B R A H M S PCT sensitive KRYPTOR
FDA 510(k) K171338 · Brahms GmbH
510(k) numberK171338
Submission
- Device name
- B R A H M S PCT sensitive KRYPTOR
- Applicant
- Brahms GmbH
Henningsdorf, DE - Received
- May 8, 2017
- Decision date
- May 31, 2017
- 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 |
| K192815 | Elecsys BRAHMS PCTPRI · Traditional | Roche Diagnostics | 03/09/2020SE |
| 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 |
| K162827 | Vidas B.R.A.H.M.S. PCT (PCT)PRI · Traditional | bioMerieux, Inc. | 02/23/2017SE |
Questions and answers
When was B R A H M S PCT sensitive KRYPTOR cleared by the FDA?
B R A H M S PCT sensitive KRYPTOR (K171338) received a 510(k) decision of Substantially Equivalent on May 31, 2017, 23 days after the submission was received.
What is the product code of K171338?
The FDA product code is PRI – Procalcitonin Assay, a Class II (moderate risk) device regulated under 21 CFR 866.3215.