iQ200 System, iChemVELOCITY Automated Urine Chemistry System
FDA 510(k) clearance K210127 · decided 2021-07-02
Clearance details
- K-number
- K210127
- Device name
- iQ200 System, iChemVELOCITY Automated Urine Chemistry System
- Applicant
- Beckman Coulter, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-01-19
- Decision date
- 2021-07-02
- Days to decision
- 164 days
- Clearance type
- Traditional
- Product code
- LKM
- Device class
- 2
- Regulation number
- 864.5200
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| iQ200 Series (K252580) | Beckman Coulter, Inc. | 2025-09-10 |
| AUTION EYE AI-4510 Urine Particle Analysis System (K232416) | Arkray, Inc. | 2024-05-03 |
| cobas u 701 microscopy analyzer (K200811) | Roche Diagnostics | 2020-11-06 |
| Sysmex UF-5000 Fully Automated Urine Particle Analyzer (K171883) | Sysmex America, Inc. | 2018-04-23 |
| IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE (K093861) | Iris International, Inc. | 2010-02-05 |
| SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER (K083002) | Sysmex America, Inc. | 2009-02-03 |
| SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE (K080887) | Sysmex America, Inc. | 2008-05-02 |
| SYSMEX MODEL UF1000I (K070910) | Sysmex America, Inc. | 2007-05-25 |
| SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER (K053135) | Sysmex America, Inc. | 2006-01-04 |
| IQ 200 SYSTEM (K022774) | Intl. Remote Imaging Systems | 2002-10-21 |
| SYSMEX UF-50 (K012372) | Sysmex Corp. | 2001-09-28 |
| 939UDX URINE PATHOLOGY SYSTEM (K000373) | Intl. Remote Imaging Systems | 2000-04-14 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345 recall (Z-1596-2023) | Beckman Coulter, Inc. | 2023-05-17 |
| DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, recall (Z-1597-2023) | Beckman Coulter, Inc. | 2023-05-17 |
| DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device recall (Z-1598-2023) | Beckman Coulter, Inc. | 2023-05-17 |
| UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis recall (Z-1599-2023) | Beckman Coulter, Inc. | 2023-05-17 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Access AFP (on DxI 9000 Analyzer) (P980041/S051) | Beckman Coulter, Inc. | 2025-11-03 |
| Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC (P230015) | Beckman Coulter, Inc. | 2025-10-17 |
| Access Hybritech p2PSA (P090026/S032) | Beckman Coulter, Inc. | 2025-06-16 |
| Access Hybritech free PSA (P970038/S046) | Beckman Coulter, Inc. | 2025-05-15 |
| Access Hybritech PSA (P850048/S060) | Beckman Coulter, Inc. | 2024-09-04 |
| Access Hybritech PSA reagent pack (P850048/S059) | Beckman Coulter, Inc. | 2023-05-25 |
| Access AFP Reagents on the Access Immunoassay Systems (P980041/S050) | Beckman Coulter, Inc. | 2022-12-16 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S057) | Beckman Coulter, Inc. | 2022-12-16 |