Bard BTA Test
by Bard Diagnostic Sciences, Inc.
510(k) K964151
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK964151 | Date16 Apr 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Bard and Bta Test
- 510(k) Number
- FDA Product Code
- MMW
- FDA applicant
- Bard Diagnostic Sciences,Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.6010
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is a Tumor Marker Monitoring Test System for Bladder Cancer, classified under the nomenclature for immunological tumor-associated antigen assays (21 CFR 866.6010). It detects bladder tumor antigen (BTA) in urine samples to aid in the monitoring of bladder tumor recurrence, supporting diagnostic follow-up in high-risk patients.
The test is supplied as a diagnostic kit for in vitro use, requiring urine samples collected from patients with suspected or confirmed bladder cancer. It is intended for single-use and must be handled under aseptic conditions; no sterility claims are made. The system is classified as Class II under FDA regulations and carries an FDA 510(k) clearance (K964151). Storage and handling follow standard laboratory protocols for immunological assays, with no MRI compatibility or reusable components specified.
Other devices from Bard Diagnostic Sciences, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the BARD AND BTA TEST used for in clinical practice?
The BARD AND BTA TEST is designed to detect bladder tumor antigen (BTA) in urine samples, helping clinicians monitor for bladder tumor recurrence in high-risk patients. It serves as a supportive tool during diagnostic follow-up, particularly for those with suspected or confirmed bladder cancer, by providing additional data for assessment alongside other clinical evaluations.
Is the BARD AND BTA TEST intended for single-use or repeated use?
The BARD AND BTA TEST is explicitly intended for single-use only. Each kit is meant to be used once and must be handled under aseptic conditions, as reuse is not supported or recommended by the manufacturer.
How should the BARD AND BTA TEST be stored, and are there any special handling requirements?
The BARD AND BTA TEST follows standard laboratory protocols for storage and handling, typical of immunological assays. While no specific storage conditions (like temperature or humidity) are detailed in the data, it is critical to adhere to general laboratory practices for in vitro diagnostic tests to maintain accuracy and reliability. The test does not claim sterility, so aseptic handling is required during use.
What type of regulatory clearance does the BARD AND BTA TEST hold, and how was it determined?
The BARD AND BTA TEST holds an FDA 510(k) clearance (K964151) and is classified as a Class II device under FDA regulations. The clearance was granted through a traditional review process by the Immunology (IM) Advisory Committee, with the device deemed substantially equivalent to a predicate under the nomenclature for immunological tumor-associated antigen assays (21 CFR 866.6010).
What kind of urine samples can be used with the BARD AND BTA TEST, and are there any special considerations?
The BARD AND BTA TEST is designed for use with urine samples collected from patients with suspected or confirmed bladder cancer. While the test does not specify collection protocols beyond standard urine sampling, it is important to ensure the sample is representative and handled according to typical laboratory practices for immunological assays to avoid contamination or degradation of the BTA marker.