BARD BTA TRAK TEST

K971402 · Bard Diagnostic Sciences,Inc. · MMW · Apr 15, 1998 · Immunology

Device Facts

• Record ID: K971402
• Device Name: BARD BTA TRAK TEST
• Applicant: Bard Diagnostic Sciences,Inc.
• Product Code: MMW · Immunology
• Decision Date: Apr 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Intended 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.

Device Story

BTA TRAK test is an enzyme immunoassay (EIA) for quantitative detection of bladder tumor associated antigen in human urine. Device utilizes monoclonal antibody pair to detect antigen. Performed in microtiter plate format. Used in clinical laboratory settings to assist physicians in managing bladder cancer patients; results used in conjunction with cystoscopy. Provides quantitative antigen levels to aid clinical decision-making regarding patient monitoring and disease management.

Clinical Evidence

Clinical study evaluated 220 patients with biopsy-proven bladder tumors (mean age 68, 79% male). Overall sensitivity was 72%. Sensitivity by stage: Ta (59%), T1 (92%), ≥T2 (88%), Tis (67%). Sensitivity by grade: Grade 1 (53%), Grade 2 (68%), Grade 3 (72%). Specificity data provided across various disease states including healthy subjects, benign GU diseases, and other cancers.

Technological Characteristics

Enzyme immunoassay (EIA) in microtiter plate format. Uses monoclonal antibody pair for antigen detection. In vitro diagnostic assay.

Indications for Use

Indicated for quantitative detection of bladder tumor associated antigen in human urine. Intended as an aid in management of patients diagnosed with bladder cancer in conjunction with cystoscopy.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Bard® BTA® Test (P940018)
• Bard® BTA stat™ Test (K964151)

Submission Summary (Full Text)

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# 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 [phone] [phone] 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)<br>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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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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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

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### 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