Sysmex Xe-5000
510(k) K071967
Sysmex Xe-5000 is a Class II device made by Sysmex America, Inc., cleared under FDA 510(k) K071967 on 20 Nov 2007, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK071967 | Date20 Nov 2007 | StatusActive |
Official records
- FDA 510(k) database K071967
Recalls
-
- Terminated Z-0255-2013
There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the XE-Series because of a low bias.
Timeline
- Cleared FDA 510(k) K071967
- Recall initiated FDA recalls Z-0255-2013
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GKZ
- Device class
- Class II
- Regulation
- 21 CFR Part 864.5220
- Advisory committee
- Hematology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code GKZ (Counter, Differential Cell).
- Pentra 80 by Abx Diagnostics
- MONOCLONAL ANTIBODY IGG2A ISOTYPE CONT. FLOW CYTOM by Gen Trak, Inc.
- Context Filter by Geometric Data, Div. Smithkline Corp.
- Cell-Dyn Emerald 22 System by Abbott Laboratories
- Exact One Hematology Analyzer by Exact Science, Inc.
- SYSMEX E-2500 Automated Hematology System by Toa Medical Electronics USA, Inc.
- Volumet CD4+ and CD8+ T Lymphocyte Count Test Kit by Buckman Co., Inc.
- DXH 300 Coulter Cellular Analysis System, DXH 300C Coulter Cellular Analysis System Model: 71772, 71771 by Beckman Coulter Cellular
- BD Tritest CD3/CD4/CD45 With BD Trucount Absolute Count Tubes, Model 340402 by Bd Biosciences
- Advia 2120 With Autoslide System and Advia 2120I by Siemens Healthcare Diagnostics