QZX — Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing Class II

FDA Device Classification

Classification Details

Product Code: QZX
Device Class: Class II
Regulation Number: 866.1650
Submission Type
Review Panel: MI
Medical Specialty: Microbiology
Implant: No

Definition

Processing device that includes associated reagents, when applicable, that is intended to recover microbes from positive blood cultures for inoculum preparation. The prepared inoculum is intended for subsequent use in antimicrobial susceptibility testing.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K244044	selux diagnostics	PBC Separator with Selux AST System	March 28, 2025
K223493	selux diagnostics	PBC Separator with Selux AST System	February 15, 2024
K231536	avails medical	eQUANT System	February 8, 2024