Crp-Lex System: C-Reactive Protein Antigen Detection in Serum: Slide Agglutnation Latex Test
510(k) K972160
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK972160 | Date1 Aug 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DCK
- 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 CRP-Lex System is a slide agglutination latex test designed for the qualitative detection of C-reactive protein (CRP) antigen in human serum. It functions by utilizing latex particles that agglutinate when CRP is present at concentrations of 8 µg/mL (0.8 mg/dL) or higher, enabling rapid visual identification of elevated CRP levels. This device falls under the category of in vitro diagnostic reagents and is classified as a Class II medical device under FDA regulations.
The CRP-Lex System is intended for use in hospital and clinical laboratories by trained personnel. It is supplied as a single-use diagnostic kit and does not require sterilization beyond its sterile packaging. The device is not MRI-compatible, and no specific storage conditions beyond standard laboratory practices are noted. It has received FDA 510(k) clearance under the Traditional pathway, with the advisory committee classification under Immunology. The product code assigned is DCK, and it is regulated under FDA regulation number 866.5270.
Other devices from Trinity Laboratories, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the CRP-Lex System used for?
The CRP-Lex System is designed for the qualitative detection of C-reactive protein (CRP) antigen in human serum. It identifies elevated CRP levels (≥8 µg/mL or 0.8 mg/dL) through a slide agglutination latex test, enabling rapid visual assessment of inflammation or infection markers in clinical settings.
How is the CRP-Lex System supplied and prepared for use?
The CRP-Lex System is supplied as a single-use diagnostic kit. Each kit contains all necessary components for one test, eliminating the need for additional sterilization beyond the sterile packaging provided. It is intended for use by trained personnel in hospital or clinical laboratories, where standard laboratory practices ensure proper handling and testing.
Is the CRP-Lex System reusable or single-use?
The CRP-Lex System is explicitly designed for single-use only. This ensures patient safety and test accuracy, as reuse could compromise sterility or reliability. Each kit is packaged sterile and intended for one-time use per the manufacturer’s instructions.
What storage conditions are required for the CRP-Lex System?
The CRP-Lex System does not specify unique storage conditions beyond standard laboratory practices. It should be stored in a clean, dry environment protected from extreme temperatures, direct sunlight, and physical damage. Adherence to typical in vitro diagnostic reagent storage guidelines is recommended to maintain integrity.
Does the CRP-Lex System require any special handling or compatibility considerations?
The CRP-Lex System is not MRI-compatible, meaning it should not be used or stored in environments where MRI procedures occur. Additionally, it relies on visual agglutination results, so proper lighting and a clean workspace are essential for accurate interpretation. No other special handling is noted beyond standard aseptic techniques for in vitro diagnostics.