ROTOR-GENE Q MDX

K113319 · QIAGEN GmbH · OOI · Feb 6, 2012 · Clinical Chemistry

Device Facts

• Record ID: K113319
• Device Name: ROTOR-GENE Q MDX
• Applicant: QIAGEN GmbH
• Product Code: OOI · Clinical Chemistry
• Decision Date: Feb 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2570
• Device Class: Class 2

Intended Use

The Rotor-Gene Q MDx instrument with Rotor-Gene Q software version 2.1.0 or higher is a real-time nucleic acid amplification and detection system which measures nucleic acid signals from amplified DNA using fluorescent detection. The Rotor-Gene Q MDx instrument is intended for in vitro diagnostic use with FDA cleared or approved nucleic acid tests in clinical laboratories.

Device Story

Rotor-Gene Q MDx is a real-time PCR analyzer for thermal cycling and detection of nucleic acid amplicons. Device uses centrifugal rotary design; samples spin at 400 rpm in a low-mass-forced air oven to ensure thermal uniformity, prevent condensation, and remove air bubbles. During rotation, tubes pass an optical excitation source (LED) and detection zone; fluorescence is excited and collected by a photomultiplier. Device operates via assay-specific locked analysis templates that restrict the GUI to required workflow parameters. Used in clinical laboratories by trained personnel. Output consists of quantitative or qualitative nucleic acid detection data. Benefits include automated, standardized amplification and detection for IVD assays. Instrument supports six excitation/emission channels. Calibration is verified via Optical Temperature Verification (OTV) using thermochromatic liquid crystals.

Clinical Evidence

No clinical data provided for the instrument itself. Performance is assessed per specific assay run on the system. Analytical and clinical performance (LOD, LOB, reactivity, cross-reactivity, interference, precision, carry-over, reproducibility) is established via the specific artus Infl A/B RG RT-PCR assay 510(k) submission.

Technological Characteristics

Real-time PCR analyzer; centrifugal rotary thermal cycling design; fluorescent detection; air-based temperature control. Software-controlled (v2.1.0+). Standalone clinical laboratory instrument.

Indications for Use

Indicated for in vitro diagnostic use in clinical laboratories for real-time nucleic acid amplification and detection of amplified DNA using fluorescent detection, in conjunction with FDA cleared or approved nucleic acid tests.

Regulatory Classification

Identification

Instrumentation for clinical multiplex test systems is a device intended to measure and sort multiple signals generated by an assay from a clinical sample. This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. Such instrumentation may be compatible with more than one specific assay. The device includes a signal reader unit, and may also integrate reagent handling, hybridization, washing, dedicated instrument control, and other hardware components, as well as raw data storage mechanisms, data acquisition software, and software to process detected signals.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.” See § 862.1(d) for the availability of this guidance document.

The special control is FDA's guidance document entitled "Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems."

Predicate Devices

• Abbott m2000 System, specifically m2000rt (K092705)

Submission Summary (Full Text)

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# FEB - 6 2012

# QIAGEN GmbH Rotor-Gene® Q MDx Section 5.0, 510(k) Summary

# 510(k) Premarket Notification K113319 Page 1 of 2

# 510(k) SUMMARY

# 1. General Information

Submitted by:

QIAGEN GmbH Qiagen Strasse 1 Hilden, Germany 40724

Phone: [phone] Fax: [phone]

Contact Person:

Pit Muggli Garstligweg 8 Hombreckhtikon, Switzerland 8634

Phone: [phone] Fax: [phone] Email: [e-mail]

Date Prepared:

February 1, 2012

#### 2. Device Name

Rotor-Gene® Q MDx Trade Name: Common Name: Real Time Nucleic Acid Amplification System Classification Name: Instrumentation for Clinical Multiplex Test Systems, 21 CFR §862.2570

# 3. Predicate Device

| Manufacturer | Product Name | 510(k) No. |
|-----------------------|------------------------------------------------|------------|
| Abbott Molecular Inc. | Abbott® m2000™ System,<br>specifically m2000rt | K092705 |

#### 4. Device Description

The Rotor-Gene® Q MDx is a real-time PCR analyzer designed for rapid thermal cycling and real-time detection of PCR assays. The Rotor-Gene Q MDx uses a centrifugal rotary design for thermal cycling where each tube spins in a chamber of moving air, keeping all samples at a uniform temperature. Detection is performed as each tube aligns with the detection optics, where the sample is illuminated and the fluorescent signal is rapidly collected from a single, short optical pathway.

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# 5. Intended Use

The Rotor-Gene O MDx instrument with Rotor-Gene O software version 2.1.0 or higher is a real-time nucleic acid amplification and detection system which measures nucleic acid signals from amplified DNA using fluorescent detection.

The Rotor-Gene Q MDx instrument is intended for in vitro diagnostic use with FDA cleared or approved nucleic acid tests in clinical laboratories.

# 6. Technological Comparison

The Rotor-Gene Q MDx instrument and the Abbott m2000rt instrument are similar in the intended use, assay format, primary operational amplification and detection, and automation. The Rotor-Gene Q MDx and the Abbott m2000rt instrument differ in the heating method for amplification and amplification reaction volumes. While there are differences, these differences do not raise new types of safety and effectiveness questions.

### 7. Testing

Analytical and clinical performance of the Rotor-Gene O MDx instrument is assessed for each assay to be run on this system.

The artus® Infl A/B RG RT-PCR assay is being submitted separately, but concurrent with this RGQ instrument submission. Please refer to the artus® Infl A/B RG RT-PCR assay 510(k) submission for the artus® Infl A/B RG RT-PCR assay analytical and clinical testing which includes the following:

- Limit of Detection,
- Limit of Blank.
- Reactivity,
- Cross-reactivity,

: ' ,

- Interference,
- Precision,
- Carry-over / cross-contamination,
- Multi-center reproducibility, and
- Testing of prospectively collected and banked specimens.

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10903 New Hampshire Avenue Silver Spring, MD 20993

Oiagen GmbH c/o Melissa Mahall Director. Regulatory Affairs 1201 Clopper Road Gaithersburg, MD 20878

FEB - 6 2012

Re: K113319

Trade/Device Name: Rotor-Gene Q MDx Regulation Number: 21 CFR 862.2570 Regulation Name: Instrumentation for clinical multiplex test systems Regulatory Class: Class II Product Code: 001 Dated: October 21, 2011 Received: Nov. 10. 2011

Dear Ms. Mahall:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket

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notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Viacattyo

Sally A. Hoivat. M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

510(k) Number (if known): k113319

Rotor-Gene® Q MDx Device Name:

Sponsor Name: QIAGEN GmbH

Indications for Use:

The Rotor-Gene Q MDx instrument with Rotor-Gene Q software version 2.1.0 or higher is a real-time nucleic acid amplification and detection system which measures nucleic acid signals from amplified DNA using fluorescent detection.

The Rotor-Gene Q MDx instrument is intended for in vitro diagnostic use with FDA cleared or approved nucleic acid tests in clinical laboratories.

Prescription Use X (21 CFR 801 Subpart D)

And/Or

Over-The-Counter Use (21 CFR 807 Subpart C)

# Do Not Write Below This Line – Continue on Another Page if Needed

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Tamara V. Kiddle Q.
Division Sign-Off

Division Sign-On

Office of In Vitro Diagnostic Device Evaluation and Safety

K 113319