510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K113319Substantially Equivalent

Rotor-Gene Q Mdx

Qiagen, Gaithersburg MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113319 is the FDA 510(k) clearance record for ROTOR-GENE Q MDX, a class II device, cleared for QIAGEN GmbH on under FDA product code OOI (Real Time Nucleic Acid Amplification System). FDA's definition for product code OOI reads: "The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or...". FDA records list 26 510(k) clearances for QIAGEN GmbH, from to . As of , FDA records show one recall naming K113319.

Clearance record

Decision date
Received
(88 days to decision)
Product code
OOI Real Time Nucleic Acid Amplification System
Regulation
21 CFR 862.2570
Device class
Class II
Review panel
Clinical Chemistry
Applicant
QIAGEN GmbH 1201 Clopper Rd., Gaithersburg MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OOI

Trailing 12 months

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

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