Seditainer Erythrocyte Sedimentation Rate (ESR) System
by Becton Dickinson Vacutainer Systems 510(k)
Active
510(k) K953994
Overview
The Seditainer Erythrocyte Sedimentation Rate (ESR) System is a diagnostic device classified as a Tubes, Vials, Systems, Serum Separators, Blood Collection Medical Device. It is designed to measure ESR, a clinical marker used to assess inflammation, infection, or other systemic conditions by quantifying the rate at which red blood cells settle in anticoagulated whole blood over time. The system eliminates the need for manual sedimentation pipettes, streamlining the measurement process in laboratory settings. Its evacuated glass tube configuration ensures precise and reproducible results, critical for accurate patient monitoring.
The system is supplied as a single-use, evacuated glass tube intended for in vitro diagnostic use in clinical chemistry laboratories. It requires no additional preparation beyond standard blood collection procedures, where whole blood is drawn directly into the tube. The device is not intended for MRI environments and must be handled according to standard blood collection and handling protocols. Storage follows typical laboratory guidelines for evacuated blood collection tubes, and its regulatory clearance (FDA 510(k) K953994) confirms compliance with U.S. medical device standards for ESR measurement systems.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK953994 | Date26 Sep 1995 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- JKA
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1675
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Becton Dickinson Vacutainer Systems
Questions
What is the Seditainer ESR System used for?
The Seditainer ESR System is designed to measure erythrocyte sedimentation rate (ESR), a clinical marker used to evaluate inflammation, infection, or systemic conditions. By quantifying how quickly red blood cells settle in anticoagulated whole blood, it provides objective data for patient monitoring and diagnostic assessment in clinical chemistry laboratories.
How is the Seditainer ESR System supplied and prepared for use?
The system is supplied as a single-use, evacuated glass tube. No additional preparation is required beyond standard blood collection procedures—whole blood is drawn directly into the tube, ensuring ease of use while maintaining precision for ESR measurement.
Is the Seditainer ESR System reusable or intended for single-use?
The Seditainer ESR System is explicitly designed for single-use only. This design choice ensures sterility, accuracy, and compliance with laboratory best practices for in vitro diagnostic testing, reducing the risk of contamination or cross-sample error.
What storage guidelines apply to the Seditainer ESR System?
Storage follows standard laboratory protocols for evacuated blood collection tubes. The tubes should be kept in a clean, dry environment, protected from direct sunlight and extreme temperatures, to preserve their integrity and ensure reliable ESR measurement when used.
Can the Seditainer ESR System be used in MRI environments?
No, the Seditainer ESR System is not intended for use in MRI environments. This restriction is due to the presence of glass components and standard blood collection materials, which may pose risks or interfere with MRI compatibility requirements.