(88 days)
Not Found
No
The summary describes a real-time PCR instrument and software for nucleic acid detection. There is no mention of AI or ML in the intended use, device description, or performance studies. The technology described is standard real-time PCR analysis.
No.
The device is described as a real-time nucleic acid amplification and detection system intended for in vitro diagnostic use, not for treating or diagnosing a disease or condition in a patient.
Yes
The device description states it is a "real-time nucleic acid amplification and detection system," and the intended use specifies it is "intended for in vitro diagnostic use." This clearly indicates its role in diagnosing medical conditions by analyzing biological samples.
No
The device description clearly states it is a "real-time PCR analyzer" and describes hardware components like a "centrifugal rotary design" and "detection optics." While it includes software, it is an instrument with physical components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "The Rotor-Gene Q MDx instrument is intended for in vitro diagnostic use with FDA cleared or approved nucleic acid tests in clinical laboratories."
- Function: The device is a real-time nucleic acid amplification and detection system that measures signals from amplified DNA using fluorescent detection. This is a core function of many IVD devices used for detecting pathogens, genetic markers, and other biological targets in patient samples.
- Intended User and Setting: The intended user is "clinical laboratories," which are the typical settings where IVD testing is performed.
- Performance Studies: The document mentions analytical and clinical performance studies being conducted for assays run on the system, which is a requirement for IVD devices.
- Predicate Device: The predicate device listed (K092705; Abbott® m2000™ System) is also a real-time PCR system used for in vitro diagnostic testing, further supporting the classification of this device as an IVD.
Therefore, based on the provided information, the Rotor-Gene Q MDx instrument is definitively an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
OOI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
in clinical laboratories.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.2570 Instrumentation for clinical multiplex test systems.
(a)
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.(b)
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.
0
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: +49 2103-29-0 Fax: +49 2103-29-2177
Contact Person:
Pit Muggli Garstligweg 8 Hombreckhtikon, Switzerland 8634
Phone: +41 (55) 2542-150 Fax: +41 (55) 2542-101 Email: pit.muggli@qiagen.com
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, | |
| 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.
1
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.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized design of a human figure, representing health and well-being. The seal is in black and white.
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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Page 2 –
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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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
4
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