Great Basin Staph ID/R Blood Culture Panel
FDA 510(k) K152470 · Great Basin Scientific, Inc.
510(k) numberK152470
Submission
- Device name
- Great Basin Staph ID/R Blood Culture Panel
- Applicant
- Great Basin Scientific, Inc.
Salt Lake City, UT, US - Received
- August 31, 2015
- Decision date
- March 25, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PAM – Gram-Positive Bacteria And Their Resistance Markers
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3365
- Specialty
- Microbiology
A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.
Other 510(k)s with product code PAM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254194 | QIAstat-Dx BCID GPF Plus AMR PanelPAM · Traditional | QIAGEN GmbH | 08/06/2026SE |
| K243490 | LIAISON PLEX Gram-Positive Blood Culture AssayPAM · Traditional | Luminex Corporation | 06/06/2025SE |
| K181663 | ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) PanelPAM · Traditional | Genmark Diagnostics, Incorporated | 12/20/2018SE |
| K163390 | iC-GPC Assay TM for use on the iC-SystemTMPAM · Traditional | Icubate, Inc. | 08/08/2017SE |
| K122514 | Verigene Gram-Positive Blood Culture (Gc-Gp) Nucleic Acid TestPAM · Traditional | Nanosphere, Inc. | 09/19/2012SE |
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Questions and answers
When was Great Basin Staph ID/R Blood Culture Panel cleared by the FDA?
Great Basin Staph ID/R Blood Culture Panel (K152470) received a 510(k) decision of Substantially Equivalent on March 25, 2016, 207 days after the submission was received.
What is the product code of K152470?
The FDA product code is PAM – Gram-Positive Bacteria And Their Resistance Markers, a Class II (moderate risk) device regulated under 21 CFR 866.3365.