BTA STAT Test Prescription Home Use
by Bard Diagnostic Sciences, Inc.
510(k) K974845
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK974845 | Date8 Dec 1998 | 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- Withdrawn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
- 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, 1 Oct 2026
The BTA STAT Test Prescription Home Use is an in vitro diagnostic immunoassay designed for the qualitative detection of bladder tumor-associated antigen (BTA) in urine. Classified as a System, Test, Tumor Marker, Monitoring, Bladder, this device aids in the monitoring of bladder cancer patients by providing a rapid, point-of-care result. It falls under the Immunology specialty and is intended for use in conjunction with clinical assessments, such as cystoscopy, to support patient management.
This device is supplied as a single-use, non-sterile test kit for home prescription use, requiring no special storage conditions beyond those specified in the accompanying instructions. It is regulated under FDA 510(k) clearance (K974845) and falls under Class II medical device classification. The test is intended for use by trained individuals under medical supervision, adhering to the prescribed protocol for urine sample collection and analysis. No MRI safety considerations apply, as it is not a magnetic resonance-compatible device.
Other devices from Bard Diagnostic Sciences, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the BTA STAT Test Prescription Home Use designed for?
The BTA STAT Test Prescription Home Use is an in vitro diagnostic immunoassay intended for the qualitative detection of bladder tumor-associated antigen (BTA) in urine. It supports the monitoring of bladder cancer patients by providing rapid, point-of-care results. This test is meant to be used alongside clinical assessments, such as cystoscopy, to help guide patient management under medical supervision.
How is the BTA STAT Test supplied and stored?
The BTA STAT Test is supplied as a single-use, non-sterile test kit for home prescription use. It does not require special storage conditions beyond those outlined in the provided instructions. Always follow the included guidelines to ensure proper handling and usability.
Is the BTA STAT Test sterile?
No, the BTA STAT Test is classified as non-sterile. It is designed for single-use only, which eliminates the need for sterile packaging or conditions. This aligns with its intended use for home prescription monitoring under medical supervision.
Who can use the BTA STAT Test, and how?
The BTA STAT Test is intended for use by trained individuals under medical supervision. It requires adherence to the prescribed protocol for urine sample collection and analysis. The test is not intended for self-diagnosis or use without proper medical guidance.
Does the BTA STAT Test have any special safety considerations?
The BTA STAT Test does not involve magnetic resonance imaging or MRI-compatible materials, so there are no specific MRI safety considerations. However, it must be used strictly according to the provided instructions to ensure accurate and reliable results.