(365 days)
P940018, K964151
P940018, K964151
No
The device description and performance studies describe a standard enzyme immunoassay for detecting a specific antigen, with no mention of AI or ML techniques.
No
The device is an in vitro diagnostic assay used for detection, not treatment, of disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "The Bard BTA TRAK Test is an in vitro diagnostic assay indicated for the quantitative detection of bladder tumor associated antigen in human urine." It also mentions its use "as an aid in management of bladder cancer patients in conjuction with cystoscopy," directly aligning with the definition of a diagnostic device.
No
The device is an in vitro diagnostic assay that utilizes an enzyme immunoassay, which is a laboratory test involving physical reagents and processes, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Bard BTA TRAK Test is an in vitro diagnostic assay indicated for the quantitative detection of bladder tumor associated antigen in human urine."
This statement directly identifies the device as an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Bard BTA TRAK Test is an in vitro diagnostic assay indicated for the quantitative detection of bladder tumor associated antigen in human urine. This test is intended for use as an aid in management of bladder cancer patients in conjuction with cystoscopy.
Product codes
MMW
Device Description
The BTA TRAK test for bladder tumor associated antigen D. is an enzyme immunoassay utilizing monoclonal antibodies to specifically detect the presence of bladder tumor associated antigen in urine.
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
The BTA TRAK test sensitivity results were determined using urine samples from 220 patients with biopsy proven bladder tumors. Samples were collected from diverse geographic locations and stored frozen until tested. Testing of samples for this study was performed on-site at Bard Diagnostic Sciences, Inc.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data: The BTA TRAK test sensitivity results were determined using urine samples from 220 patients with biopsy proven bladder tumors. Samples were collected from diverse geographic locations and stored frozen until tested. Testing of samples for this study was performed on-site at Bard Diagnostic Sciences, Inc. The average age was 68 years and 79% were males. Results are presented below by stage and by grade of the tumor.
BTA stat Test Sensitivity by Stage and Grade*:
Stage: Ta, N: 108, Sensitivity (%): 59; T1, N: 38, Sensitivity (%): 92; >=T2, N: 50, Sensitivity (%): 88; Tis, N: 18, Sensitivity (%): 67
Grade: 1, N: 53, Sensitivity (%): 53; 2, N: 56, Sensitivity (%): 68; 3, N: 96, Sensitivity (%): 72
Overall, N: 216, Sensitivity (%): 72
- Includes 2 patients without stage and 11 without grade determinations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity:
By Stage: Ta (59%), T1 (92%), >=T2 (88%), Tis (67%)
By Grade: 1 (53%), 2 (68%), 3 (72%)
Overall Sensitivity: 72%
Specificity Results of the Bard BTA TRAK test by Disease State (Mean - U/mL):
Healthy Subjects: 4.1 (N=212)
Non-Genitourinary (GU) Benign Diseases: 2.0 (N=52)
Genitourinary Diseases: BPH (9.0, N=26), Benign Renal Disease (78.7, N=32), Misc. GU Disease (26.3, N=94), UTI/Cystitis (61.8, N=30), STD (11.2, N=24), Other (8.8, N=40), Genitourinary Trauma (1031.9, N=54)
Genitourinary Cancers: Prostate Cancer (64.4, N=45), Renal Cancer (1039.0, N=7), Other Cancers (3.3, N=25)
Active Bladder Cancer A: Grade I (212.4, N=53), Grade II (543.0, N=56), Grade III (913.9, N=96), Stage Tis (68.4, N=18), Stage Ta (316.7, N=108), Stage T1 (851.0, N=38), Stage T2 - T4 (1250.5, N=50)
No Evidence of Disease B: 31.8 (N=107)
Predicate Device(s)
P940018, K964151
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
1971402
APR 1 5 1998
510(k) SUMMARY INFORMATION
This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitter's Information: A.
Submitter's Name: Address: Contact Person: Contact Person's Phone: Contact Person's Fax: Date of Preparation:
- Device Name: B.
Trade Name: Common / Usual Name: Classification Name:
Bard Diagnostic Sciences, Inc. 12277 134th Ct., NE Glen Paul Freiberg (206) 814-1520 (206) 814-1521 April 10, 1997
Bard® BTA TRAK ™ Test BTA TRAK™Test Tumor Associated Antigen Immunological Test System
- C. Predicate Device Name:
Trade Name:
Bard® BTA® Test P940018 - Reclassified to Class II Bard® BTA stat™ Test K964151
Bard Diagnostic Sciences, Inc., claims substantial equivalence to the above mentioned tests.
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- Device Description: The BTA TRAK test for bladder tumor associated antigen D. is an enzyme immunoassay utilizing monoclonal antibodies to specifically detect the presence of bladder tumor associated antigen in urine.
- E. Intended Use:
The BTA stat test is for the quantitative detection of bladder tumor associated antigen in human urine.
-
F. Indications for Use:
The BTA TRAK test is an in vitro diagnostic assay indicated for the quantitative detection of bladder tumor associated antigen in human urine. This test is intended for use as an aid in management of bladder cancer patients in conjuction with cystoscopy. -
G. Substantial Equivalence & Technological Characteristics Summary:
The Bard BTA TRAK test and the Bard BTA stat test both use the same monoclonal antibody pair to detect bladder tumor associated antigen. The BARD BTA TRAK test is an enzyme immunoassay in microtiter plate format. The Bard BTA stat test is a lateral flow assay which detects antigen though antigen-specific antibodies. The Bard BTA Test is a test strip assay which detects "bladder tumor associated analytes" through an agglutination interaction with IgG coated latex particles. All of the assays are intended for management of bladder cancer patients. The first two detect a different substance than the original BARD BTA test.
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510(k) SUMMARY INFORMATION Bard BTA TRAK Test Page 3
Specificity Results of the Bard BTA TRAK test by Disease State
| Category | N | Mean - U/mL |
|---|---|---|
| Healthy Subjects | 212 | 4.1 |
| Male > 50 years | 21 | 2.7 |
| Female > 50 years | 67 | 93 |
| M/F 35 - 50 years | 164 | 4.5 |
| Non-Genitourinary (GU) | ||
| Benign Diseases | 52 | 2.0 |
| Genitourinary Diseases | ||
| BPH | 26 | 9.0 |
| Benign Renal Disease | 32 | 78.7 |
| Misc. GU Disease | 94 | 26.3 |
| UTI/Cystitis | 30 | 61.8 |
| STD | 24 | 11.2 |
| Other | 40 | 8.8 |
| Genitourinary Trauma | 54 | 1031.9 |
| Genitourinary Cancers | ||
| Prostate Cancer | 45 | 64.4 |
| Renal Cancer | 7 | 1039.0 |
| Other Cancers | 25 | 3.3 |
| Active Bladder Cancer A | ||
| Grade I | 53 | 212.4 |
| Grade II | 56 | 543.0 |
| Grade III | 96 | 913.9 |
| Stage Tis | 18 | 68.4 |
| Stage Ta | 108 | 316.7 |
| Stage T1 | 38 | 851.0 |
| Stage T2 - T4 | 50 | 1250.5 |
| No Evidence of Disease B | 107 | 31.8 |
A - Includes 2 patients with grade but unknown stage and 11 with stage but unknown grade
B - History of bladder cancer but no disease evident on follow-up with cystoscopy and/or biopsy.
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H. Performance Data:
The BTA TRAK test sensitivity results were determined using urine samples from 220 patients with biopsy proven bladder tumors. Samples were collected from diverse geographic locations and stored frozen until tested. Testing of samples for this study was performed on-site at Bard Diagnostic Sciences, Inc. The average age was 68 years and 79% were males. Results are presented below by stage and by grade of the tumor.
BTA stat Test Sensitivity by Stage and Grade*
| Stage | N | Sensitivity (%) |
|---|---|---|
| Ta | 108 | 59 |
| T1 | 38 | 92 |
| ≥T2 | 50 | 88 |
| Tis | 18 | 67 |
| Grade | N | Sensitivity (%) |
| 1 | 53 | 53 |
| 2 | 56 | 68 |
| 3 | 96 | 72 |
| Overall | 216 | 72 |
- Includes 2 patients without stage and 11 without grade determinations.
In conclusion, the Bard BTA TRAK Test is substantially equivalent to the predicate devices referenced in this submission.
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Image /page/4/Picture/2 description: The image shows a partial view of a document or logo. On the left side, there's a stylized graphic with thick, wavy lines, possibly representing a design element or abstract symbol. The word "DEPART" is partially visible, rotated and positioned near the graphic. To the right, there's a horizontal line, and below it, a large letter "A" is visible, suggesting the beginning of a word or title.
APR 1 5 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Alicia J. Moffat Requlatory, Regulatory Affairs Specialist Bard Diagnostic Sciences, Inc. 12277 134th Ct. N.E., #100 Redmond, Washington 98052
Re : K971402/S3 Trade Name: Bard® BTA TRAK™ Test Regulatory Class: II Product Code: MMW Dated: February 19, 1998 Received: February 20, 1998
Dear Ms. Moffat:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. 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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General --------requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
SECTION I D INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Bard® BTA TRAK™ Test Device Name:
Indications for Use:
The Bard BTA TRAK Test is indicated for the quantitative detection of bladder tumor associated antigen in urine of persons diagnosed with bladder cancer. This test an aid in the management of bladder cancer patients in conjunction with cystoscopy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
V Prescription Use (Per 21 CFR 801.109)
OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1/2/96)
Titu Q. Madion
(Division Sig Division of Clin 510(k) Num