Elecsys BRAHMS PCT
FDA 510(k) K192815 · Roche Diagnostics
510(k) numberK192815
Submission
- Device name
- Elecsys BRAHMS PCT
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- October 1, 2019
- Decision date
- March 9, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PRI – Procalcitonin Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3215
- Specialty
- Microbiology
To aid in decision making on antibiotic therapy, including antibiotic initiation and discontinuation, for inpatients or patients in the Emergency Department, with suspected or confirmed lower respiratory tract infections (LRTI) defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD).
Other 510(k)s with product code PRI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220262 | Dimension EXL LOCI BRAHMS Procalcitonin (PCT)PRI · Traditional | Siemens Healthcare Diagnostics, Inc. | 08/26/2022SE |
| K173927 | Elecsys BRAHMS PCTPRI · Traditional | Roche Diagnostics | 07/06/2018SE |
| K173683 | LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN…PRI · Traditional | DiaSorin, Inc. | 02/27/2018SE |
| K172713 | Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT…PRI · Traditional | Fujirebio Diagnostics,Inc. | 12/10/2017SE |
| K170652 | ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S…PRI · Traditional | Fisher Diagnostics | 06/01/2017SE |
| K171338 | B R A H M S PCT sensitive KRYPTORPRI · Traditional | Brahms GmbH | 05/31/2017SE |
| K162827 | Vidas B.R.A.H.M.S. PCT (PCT)PRI · Traditional | bioMerieux, Inc. | 02/23/2017SE |
More from bioMerieux, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261686 | Elecsys Phospho-Tau (217P) PlasmaSET · Traditional | 08/19/2026SE |
| K252323 | cobas pulse blood glucose monitoring systemPZI · Dual Track | 06/12/2026SE |
| K252431 | Elecsys CalcitoninJKR · Traditional | 04/24/2026SE |
| K252280 | Elecsys Anti-SARS-CoV-2 SQVP · Traditional | 04/13/2026SE |
| K260049 | Elecsys Anti-HBc IgMSEI · Traditional | 04/07/2026SE |
| K260048 | Elecsys Anti-HAV IgMLOL · Traditional | 04/07/2026SE |
| K260046 | Elecsys Anti-HBc IISEI · Traditional | 04/07/2026SE |
| K260026 | Tina-quant Cardiac high sensitivity CRP IIINQD · Traditional | 04/02/2026SE |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…CEM · Traditional | 02/12/2026SE |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsCFR · Traditional | 02/12/2026SE |
Questions and answers
When was Elecsys BRAHMS PCT cleared by the FDA?
Elecsys BRAHMS PCT (K192815) received a 510(k) decision of Substantially Equivalent on March 9, 2020, 160 days after the submission was received.
What is the product code of K192815?
The FDA product code is PRI – Procalcitonin Assay, a Class II (moderate risk) device regulated under 21 CFR 866.3215.