Dimension PSA Flex Reagent Cartridge
by Dade Behring, Inc. 510(k)
Active
510(k) K003963
Overview
The Dimension PSA Flex Reagent Cartridge is a solid phase, two-site, one-step immunoenzymetric assay reagent cartridge designed for quantitative measurement of prostate-specific antigen (PSA) in serum or plasma. It employs two PSA-specific murine monoclonal antibodies—one as a capture antibody and the other as a tag antibody—to detect and quantify PSA levels, supporting clinical management of prostate cancer.
This cartridge is intended for use exclusively on the Dimension clinical chemistry system with the Heterogeneous Immunoassay Module. Supplied as a single-use, sterile reagent cartridge (LTJ product code), it requires no additional preparation beyond insertion into the system. The device holds FDA 510(k) clearance (K003963) under the Immunology advisory committee classification and is regulated under 21 CFR 866.6010. Storage conditions and shelf life are specified in the accompanying documentation.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK003963 | Date28 Feb 2001 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LTJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.6010
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Dade Behring, Inc.
Questions
What is the Dimension PSA Flex Reagent Cartridge used for?
The Dimension PSA Flex Reagent Cartridge is designed for quantitative measurement of prostate-specific antigen (PSA) levels in serum or plasma samples. PSA testing helps clinicians monitor and manage prostate cancer by providing measurable data on PSA concentrations, aiding in diagnosis, treatment planning, and follow-up care.
How is the Dimension PSA Flex Reagent Cartridge supplied and prepared for use?
The cartridge is supplied as a single-use, sterile reagent cartridge (LTJ product code) and requires no additional preparation beyond insertion into the Dimension clinical chemistry system with its Heterogeneous Immunoassay Module. This ensures ease of use and reduces the risk of contamination or cross-sample exposure.
Is the Dimension PSA Flex Reagent Cartridge reusable or single-use?
The cartridge is explicitly designed for single-use only. This design minimizes the risk of carryover contamination between samples and ensures consistent, reliable results for each test. Single-use cartridges also align with best practices for infection control and patient safety in clinical settings.
What system is required to use the Dimension PSA Flex Reagent Cartridge?
The cartridge is intended for exclusive use on the Dimension clinical chemistry system equipped with the Heterogeneous Immunoassay Module. This compatibility ensures accurate and reproducible immunoenzymetric assay results, as the system is optimized for the cartridge’s specific assay chemistry and workflow.
Where can I find information on storage and shelf life for the Dimension PSA Flex Reagent Cartridge?
Storage conditions and shelf life details are provided in the accompanying documentation included with the cartridge. Proper storage is critical to maintaining assay performance, and the manufacturer’s instructions should be followed to ensure the cartridge remains effective until its expiration date.