The BTA stat test is indicated for use as an aid in the management of bladder cancer patients in conjunction with cystoscopy. This 510(k) is to expand the same indication to prescription home use of the product. The original 510(k) was K964151.

Device Description

The BTA stat test for bladder tumor associated antigen is an immunochromatographic assay utilizing monoclonal antibodies to specifically detect the presence of bladder tumor associated antigen in urine. Patient urine is added to the sample well and allowed to react with a colloidal gold-conjugated antibody. If the antigen is present in the sample, an antigen conjugate complex is formed and a line in the patient (P) test zone appears.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the BTA stat Test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated as Study Objective)	Reported Device Performance (Study Results)
Lay users could read instructions and perform test acceptably well compared to laboratorians (Study 1).	No significant differences in accuracy and repeatability of BTA stat test results were observed between laboratorians and professional lay-persons at three sites.
Persons with a previous diagnosis of bladder cancer could perform the test accurately and comprehend "Instructions for Home Use" (Study 2).	The intended home user population can perform the test at the same level of accuracy observed in laboratory professionals in the first study, and the labeling is easily understood by bladder cancer patients.

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

Study 1 (Comparison of Lay-persons vs. Laboratorians): Not explicitly stated, but implies multiple sites and "professional lay-persons."
Study 2 (Home User Performance): Not explicitly stated, but refers to "persons with a previous diagnosis of bladder cancer" and "bladder cancer patients."
Data Provenance: Not explicitly stated, but the submission is for the BTA Stat Test which is manufactured by Bion Diagnostic Sciences, Inc. in Redmond, WA. The studies were likely conducted in the US. The studies are prospective in nature, as they evaluate user performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The concept of "ground truth" as it relates to expert consensus on clinical findings (like interpreting medical images) is not directly applicable here. This device detects a "bladder tumor associated antigen" in urine. The studies are evaluating the user's ability to perform and interpret the test correctly, rather than the test's diagnostic accuracy against a clinical ground truth.

For Study 1, "laboratorians" would be considered the expert standard for performing the test. Their qualifications are not explicitly stated, but it's implied they are trained laboratory professionals.

For Study 2, the ground truth relates to the correct performance and interpretation of the immunoassay by the home user.

4. Adjudication Method for the Test Set

Not applicable in the traditional sense. The studies focused on whether users could correctly perform and read the test, implying a comparison against an objective result (e.g., presence or absence of a line on the test strip) or against results obtained by trained laboratorians. There's no mention of a
multi-expert adjudication process for the test results themselves.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable. The BTA stat Test is an immunoassay, not an AI-powered diagnostic device requiring human interpretation in the context of images. The studies evaluate user performance with the device itself, not human performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The BTA stat Test is an immunoassay designed to be used by humans (either laboratorians or home users), who then interpret the visible result (a line on the test strip). There is no "algorithm only" component.

7. The Type of Ground Truth Used

As mentioned in point 3, the "ground truth" in these studies is the correct performance and interpretation of the BTA stat immunoassay.

For Study 1, the ground truth for test performance was likely established by the "accuracy and repeatability" achieved by trained laboratorians.
For Study 2, the ground truth for test performance and interpretation was established by comparing home user results to what the test should objectively show, likely based on known samples or comparison to laboratorian results from Study 1. The study also assessed comprehension of the "Instructions for Home Use," where correct comprehension would be the ground truth.

8. The Sample Size for the Training Set

The provided text does not mention a "training set" in the context of machine learning. The studies described are performance studies for the device and user's ability to operate it.

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

Not applicable, as there is no mention of a training set for machine learning.

Summary

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K974845

8 1998 DEC

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:

Bion Diagnostic Sciences, Inc. 12277 134th Court NE, Redmond WA 98052 Alicia Moffat (425)814-1502 (425)814-1520 September 11, 1998

B. Device Name:
Trade Name: Common/Usual Name: Classification Name:

BTA stat Test BTA stat Test Tumor Associated Antigen Immunological Test System

C. Predicate Device Name:

Trade Name:

BTA stat Test K964151

Bion Diagnostic Sciences claims substantial equivalence to the above mentioned test. The new 510(k) is for the addition of an indication for prescription home use.

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510(k) SUMMARY INFORMATION BTA stat Test Page 2

D Device Description:

ಿ Intended Use:

The BTA stat test is an in vitro diagnostic immunoassay indicated for the qualitative detection of bladder tumor associated antigen in urine of persons diagnosed with bladder cancer.

F Indications for Use:

The BTA stat test is indicated for prescription home use as an aid in the management of bladder cancer patients in conjunction with cystoscopy.

(i Substantial Equivalence and Technological Characteristics Summary:

The BTA stat test is a lateral flow assay which detects bladder tumor associated antigen using antigen-specific antibodies. This 510(k) is only for the expanded indication of prescription home use; there are no product changes. Two studies were conducted to demonstrate that lay users could read the test instructions and perform the test acceptably well compared to laboratorians. In the first study, the accuracy and repeatability of BTA stat test results generated by laboratorians and professional lay-persons at three sites were compared and no significant differences in these test performance characteristics were observed between the groups. The second study evaluated the accuracy demonstrated by persons with a previous diagnosis of bladder cancer in performance of the BTA stat test and tested the subjects's ability to comprehend the information in the new "Instructions for Home Use" product labeling. The results indicated that the intended home user population can perform the test at the same level of accuracy observed in laboratory professionals in the first study and that the labeling is easily understood by bladder cancer patients. Several labeling changes were prompted by this study, also.

In conclusion, the BTA stat test when used by lay persons is substantially equivalent to the predicate device referenced in this submission (the same test) when used by laboratory professionals.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with outstretched wings, rendered in black. The bird is positioned to the right of the text, which is arranged in a circular fashion around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

8 1998 DEC

Ms. Alicia Moffat Regulatory affairs Manager Bion Diagnostic Sciences, Inc. 12277 134th Ct. N.E. Redmond, Washington 98052

Re : K974845

Trade Name: BTA stat® Test Regulatory Class: II Product Code: MMW Dated: December 17, 1997 Received: December 18, 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 legally marketed predicate 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug 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 Register. 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.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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Page 2

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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Indications for Use:

Peter E. Maksimi
(Division Sign-Off)

linical Laboratory Dev

(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)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Prescription Home Use _ レ

(Optional Format 1/2/96)

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.