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510(k) K240280

Nano-Check™ RSV Test by Nano-Ditech Corporation — Product Code GQG

K240280 is an FDA 510(k) premarket notification submitted by Nano-Ditech Corporation for the device "Nano-Check™ RSV Test". The FDA issued a decision of Substantially Equivalent on July 30, 2024. 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. Nano-Ditech Corporation has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2024
Date Received
February 1, 2024
Clearance Type
Dual Track
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 Nano-Ditech Corporation

  • K252283 — Nano-Check Influenza A+B Test (January 15, 2026)
  • K243561 — Nano-Check Influenza+COVID-19 Dual Test (June 17, 2025)
  • K231187 — Nano-Check™ COVID-19 Antigen Test (January 23, 2024)
  • K102441 — NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN (October 20, 2010)
  • K102131 — NANO-CHECK AMI CTNI CARDIAC MARKER TEST (October 20, 2010)

Other clearances for product code GQG

  • K253318 — Clungene RSV Antigen Rapid Test (January 30, 2026)
  • 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)
  • K091235 — RAMP RSV ASSAY (July 24, 2009)
  • K070747 — QUICK VUE RSV TEST, MODELS 20193, 20199 (April 23, 2007)

FDA data resources