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510(k) K183573

Vstrip H. pylori Antigen Rapid Test by Panion & BF Biotech, Inc. — Product Code LYR

K183573 is an FDA 510(k) premarket notification submitted by Panion & BF Biotech, Inc. for the device "Vstrip H. pylori Antigen Rapid Test". The FDA issued a decision of Substantially Equivalent on March 14, 2019. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2019
Date Received
December 21, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Helicobacter Pylori
Device Class
Class I
Regulation Number
866.3110
Review Panel
MI
Submission Type

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  • K182559 — PREMIER Platinum HpSA PLUS (November 5, 2018)
  • K181464 — LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set (August 31, 2018)
  • K181400 — H. PYLORI CHEK™ (August 21, 2018)
  • K181379 — H. PYLORI QUIK CHEK (August 21, 2018)
  • K161139 — LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set (July 22, 2016)
  • K153661 — ImmunoCard STAT! HpSA (March 14, 2016)
  • K151935 — Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whol (August 12, 2015)

FDA data resources