Cromatest Rheumatoid Diagnostic/Crp Latex Test
by Biotrax, Inc. 510(k)
Active
510(k) K904497
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK904497 | Date1 Nov 1990 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DCN
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5270
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Cromatest Rheumatoid Diagnostic CRP Latex Test is a system, test, C-reactive protein device, classified under FDA regulation 866.5270. It is designed as an immunochemical test system for the qualitative and semiquantitative detection of C-reactive protein (CRP) in serum using a rapid slide agglutination method based on the Singer technique. The test leverages latex particles coated with specific antigens to visually identify CRP through agglutination reactions, aiding in the diagnosis of inflammation or infection.
This device is supplied as a single-use diagnostic kit and is intended for use in clinical laboratory settings by trained personnel. It requires no special storage conditions beyond refrigeration (2–8°C) and is not intended for reuse. The test does not involve MRI compatibility considerations. Authorized under FDA 510(k) clearance K904497 with a Substantially Equivalent (SESE) determination, it falls under Class II regulatory classification. No third-party review was conducted, and the device adheres to immunology specialty standards as per the Immunology (IM) advisory committee.
Other devices from Biotrax, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Cromatest CRP Latex Test used for?
The Cromatest CRP Latex Test is designed for the qualitative and semiquantitative detection of C-reactive protein (CRP) in serum. CRP is a marker for inflammation or infection, so this test helps clinicians diagnose or monitor conditions like rheumatoid arthritis, infections, or other inflammatory diseases. The rapid slide agglutination method provides visual results based on latex particle agglutination.
How is the Cromatest CRP Latex Test supplied and stored?
The Cromatest CRP Latex Test is supplied as a single-use diagnostic kit, meaning each test is intended for one-time use only. It requires refrigeration between 2°C and 8°C for optimal stability and performance. No additional storage conditions are specified beyond this temperature range.
Is the Cromatest CRP Latex Test reusable or sterile?
The Cromatest CRP Latex Test is explicitly designed for single-use only. While the device itself is not labeled as sterile in the provided data, it is intended for use in clinical laboratory settings by trained personnel, where standard aseptic practices would apply. Reuse is not recommended or supported by the manufacturer.
What regulatory approval does the Cromatest CRP Latex Test have?
The Cromatest CRP Latex Test holds FDA 510(k) clearance under the reference number K904497, with a Substantially Equivalent (SESE) determination. This classification places it under FDA regulation 866.5270 and falls under Class II medical devices. The device adheres to immunology specialty standards as reviewed by the Immunology (IM) advisory committee.
Are there different sizes or models of the Cromatest CRP Latex Test?
The provided data does not specify multiple sizes or models for the Cromatest CRP Latex Test. It is described as a single diagnostic kit system for CRP detection, implying a standardized format for clinical use. If variations exist, they are not detailed in the available information.