Staphylococcus Quickfish BC

Q: What is the product code of K113371?

The FDA product code is NXX – Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus, a Class I (low risk) device regulated under 21 CFR 866.3700.

FDA 510(k) K113371 · Advandx, Inc.

Substantially Equivalent

510(k) numberK113371

Submission

Device name: Staphylococcus Quickfish BC
Applicant: Advandx, Inc.
Woburn, MA, US
Received: November 16, 2011
Decision date: April 3, 2012
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: NXX – Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
Device class: Class I (low risk)
Regulation: 21 CFR 866.3700
Specialty: Microbiology

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 part 866.9(c)(6).

Other 510(k)s with product code NXX

510(k)	Device	Applicant	Decision
K092166	S. Aureus/Cns Pna Fish, Model KT005NXX · Traditional	Advandx, Inc.	11/23/2009SE
K091827	S. Aureus Pna FishNXX · Traditional	Advandx, Inc.	08/18/2009SE
K060099	S. Aureus Pna FishNXX · Traditional	Advandx, Inc.	05/08/2006SE

More from Advandx, Inc.

510(k)	Device	Decision
K140619	Meca XpressfishMYI · Traditional	10/10/2014SE
K123418	Gram-Negative Quickfish BCJSS · Traditional	07/21/2013SE
K121991	Enterococcus Quickfish BCOAH · Traditional	01/07/2013SE
K101558	GNR Traffic Light Pna FishJSS · Traditional	12/16/2010SE
K093024	Yeast Traffic Light Pna FishNZS · Traditional	07/15/2010SE
K092784	C. Albicans/C. Glabrata Pna FishNZS · Traditional	03/12/2010SE
K092655	C. Albicans Pna FishNZS · Traditional	01/19/2010SE
K092236	E.Coli/P. Aeruginosa Pna FishJSS · Traditional	12/16/2009SE
K092166	S. Aureus/Cns Pna Fish, Model KT005NXX · Traditional	11/23/2009SE
K092393	Ek/P. Aeruginosa Pna FishJSS · Traditional	09/01/2009SE

Questions and answers

When was Staphylococcus Quickfish BC cleared by the FDA?

Staphylococcus Quickfish BC (K113371) received a 510(k) decision of Substantially Equivalent on April 3, 2012, 139 days after the submission was received.

What is the product code of K113371?

The FDA product code is NXX – Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus, a Class I (low risk) device regulated under 21 CFR 866.3700.