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510(k) DEN120013

PORTRAIT ANALYZER by Great Basin Scientific — Product Code OMN

DEN120013 is an FDA 510(k) premarket notification submitted by Great Basin Scientific for the device "PORTRAIT ANALYZER". The FDA issued a decision of De Novo Granted on April 30, 2012. The device falls under product code OMN (C. Difficile Nucleic Acid Amplification Test Assay), a Class I device regulated under 21 CFR 866.2660. Great Basin Scientific has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
April 30, 2012
Date Received
March 2, 2012
Clearance Type
Post-NSE
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
C. Difficile Nucleic Acid Amplification Test Assay
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients.

Other clearances by Great Basin Scientific

  • K163571 — Great Basin Stool Bacterial Pathogens Panel (July 12, 2017)
  • K170284 — Great Basin Bordetella Direct Test (March 31, 2017)
  • K152470 — Great Basin Staph ID/R Blood Culture Panel (March 25, 2016)
  • K152955 — Great Basin Shiga Toxin Direct Test (March 22, 2016)

Other clearances for product code OMN

  • K113433 — SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT (April 4, 2012)
  • K110203 — XPERT C. DIFFICLE/EPI ASSAY (April 7, 2011)
  • K110012 — ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10 (February 24, 2011)
  • K100818 — ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTR (July 9, 2010)

FDA data resources