Access PCT, Access PCT Calibrators
FDA 510(k) clearance K192271 · decided 2019-11-26
Clearance details
- K-number
- K192271
- Device name
- Access PCT, Access PCT Calibrators
- Applicant
- Beckman Coulter, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-08-22
- Decision date
- 2019-11-26
- Days to decision
- 96 days
- Clearance type
- Traditional
- Product code
- PTF
- Device class
- 2
- Regulation number
- 866.3215
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Chaska, MN, 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 |
|---|---|---|
| DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls (K242294) | Diasys Diagnostic Systems GmbH | 2025-05-09 |
| Access PCT (K222996) | Beckman Coulter, Inc. | 2023-04-26 |
| Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set (K162297) | Diazyme Laboratories | 2017-04-18 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immun recall (Z-1112-2025) | Beckman Coulter Inc. | 2025-02-05 |
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 |