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510(k) K091766

CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 by Binax, Inc. — Product Code MYI

K091766 is an FDA 510(k) premarket notification submitted by Binax, Inc. for the device "CLEARVIEW EXACT PBP2A TEST, MODEL 891-000". The FDA issued a decision of Substantially Equivalent on February 24, 2010. The device falls under product code MYI (System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies), a Class II device regulated under 21 CFR 866.1640. Binax, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2010
Date Received
June 17, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

Other clearances by Binax, Inc.

  • K090301 — BINAXNOW PBP2A TEST, MODEL 890-000 (April 14, 2010)
  • K090964 — BINAXNOX STAPHYLOCOCCUS AUREUS TEST (December 16, 2009)
  • K091489 — CLEARVIEW ADVANCED STREP A , MODEL 737-430 (September 4, 2009)
  • K083744 — BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 (September 1, 2009)
  • K092223 — MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST (August 12, 2009)
  • K080003 — BINAXNOW G6PD TEST (October 23, 2008)
  • K062109 — BINAXNOW INFLUENZA A & B TEST (November 9, 2006)
  • K053126 — BINAXNOW INFLUENZA A & B TEST (November 30, 2005)
  • K041049 — BINAXNOW INFLUENZA A & B TEST (August 10, 2004)
  • K032166 — BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PA (October 21, 2003)

Other clearances for product code MYI

  • K140619 — MECA XPRESSFISH (October 10, 2014)
  • K133851 — ALERE PBP2A SA/CONS CULTURE COLONY TEST (September 3, 2014)
  • K121905 — ALERE PBP2A TEST (July 26, 2012)
  • K090301 — BINAXNOW PBP2A TEST, MODEL 890-000 (April 14, 2010)
  • K062864 — MASTALEX -MRSA, MODEL RST501 (October 18, 2006)
  • K011710 — OXOID PBP2 1 LATEX AGGLUTINATION TEST (April 2, 2002)
  • K011400 — MRSA-SCREEN (March 27, 2002)
  • K010858 — VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION (May 24, 2001)
  • K990640 — VELOGENE RAPID MRSA IDENTIFICATION ASSAY (July 9, 1999)

FDA data resources