(88 days)
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.
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.
The QIAGEN GmbH Rotor-Gene® Q MDx is a real-time PCR analyzer intended for in vitro diagnostic use with FDA cleared or approved nucleic acid tests in clinical laboratories. As an instrument, its performance is assessed in conjunction with specific assays. The provided summary focuses on the instrument itself and refers to a separate submission for the assay's performance.
Here's an analysis of the provided information based on your request:
1. A table of acceptance criteria and the reported device performance
The provided document describes the device, its intended use, and notes that the analytical and clinical performance of the Rotor-Gene Q MDx instrument is assessed for each assay to be run on this system. It explicitly states that the artus® Infl A/B RG RT-PCR assay is being submitted separately and refers to that submission for detailed performance data.
Therefore, specific acceptance criteria and reported device performance for the Rotor-Gene Q MDx instrument in isolation (e.g., regarding thermal cycling uniformity or detection sensitivity as inherent characteristics of the instrument) are not detailed in this document. The performance metrics listed are for the assay that runs on the instrument.
| Acceptance Criteria (for the instrument itself) | Reported Device Performance |
|---|---|
| Not explicitly detailed in this document for the instrument in isolation. Performance is linked to specific assays. | Not explicitly detailed in this document for the instrument in isolation. Assessed as part of each assay's submission. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to the artus® Infl A/B RG RT-PCR assay 510(k) submission for full testing details, which includes "Testing of prospectively collected and banked specimens."
- Sample Size for Test Set: Not specified in this document. It would be in the assay's submission.
- Data Provenance: "prospectively collected and banked specimens." Country of origin is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the given document. It would typically be detailed in the specific assay's submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the given document. It would typically be detailed in the specific assay's submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The Rotor-Gene Q MDx is a real-time PCR instrument, not an AI software or imaging device used by human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The Rotor-Gene Q MDx is an instrument that performs real-time PCR. Its performance is inherent to its functionality (thermal cycling, fluorescence detection) when used with an assay. The concept of "standalone algorithm performance" without human intervention, as typically understood in AI-based devices, does not directly apply here in the same way. The instrument itself operates independently once a user initiates a run.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the associated artus® Infl A/B RG RT-PCR assay, the document indicates "Testing of prospectively collected and banked specimens." While the specific "ground truth" method (e.g., culture, another FDA-approved PCR test, clinical diagnosis) is not detailed in this document, it implies clinical samples with a reference standard.
8. The sample size for the training set
This information is not provided in the given document. For a PCR instrument, the concept of a "training set" in the context of machine learning (AI) is generally not applicable. Instead, the instrument's design and calibration are based on engineering principles and verified through analytical studies. For the assay run on the instrument, there would be analytical validation data (e.g., sensitivity, specificity, LOD) established using various samples, but these are not typically referred to as a "training set."
9. How the ground truth for the training set was established
As noted in point 8, the concept of a "training set" and associated "ground truth" as typically used for AI devices is not directly applicable to this PCR instrument. Any "ground truth" would be related to the analytical and clinical validation of the assays running on the instrument, and those details are referred to a separate submission.
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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: +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.
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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 (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
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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
§ 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.