Elecsys BRAHMS PCT
FDA 510(k) clearance K192815 · decided 2020-03-09
Clearance details
- K-number
- K192815
- Device name
- Elecsys BRAHMS PCT
- Applicant
- Roche Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2019-10-01
- Decision date
- 2020-03-09
- Days to decision
- 160 days
- Clearance type
- Traditional
- Product code
- PRI
- Device class
- 2
- Regulation number
- 866.3215
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Indianapolis, IN, 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 |
|---|---|---|
| Dimension EXL LOCI BRAHMS Procalcitonin (PCT) (K220262) | Siemens Healthcare Diagnostics, Inc. | 2022-08-26 |
| Elecsys BRAHMS PCT (K173927) | Roche Diagnostics | 2018-07-06 |
| LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers (K173683) | DiaSorin, Inc. | 2018-02-27 |
| Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set (K172713) | Fujirebio Diagnostics,Inc. | 2017-12-10 |
| ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls (K170652) | Fisher Diagnostics | 2017-06-01 |
| B R A H M S PCT sensitive KRYPTOR (K171338) | Brahms GmbH | 2017-05-31 |
| VIDAS B.R.A.H.M.S. PCT (PCT) (K162827) | bioMerieux, Inc. | 2017-02-23 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S007) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S006) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs / Elecsys HBs II (P190034/S009) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs II (P190034/S008) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBe (P190005/S005) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007) | Roche Diagnostics | 2024-07-23 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005) | Roche Diagnostics | 2024-05-01 |