Home / 510(k) Clearances / K091235

510(k) K091235

RAMP RSV ASSAY by Response Biomedical Corp. — Product Code GQG

K091235 is an FDA 510(k) premarket notification submitted by Response Biomedical Corp. for the device "RAMP RSV ASSAY". The FDA issued a decision of Substantially Equivalent on July 24, 2009. The device falls under product code GQG (Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus), a Class I device regulated under 21 CFR 866.3480. Response Biomedical Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2009
Date Received
April 27, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Device Class
Class I
Regulation Number
866.3480
Review Panel
MI
Submission Type

Other clearances by Response Biomedical Corp.

  • K093116 — MODIFICATION TO: RAMP INFLUENZA A/B ASSAY (October 21, 2009)
  • K063662 — RAMP NT-PROBNP ASSAY (July 21, 2008)
  • K071591 — RAMP INFLUENZA A/B ASSAY (April 16, 2008)
  • K033747 — RAMP CK-MB ASSAY (May 17, 2004)
  • K033745 — RAMP TROPONIN I ASSAY (May 17, 2004)
  • K012040 — RAMP MYOGLOBIN ASSAY (December 18, 2001)

Other clearances for product code GQG

  • K253318 — Clungene RSV Antigen Rapid Test (January 30, 2026)
  • K240280 — Nano-Check™ RSV Test (July 30, 2024)
  • K162911 — Sofia RSV FIA on Sofia 2 analyzer (February 22, 2017)
  • K133140 — BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV (November 15, 2013)
  • K132456 — BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV (November 7, 2013)
  • K130398 — SOFIA(R) RSV FIA (August 13, 2013)
  • K121633 — BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV (September 18, 2012)
  • K101918 — QUICKVUE RSV 10 (September 24, 2010)
  • K101514 — BD DIRECTIGEN EZ RSV (July 9, 2010)
  • K070747 — QUICK VUE RSV TEST, MODELS 20193, 20199 (April 23, 2007)

FDA data resources