Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a lateral flow immunoassay, which relies on chemical reactions and visual interpretation, not computational analysis. The summary explicitly states "Not Found" for mentions of AI, DNN, or ML, and describes a purely biological and chemical detection method.

Therapeutic

No
The device is an in vitro diagnostic immunoassay that measures biomarkers to aid in the management of bladder cancer. It provides diagnostic information but does not treat or cure a disease.

Diagnostic

Yes

The device is an immunoassay designed for the in vitro qualitative measurement of fibrinogen and fibrinogen degradation products in human urine. It is used to aid in the management of patients with a history of bladder cancer, which directly supports diagnosis or management of a disease state.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical immunoassay kit (lateral flow immunoassay on a porous carrier with gold dye particles and antibodies) and does not mention any software component.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is indicated for the "in vitro qualitative measurement of fibringen and fibrinogen degradation products (FDP) in human urine". The term "in vitro" means "in glass" or "in the laboratory," referring to tests performed outside of the living body.
Sample Type: The device analyzes "human urine," which is a biological specimen taken from the body.
Purpose: The test is used to "aid in the management of patients with a history of bladder cancer," indicating a diagnostic or monitoring purpose related to a medical condition.
Device Description: The description details a "lateral flow immunoassay," which is a common type of in vitro diagnostic test.

All of these points align with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

82 MMW

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Bladder

Indicated Patient Age Range

Not Found

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

Not Found

Summary of Performance Studies

Analytical Sensitivity / Limits of Detection: 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.
Reproducibility: Qualitative reproducibility studies were conducted to determine within-day, between laboratory and between-lot variability.
- Within-day reproducibility: Tested using a negative control sample (0 ng FE/mL), a low level control (25 ng FE/ml), and a high level control (250 ng FE/mL). All controls were tested using twenty replicates at each level.
- Other studies: 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.
- Key Result: All reproducibility studies demonstrated total qualitative agreement at each control level.
High Dose Hook (Prozone) Effect: AuraTek FDP was tested using high concentration FDP specimens to assess high dose hook effects in patient samples with high concentrations of analyte.
- Key Result: No hook effects were seen at concentrations up to 2000 ng FE/ml.
Interfering Substances: AuraTek FDP was performed with urine specimens containing a variety of potentially interfering substances including hemoglobin, albumin, bilirubin unconjugated, uric acid, various drugs, blood cells, whole blood, plasma, serum, and IgG antibody.
- Key Result: Whole blood and plasma may cause positive interference with AuraTek FDP at levels greater than 0.0156% volume/volume.
Clinical Sensitivity: 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 Subcontinent subject and 5 subjects of unknown racial origin. Bladder tumors were confirmed in 79 patients by positive cystoscopy results with confirmatory biopsy.
- All Stages (n=79): AuraTek FDP Positive 68% (54/79), 95% CI 56.9-78.4%. Cytology Positive 34% (27/79), 95% CI 23.9-45.7%. Hemoglobin Dipstick 41% (32/79), 95% CI 33.6-54.8%.
- Superficial (Tis, Ta, T1) (n=67): AuraTek FDP Positive 63% (42/67), 95% CI 50.0-74.2%.
- Invasive (T2, T3, T4) (n=12): AuraTek FDP Positive 100% (12/12), 95% CI 73.5-100%.
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.
- Healthy subjects (n=73): AuraTek FDP Negative 96% (70/73), 95% CI 88.5-99.1%.
- Cystoscopy negative patients with a history of bladder cancer (n=113): AuraTek FDP Negative 80% (90/113), 95% CI 72.2-87.1%.
- All Urological Disease (n=232): Specificity 86.2%, 95% CI (81.1-90.4).

Key Metrics

Sensitivity (Clinical Study):
- All Stages: 68% (54/79), 95% Confidence Interval 56.9-78.4%
- Superficial (Tis, Ta, T1): 63% (42/67), 95% Confidence Interval 50.0-74.2%
- Invasive (T2,T3,T4): 100% (12/12), 95% Confidence Interval 73.5-100%
- Tis: 67% (4/6), 95% Confidence Interval 22.3-95.7%
- Ta: 62% (28/45), 95% Confidence Interval 46.5-76.2%
- T1: 63% (10/16), 95% Confidence Interval 35.4-84.8%
- G1: 62% (8/13), 95% Confidence Interval 31.6-86.1%
- G2: 64% (23/36), 95% Confidence Interval 46.2-79.2%
- G3, G4: 86% (19/22), 95% Confidence Interval 65.1-97.1%
- Not Assigned: 50% (4/8), 95% Confidence Interval 15.7-84.3%
Specificity:
- Healthy subjects: 96% (70/73), 95% Confidence Interval 88.5-99.1%
- Cystoscopy negative patients with a history of bladder cancer: 80% (90/113), 95% Confidence Interval 72.2-87.1%
- All Urological Disease: 86.2%, 95% Confidence Interval (81.1-90.4)
- Total Prostate Disease: 89.1%, 95% Confidence Interval (81.4-94.4)
- Total Renal Disease: 76.9%, 95% Confidence Interval (56.4-91.0)
- Urinary Tract Infections: 76.9%, 95% Confidence Interval (46.2-95.0)
- Total Bladder Disease: 84.4%, 95% Confidence Interval (67.2-94.7)
- Total Urodynamic Disease: 92.9%, 95% Confidence Interval (76.5-99.1)
- Total Testicular Disease: 100%, 95% Confidence Interval (63.1-100.0)
- Total Urological Cancers: 85.7%, 95% Confidence Interval (73.8-93.6)
Limit of Detection: Approximately 30 ng Fibrinogen Equivalents (FE) / ml

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

K970353

Property of Concession Comments of Children Comments of Children

(

000009

APR 30 1997

AuraTek FDP 510(k) #K970353

510(k) SUMMARY

机制

1

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 58
2300 Turnhout, Belgium
Authorized representative in the U.S.:	PerImmune, Inc.
1330 Piccard Drive
Rockville, MD 20850-4396
Tel: (301) 258-5200
Contact: 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.

ﺴﯧﺮﯦ

000010

2

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.

3

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

4

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)

5

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 lateral
flow immunoassay indicated
for the [ in vitro qualitative
measurement] of fibrinogen
and fibrin/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.]	The Bard BTA rapid latex
agglutination test is an [ in vitro ]
device intended for the
[qualitative] measurement of
Bladder Tumor Associated
Analytes in human urine [to aid in
the management of bladder cancer
patients.]
Sample Matrix	Urine	Urine
Format	Rapid lateral flow
immunoassay	Rapid latex agglutination test
Analyte	Fibrinogen and
Fibrin/Fibronogen Degradation
Products (FDP)	Bladder Tumor Associated
Analytes
Limit of Detection	30 ng Fibrinogen Equivalents
(FE) / ml	$9.8 \mu g/ml$ Bladder Tumor
Associated 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.

6

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.

7

| Substance Interference (1) |
|------------------------|-------- | Hemoglobin | 225 mg/dl | Albumin | 10 g/l | Bilirubin unconjugated | 206 mg/dl | Uric Acid | 250 mg/dl | Disodium cromoglycate | 10 mg/l | Cetirizine HCl | 10 mg/l | Caffeine | 100 mg/l | Paracetamol | 500 mg/l | Ibuprofen | 400 mg/l | Acetylsalicylic Acid | 500 mg/l | Amoxicillin | 200 mg/l | Oxazepam | 25 mg/l | Diazepam | 20 mg/l | Ethanol | 2000 mg/l | Desogestrel | 5 mg/l | Prednisone | 10 mg/l | Clomiphene Citrate | 50 mg/l | Ethinylestradiol | 5 mg/l | Heroin | 6 mg/l | Morphine | 6 mg/l | Tetrahydrcannabinol | 6 mg/l | Sodium Chloride | 100 mg/l | Amphetamine Sulfate | 10 mg/l | Chlorpromazine | 50 mg/l | Ascorbic Acid | 30 mg/l | Nicotine | 20 mg/l | Domperidone | 20 mg/l | Doxycycline | 200 mg/l | Methadone | 6 mg/l | Glucose | 10 g/l | Red blood cells | 1 X 10⁶ / ml | White blood cells | 5 X 10⁴ / ml | Whole blood | 1% vol/vol | Plasma | 1% vol/vol | Serum | 1% vol/vol | IgG Antibody | 6.25 mg/dl | Highest Concentration Tested | Highest Concentration with no
----------------------|---------------------------------------------------|
| 225 mg/dl |
| 10 g/l |
| 206 mg/dl |
| 250 mg/dl |
| 10 mg/l |
| 10 mg/l |
| 100 mg/l |
| 500 mg/l |
| 400 mg/l |
| 500 mg/l |
| 200 mg/l |
| 25 mg/l |
| 20 mg/l |
| 2000 mg/l |
| 5 mg/l |
| 10 mg/l |
| 50 mg/l |
| 5 mg/l |
| 6 mg/l |
| 6 mg/l |
| 6 mg/l |
| 100 mg/l |
| 10 mg/l |
| 50 mg/l |
| 30 mg/l |
| 20 mg/l |
| 20 mg/l |
| 200 mg/l |
| 6 mg/l |
| 10 g/l |
| 1 X 10⁶ / ml |
| 5 X 10⁴ / ml |
| 0.0156% vol/vol (2) |
| 0.0156% vol/vol (2) |
| 1% vol/vol |
| 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.

8

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
Disease
Stage	Number of
Subjects	AuraTek
FDP
Positive	AuraTek
FDP 95%
Confidence
Interval	Cytology
Positive	Cytology
95%
Confidence
Interval	Hemo-
globin
Dipstick	Hemo-
globin
Dipstick
95%
Confidence
Interval
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%

9

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

10

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
Disease
Grade	Number of
Subjects	AuraTek
FDP
Positive	AuraTek
FDP 95%
Confidence
Interval	Cytology
Positive	Cytology
95% Confidence
Interval	Hemo-
globin
Dipstick	Hemo-
globin
Dipstick
95% Confidence
Interval
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%
Not
Assigned	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 of
Subjects	AuraTek FDP
Negative	AuraTek FDP
95% Confidence
Interval
Healthy subjects	n=73	96%
(70/73)	88.5-99.1%
Cystoscopy negative
patients with a history of
bladder 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 Cancer

Urological Disease
Disease
Category	Disease	Total
Evaluable
Subjects	AuraTek
FDP
Negative	Specificity	95%
Confidence
Interval
Total	All Urological
Disease	232	200	86.2	(81.1-90.4)
Prostate	Benign prostatic
hypertrophy	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 Prostate
Disease	101	90	89.1	(81.4-94.4)
Renal	Renal stones	12	10	83.3	(51.6-97.9)
	Renal cell
carcinoma	10	9	90.0	(55.8-99.7)
	Transitional cell
carcinoma	1	0	0	NA
	Misc. renal	3	1	33.3	(0.8-90.6)
	Total Renal
Disease	26	20	76.9	(56.4-91.0)
Urinary Tract
Infections	Urinary tract
infections	13	10	76.9	(46.2-95.0)
Bladder	Interstitial
cystitis	27	24	88.9	(70.8-97.7)
	Misc. bladder
disease	5	3	60.0	(14.7-94.3)
	Total Bladder
Disease	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)
	Total
Urodynamic
Disease	28	26	92.9	(76.5-99.1)
Testes	Testicular
cancer	5	5	100	(47.8-100.0)
	Misc. testicular	5	5	100	(47.8-100.0)
	TotalTesticular
Disease	10	10	100	(63.1-100.0)
Miscellaneous	Misc. categories	22	17	77.3	(54.6-92.2)
Cancer*	Total Urological
Cancers	56	48	85.7	(73.8-93.6)

Includes subjects from all disease categories

13

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Parry, W.L., Hemstreet, G.P .: Cancer detection by quantitative fluorescence image 3. analysis. J. Urol., 139(2): 270, 1988
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Wajsman, Z., Merrin, C.E., Chu, T.M., Moore, R.H., Murphy, G.P.: Evaluation of ರು. biological markers in bladder cancer. J. Urol., 114: 879, 1975.
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Marder, V.J., Budzynski, A.Z.: The structure of the fibrinogen degradation products. In: 12. Progress in Hemostasis and Thrombosis. Edited by T. H. Spaet. New York: Grune & Stratton, vol. 2, pp 141-174, 1974.

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