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510(k) K152470

Great Basin Staph ID/R Blood Culture Panel by Great Basin Scientific, Inc. — Product Code PAM

K152470 is an FDA 510(k) premarket notification submitted by Great Basin Scientific, Inc. for the device "Great Basin Staph ID/R Blood Culture Panel". The FDA issued a decision of Substantially Equivalent on March 25, 2016. The device falls under product code PAM (Gram-Positive Bacteria And Their Resistance Markers), a Class II device regulated under 21 CFR 866.3365. Great Basin Scientific, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2016
Date Received
August 31, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gram-Positive Bacteria And Their Resistance Markers
Device Class
Class II
Regulation Number
866.3365
Review Panel
MI
Submission Type

A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.

Other clearances by Great Basin Scientific, Inc.

  • K163571 — Great Basin Stool Bacterial Pathogens Panel (July 12, 2017)
  • K170284 — Great Basin Bordetella Direct Test (March 31, 2017)
  • K152955 — Great Basin Shiga Toxin Direct Test (March 22, 2016)
  • DEN120013 — PORTRAIT ANALYZER (April 30, 2012)

Other clearances for product code PAM

  • K243490 — LIAISON PLEX Gram-Positive Blood Culture Assay (June 6, 2025)
  • K181663 — ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel (December 20, 2018)
  • K163390 — iC-GPC Assay TM for use on the iC-SystemTM (August 8, 2017)
  • K122514 — VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST (September 19, 2012)
  • DEN120014 — VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) (June 26, 2012)

FDA data resources