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.

Device Description

The BTA TRAK test for bladder tumor associated antigen is an enzyme immunoassay utilizing monoclonal antibodies to specifically detect the presence of bladder tumor associated antigen in urine.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Bard BTA TRAK™ Test, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state pre-defined "acceptance criteria" in terms of specific performance thresholds that the device had to meet to be considered effective. Instead, it presents the device's sensitivity results (performance data) and claims substantial equivalence to predicate devices. The implicit acceptance criteria are that the device demonstrates comparable or acceptable sensitivity for detecting bladder cancer, stratified by stage and grade, and acceptable specificity across various disease states.

Here's the reported performance:

BTA TRAK 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

Specificity Results of the Bard BTA TRAK test by Disease State (Mean - U/mL)

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

2. Sample Size Used for the Test Set and Data Provenance

Sensitivity Test Set:
- Sample Size: 220 patients with biopsy-proven bladder tumors.
- Data Provenance: Samples were "collected from diverse geographic locations" and stored frozen until tested. It does not explicitly state if it was retrospective or prospective, but the description of biopsy-proven cases and prior collection suggests a retrospective or a pre-collected cohort analysis.
Specificity Test Set:
- Sample Size:
  - Healthy Subjects: 212
  - Non-Genitourinary Benign Diseases: 52
  - Various Genitourinary Diseases: 26 (BPH), 32 (Benign Renal), 94 (Misc. GU), 30 (UTI/Cystitis), 24 (STD), 40 (Other)
  - Genitourinary Trauma: 54
  - Various Genitourinary Cancers (excluding active bladder cancer): 45 (Prostate), 7 (Renal), 25 (Other)
  - No Evidence of Disease (history of bladder cancer): 107
- Data Provenance: Not explicitly stated, but similar to the sensitivity set, the nature of disease states suggests collected samples rather than a real-time prospective study for this broad specificity analysis.

3. Number of Experts and Qualifications for Ground Truth

The summary states that the sensitivity results were determined using "biopsy proven bladder tumors." This implies that the ground truth for bladder cancer presence and its stage/grade was established through histopathological examination by medical professionals (pathologists). The number of pathologists or their specific qualifications (e.g., years of experience) are not provided.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing the ground truth. The sole mention of "biopsy proven" suggests that a single, definitive pathological diagnosis was considered sufficient for ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. This study focuses on the standalone performance of the BTA TRAK test as an aid in management, rather than evaluating its impact on human reader performance with or without AI assistance.

6. Standalone Performance

Yes, a standalone (algorithm only) performance study was performed. The data presented in the tables (Sensitivity and Specificity) represent the direct output and performance of the BTA TRAK test itself, without human intervention in interpreting the test result as part of a diagnostic pathway. The intended use as an "aid in management... in conjunction with cystoscopy" highlights its role as a standalone diagnostic tool whose results are then considered by clinicians.

7. Type of Ground Truth Used

The primary ground truth for the presence and characteristics of bladder cancer was pathology (specifically, "biopsy proven bladder tumors" and "biopsy" for those with no evidence of disease if applicable). For other conditions mentioned in the specificity section (e.g., BPH, UTI, other cancers), the ground truth would likely be based on standard clinical diagnosis, imaging, and/or other laboratory tests.

8. Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This type of regulatory submission (510(k)) for an in vitro diagnostic device often focuses on verification and validation data from a pre-defined test set, rather than detailing the development (training) phase of the assay. For an immunoassay, the "training" would involve assay development and optimization rather than machine learning model training.

9. How the Ground Truth for the Training Set Was Established

Since no training set details are provided, the method for establishing its ground truth is also not mentioned.

Summary

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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 (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

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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

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.