510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K092166Substantially Equivalent

S. Aureus/cns Pna Fish, Model Kt005

Advandx, Inc., Woburn MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K092166 is the FDA 510(k) clearance record for S. AUREUS/CNS PNA FISH, MODEL KT005, a class I device, cleared for Advandx, Inc. on under FDA product code NXX (Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus). FDA's definition for product code NXX reads: "The s. Aureus pna fish is a qualitative nucleic acid hybridization assay intended for presumptive identification of staphylococcus aureus from blood cultures with gram-positive cocci in clusters (gpcc). This device is not exempt per 21 cfr...". FDA records list 21 510(k) clearances for Advandx, Inc., from to . As of , FDA records show no recalls naming K092166.

Clearance record

Decision date
Received
(125 days to decision)
Product code
NXX Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
Regulation
21 CFR 866.3700
Device class
Class I
Review panel
Microbiology
Applicant
Advandx, Inc. 10a Roessler Rd., Woburn MA
510(k) summary
Statement
Third party review
No

Clearances, product code NXX

Trailing 12 months

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

FDA records show no clearances under product code NXX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NXX, 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