VITROS BRAHMS PCT Reagent Pack and Calibrators
FDA 510(k) K200236 · Ortho Clinical Diagnostics
510(k) numberK200236
Submission
- Device name
- VITROS BRAHMS PCT Reagent Pack and Calibrators
- Applicant
- Ortho Clinical Diagnostics
Rochester, NY, US - Received
- January 30, 2020
- Decision date
- February 25, 2020
- 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 |
|---|---|---|---|
| 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 |
| K160729 | Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5PMT · Traditional | Roche Diagnostics | 06/13/2016SE |
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Questions and answers
When was VITROS BRAHMS PCT Reagent Pack and Calibrators cleared by the FDA?
VITROS BRAHMS PCT Reagent Pack and Calibrators (K200236) received a 510(k) decision of Substantially Equivalent on February 25, 2020, 26 days after the submission was received.
What is the product code of K200236?
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.