510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101855Substantially Equivalent

Profast+ Assay

Gen-Probe Prodesse, Inc., Waukesha WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101855 is the FDA 510(k) clearance record for PROFAST+ ASSAY, a class II device, cleared for Gen-Probe Prodesse, Inc. on under FDA product code OQW (2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification). FDA's definition for product code OQW reads: "2009 H1N1 influenza virus detection and identification reagents are used to directly detect and differentiate the 2009 H1N1 influenza virus in human respiratory specimens". FDA records list 10 510(k) clearances for Gen-Probe Prodesse, Inc., from to . As of , FDA records show no recalls naming K101855.

Clearance record

Decision date
Received
(22 days to decision)
Product code
OQW 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
Regulation
21 CFR 866.3332
Device class
Class II
Review panel
Microbiology
Applicant
Gen-Probe Prodesse, Inc. W229n1870 Westwood Dr., Waukesha WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OQW

Trailing 12 months

FDA records hold no clearances under product code OQW in the trailing twelve months.

FDA records show no clearances under product code OQW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OQW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260