anti-FDP and then to the anti-murine IgG. If the sample contains FDP and/or fibrinogen, the antibodylabeled sol particles will bind in a sandwich-type reaction to the capture anti-FDP and fibrinogen antibody producing a purple-red dot in the test result window. With a negative sample, the white test result window remains unchanged at the time of reading. AuraTek FDP has the unique feature that the test run validity is double-checked with the appearance and disappearance of color in the Reaction Control 1 window and development of a purple-red dot in the Reaction Control 2 window.
Image /page/4/Figure/2 description: The image shows a diagram of a testing device with several labeled components. The components labeled are the sample port, reaction control 1, test result, reaction control 2, and ID area. The sample port is on the left side of the device, and the ID area is on the bottom.
1.6 Substantial Equivalence
The AuraTek® FDP in vitro diagnostic described in this application is substantially equivalent to a currently marketed test. The BARD BTA Rapid Urine Test, manufactured by Bard Diagnostic Sciences, Bard Urological Division is designed for the qualitative measurement of an analyte associated with the presence of bladder cancer in human urine. (See Table 1.0)
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到出張
| Table 1.0 Substantial Equivalence of AuraTek FDP with the Bard BTA Test | ||
|---|---|---|
| Test Name | AuraTek FDP | Bard BTA |
| Intended Use | AuraTek FDP is a rapid one-step gold dye particle lateralflow immunoassay indicatedfor the [ in vitro qualitativemeasurement] of fibrinogenand fibrin/fibrinogendegradation products (FDP) inhuman urine to be used withstandard cystoscopicexamination [to aid in themanagement of patients with ahistory of bladder cancer.] | The Bard BTA rapid latexagglutination test is an [ in vitro ]device intended for the[qualitative] measurement ofBladder Tumor AssociatedAnalytes in human urine [to aid inthe management of bladder cancerpatients.] |
| Sample Matrix | Urine | Urine |
| Format | Rapid lateral flowimmunoassay | Rapid latex agglutination test |
| Analyte | Fibrinogen andFibrin/Fibronogen DegradationProducts (FDP) | Bladder Tumor AssociatedAnalytes |
| Limit of Detection | 30 ng Fibrinogen Equivalents(FE) / ml | $9.8 \mu g/ml$ Bladder TumorAssociated Analytes |
| Sensitivity | 68% | 40% (from package insert) |
| Specificity | 80% | 80% (from package insert) |
1.7 Summary of Studies
Analytical Sensitivity / Limits of Detection 1.7.1
The sensitivity of AuraTek FDP is approximately 30 ng FE/ml as defined by the amount of FDP (ng FE/ml) present in urine which consistently produces a positive test result. The unit, "ng FE/ml" refers to "fibrinogen equivalents". This represents the relative immunoreactivity of fibrin(ogen) degradation products derived from a predetermined quantity of fibrinogen in plasma.
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1.7.2 Reproducibility
Qualitative reproducibility studies were conducted to determine within-day, between laboratory and between-lot variability. The within-day reproducibility study was run using a negative control sample (0 ng FE/mL), a low level control (25 ng FE/ml), and a high level control (250 ng All controls were tested using twenty replicates at each level. The other studies were FE/mL). conducted using a negative control sample (0 ng FE/mL), a low level control (65 ng FE/ml), and an intermediate level control (200 ng FE/mL). All three controls were tested in duplicate using two separate lots of devices on four separate days at four different clinical sites. All reproducibility studies demonstrated total qualitative agreement at each control level
High Dose Hook (Prozone) Effect 1.7.3
AuraTek FDP was tested using high concentration FDP specimens to assess high dose hook effects in patient samples with high concentrations of analyte. No hook effects were seen at concentrations up to 2000 ng FE/ml.
Interfering Substances 1.7.4
AuraTek FDP was performed with urine specimens containing a variety of potentially interfering substances. The tests included specimens with no detectable levels of FDP, 15 ng FE (fibrinogen equivalents)/ml and 100 ng FE/ml. Whole blood and plasma may cause positive interference with AuraTek FDP at levels greater than 0.0156% volume/volume.
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| Substance | Highest Concentration Tested | Highest Concentration with noInterference (1) |
|---|---|---|
| Hemoglobin | 225 mg/dl | 225 mg/dl |
| Albumin | 10 g/l | 10 g/l |
| Bilirubin unconjugated | 206 mg/dl | 206 mg/dl |
| Uric Acid | 250 mg/dl | 250 mg/dl |
| Disodium cromoglycate | 10 mg/l | 10 mg/l |
| Cetirizine HCl | 10 mg/l | 10 mg/l |
| Caffeine | 100 mg/l | 100 mg/l |
| Paracetamol | 500 mg/l | 500 mg/l |
| Ibuprofen | 400 mg/l | 400 mg/l |
| Acetylsalicylic Acid | 500 mg/l | 500 mg/l |
| Amoxicillin | 200 mg/l | 200 mg/l |
| Oxazepam | 25 mg/l | 25 mg/l |
| Diazepam | 20 mg/l | 20 mg/l |
| Ethanol | 2000 mg/l | 2000 mg/l |
| Desogestrel | 5 mg/l | 5 mg/l |
| Prednisone | 10 mg/l | 10 mg/l |
| Clomiphene Citrate | 50 mg/l | 50 mg/l |
| Ethinylestradiol | 5 mg/l | 5 mg/l |
| Heroin | 6 mg/l | 6 mg/l |
| Morphine | 6 mg/l | 6 mg/l |
| Tetrahydrcannabinol | 6 mg/l | 6 mg/l |
| Sodium Chloride | 100 mg/l | 100 mg/l |
| Amphetamine Sulfate | 10 mg/l | 10 mg/l |
| Chlorpromazine | 50 mg/l | 50 mg/l |
| Ascorbic Acid | 30 mg/l | 30 mg/l |
| Nicotine | 20 mg/l | 20 mg/l |
| Domperidone | 20 mg/l | 20 mg/l |
| Doxycycline | 200 mg/l | 200 mg/l |
| Methadone | 6 mg/l | 6 mg/l |
| Glucose | 10 g/l | 10 g/l |
| Red blood cells | 1 X 10⁶ / ml | 1 X 10⁶ / ml |
| White blood cells | 5 X 10⁴ / ml | 5 X 10⁴ / ml |
| Whole blood | 1% vol/vol | 0.0156% vol/vol (2) |
| Plasma | 1% vol/vol | 0.0156% vol/vol (2) |
| Serum | 1% vol/vol | 1% vol/vol |
| IgG Antibody | 6.25 mg/dl | 6.25 mg/dl |
Notes: (1) Refers to absence of both positive and negative interference. (2) Positive interference was found at a level of 0.125% vol/vol.
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Expected Results
Clinical Sensitivity
Positive urinary FDP test results may be indicative of bladder cancer in patients with a confirmed prior history of bladder cancer. A multi-center study was performed on 192 patients with a history of bladder cancer undergoing cystoscopic examination in a general urology practice. The mean age of the group was 69.1 ± 10.3 years. Seventy-three percent of the subjects were male. Subject racial distribution was 181 Caucasian subjects, 1 Asian subject, 2 African American subjects, 1 Hispanic subject, 1 Pacific Islander, 1 Indian Subconinent subject and 5 subjects of unknown racial origin. Bladder tumors were confirmed in 79 patients by positive cystoscopy results with confirmatory biopsy. The sensitivity results for the AuraTek test and urine cytology are listed in the following tables.
| Sensitivity of AuraTek FDP by Stage | |||||||
|---|---|---|---|---|---|---|---|
| DiseaseStage | Number ofSubjects | AuraTekFDPPositive | AuraTekFDP 95%ConfidenceInterval | CytologyPositive | Cytology95%ConfidenceInterval | Hemo-globinDipstick | Hemo-globinDipstick95%ConfidenceInterval |
| All Stages | n=79 | 68%(54/79) | 56.9-78.4% | 34%(27/79) | 23.9-45.7% | 41%(32/79) | 33.6-54.8% |
| Superficial(Tis, Ta,T1) | n=67 | 63%(42/67) | 50.0-74.2% | 27%(18/67) | 16.8-39.1% | 36%(28/77) | 25.7-48.1% |
| Invasive(T2,T3,T4) | n=12 | 100%(12/12) | 73.5-100% | 75%(9/12) | 42.8-94.5% | 86%(12/14) | 57.1-98.3% |
| Tis | n=6 | 67%(4/6) | 22.3-95.7% | 50%(3/6) | 11.8-88.2% | 33%(2/6) | 4.3-77.7% |
| Ta | n=45 | 62%(28/45) | 46.5-76.2% | 20%(9/45) | 9.6-34.6% | 24%(11/45) | 12.9-39.5% |
| T1 | n=16 | 63%(10/16) | 35.4-84.8% | 38%(6/16) | 15.2-64.6% | 50%(8/16) | 24.7-75.4% |
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Image /page/9/Figure/1 description: This image is a bar chart comparing the sensitivity percentages of AuraTek FDP, Cytology, and Hem. Dipstick across different categories: All, Tis-T1, T2-T4, Tis, Ta, and T1. AuraTek FDP generally shows the highest sensitivity, reaching 100% in the T2-T4 category. Cytology consistently has lower sensitivity compared to AuraTek FDP, while Hem. Dipstick varies, sometimes exceeding Cytology's sensitivity.
Sensitivity of AuraTek FDP by Stage Compared to Cytology and Hemoglobin Dipstick
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ﻢ ﺍﻟﻤﺴﺎﻫﻤﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
Image /page/10/Figure/1 description: This bar graph compares the sensitivity percentages of AuraTek FDP, Cytology, and Hemoglobin Dipstick across different categories: All, G1, G2, G3,4, and Not Assigned. For the 'All' category, AuraTek FDP has a sensitivity of approximately 68%, Cytology around 35%, and Hemoglobin Dipstick around 41%. In the G3,4 category, AuraTek FDP shows the highest sensitivity at nearly 90%, while Cytology is around 52% and Hemoglobin Dipstick is at 75%.
Sensitivity of AuraTek FDP by Grade Compared to Cytology and Hemoglobin Dipstick
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| Sensitivity of AuraTek FDP by Grade | |||||||
|---|---|---|---|---|---|---|---|
| DiseaseGrade | Number ofSubjects | AuraTekFDPPositive | AuraTekFDP 95%ConfidenceInterval | CytologyPositive | Cytology95% ConfidenceInterval | Hemo-globinDipstick | Hemo-globinDipstick95% ConfidenceInterval |
| All Grades | n=79 | 68%(54/79) | 56.9-78.4% | 34%(27/79) | 23.9-45.7% | 41%(32/79) | 29.6-52.2% |
| G1 | n=13 | 62%(8/13) | 31.6-86.1% | 8%(1/13) | 0.2-36.0% | 15%(2/13) | 1.9-45.5% |
| G2 | n=36 | 64%(23/36) | 46.2-79.2% | 28%(10/36) | 14.2-45.2% | 39%(14/36) | 23.1-56.5% |
| G3, G4 | n=22 | 86%(19/22) | 65.1-97.1% | 50%(11/22) | 28.2-71.8% | 73%(16/22) | 49.8-89.3% |
| NotAssigned | n=8 | 50%(4/8) | 15.7-84.3% | 63%(5/8) | 24.5-91.5% | 0%(0/8) | 0.0-36.9% |
Specificity
Specificity was tested on a panel of normal, healthy subjects, on urology clinic patients being cystoscopically examined for recurrence of bladder cancer or suspicion of bladder cancer, and on general urology patients with a variety of non-bladder cancer urological disease.
| Cancer Patients | |||
|---|---|---|---|
| Subject Type | Number ofSubjects | AuraTek FDPNegative | AuraTek FDP95% ConfidenceInterval |
| Healthy subjects | n=73 | 96%(70/73) | 88.5-99.1% |
| Cystoscopy negativepatients with a history ofbladder cancer | n=113 | 80%(90/113) | 72.2-87.1% |
Specificity of AuraTek FDP Healthy Subjects and Cystoscopy Negative Bladder
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| Specificity Results of AuraTek FDP on Patients with Non-Bladder CancerUrological Disease | |||||
|---|---|---|---|---|---|
| DiseaseCategory | Disease | TotalEvaluableSubjects | AuraTekFDPNegative | Specificity | 95%ConfidenceInterval |
| Total | All UrologicalDisease | 232 | 200 | 86.2 | (81.1-90.4) |
| Prostate | Benign prostatichypertrophy | 48 | 44 | 91.7 | (80.0-97.7) |
| Prostatitis | 12 | 11 | 91.7 | (61.5-99.8) | |
| Prostate cancer | 40 | 34 | 85.0 | (70.2-94.3) | |
| Misc. prostate | 1 | 1 | 100 | (2.5-100.0) | |
| Total ProstateDisease | 101 | 90 | 89.1 | (81.4-94.4) | |
| Renal | Renal stones | 12 | 10 | 83.3 | (51.6-97.9) |
| Renal cellcarcinoma | 10 | 9 | 90.0 | (55.8-99.7) | |
| Transitional cellcarcinoma | 1 | 0 | 0 | NA | |
| Misc. renal | 3 | 1 | 33.3 | (0.8-90.6) | |
| Total RenalDisease | 26 | 20 | 76.9 | (56.4-91.0) | |
| Urinary TractInfections | Urinary tractinfections | 13 | 10 | 76.9 | (46.2-95.0) |
| Bladder | Interstitialcystitis | 27 | 24 | 88.9 | (70.8-97.7) |
| Misc. bladderdisease | 5 | 3 | 60.0 | (14.7-94.3) | |
| Total BladderDisease | 32 | 27 | 84.4 | (67.2-94.7) | |
| Urodynamic | Incontinence | 25 | 23 | 92.0 | (74.0-99.0) |
| Misc.urodynamic | 3 | 3 | 100 | (29.2-100.0) | |
| TotalUrodynamicDisease | 28 | 26 | 92.9 | (76.5-99.1) | |
| Testes | Testicularcancer | 5 | 5 | 100 | (47.8-100.0) |
| Misc. testicular | 5 | 5 | 100 | (47.8-100.0) | |
| TotalTesticularDisease | 10 | 10 | 100 | (63.1-100.0) | |
| Miscellaneous | Misc. categories | 22 | 17 | 77.3 | (54.6-92.2) |
| Cancer* | Total UrologicalCancers | 56 | 48 | 85.7 | (73.8-93.6) |
- Includes subjects from all disease categories
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REFERENCES
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- Guirguis, R., Schiffmann, E., Liu, B., Birkbeck, D., Engel, J., Liotta, L .: Detection of 7. autocrine motility factor in urine as a marker of bladder cancer. J. Natl. Cancer Inst., 80: 1203, 1988.
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§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.