Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5
FDA 510(k) K160729 · Roche Diagnostics
510(k) numberK160729
Submission
- Device name
- Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- March 16, 2016
- Decision date
- June 13, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PMT – Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3215
- Specialty
- Microbiology
An assay used to determine the level of procalcitonin (PCT) in human serum and plasma as an aid in assessing the mortality for patients diagnosed with severe sepsis or septic shock.
Other 510(k)s with product code PMT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K200236 | VITROS BRAHMS PCT Reagent Pack and CalibratorsPMT · Traditional | Ortho Clinical Diagnostics | 02/25/2020SE |
| K181002 | Atellica IM BRAHMS Procalcitonin (PCT)PMT · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/16/2018SE |
| K160911 | Vidas B.R.A.H.M.S. PCT (PCT)PMT · Traditional | bioMerieux, Inc. | 06/28/2016SE |
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Questions and answers
When was Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 cleared by the FDA?
Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 (K160729) received a 510(k) decision of Substantially Equivalent on June 13, 2016, 89 days after the submission was received.
What is the product code of K160729?
The FDA product code is PMT – Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens, a Class II (moderate risk) device regulated under 21 CFR 866.3215.