Great Basin Staph ID/R Blood Culture Panel— 510(k) K152470

Clearance details

Applicant

Great Basin Scientific, Inc.

Product code

Code PAM

Device class

Class 2

Regulation

21 CFR 866.3365

Advisory panel

Microbiology

Date received

2015-08-31

Decision date

2016-03-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Salt Lake City, UT, US

• K254194 — QIAstat-Dx BCID GPF Plus AMR Panel2026-08-06
• K243490 — LIAISON PLEX Gram-Positive Blood Culture Assay2025-06-06
• K181663 — ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel2018-12-20
• K163390 — iC-GPC Assay TM for use on the iC-SystemTM2017-08-08
• K122514 — VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST2012-09-19

• K163571 — Great Basin Stool Bacterial Pathogens Panel2017-07-12
• K170284 — Great Basin Bordetella Direct Test2017-03-31
• K152955 — Great Basin Shiga Toxin Direct Test2016-03-22

Death

6

Malfunction

598

Total

604

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1051-2017 — Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer System. The Staph lD/R Blood Culture Panel is capable of simultaneous detection and identification ol Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensrs and various Staphylococcus species to the genus level and the detection of the mecA gene for methicillin resistance from patient positive blood culture specimens.Class II·Terminated·Great Basin Scientific, Inc.·20161212

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152470.