The illumigene Mycoplasma DNA amplification assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in human throat and nasopharyngeal swabs obtained from patients suspected of having Mycoplasma pneumoniae infection.

The illumigene Mycoplasma assay utilizes loop-mediated isothermal DNA ampification (LAMP) technology to detect Mycoplasma pneumoniae by targeting a segment of the Mycoplasma pneumoniae genome.

Results from the illumigene Mycoplasma DNA amplification assay should be used in conjunction with clinical presentation, other laboratory findings, and epidemiological risk factors as an aid in the diagnosis of Mycoplasma infection and should not be used as the sole basis for treatment or other patient management. Positive results do not rule out co-infection with other organisms and negative results in persons with respiratory tract infections may be due to pathogens not detected by this assay. Lower respiratory tract infections due to M. pneumoniae may not be detected by this assay. If lower respiratory tract infection due to M. pneumoniae is suspected, additional laboratory testing using methods other than the illumigene Mycoplasma DNA Amplification Assay may be necessary.

illumigene Mycoplasma is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.

Device Description

The illumigene Mycoplasma assay utilizes loop-mediated isothermal DNA ampification (LAMP) technology to detect Mycoplasma pneumoniae by targeting a segment of the Mycoplasma pneumoniae genome.

AI/ML Overview

This document is a 510(k) premarket notification for the illumigene Mycoplasma DNA Amplification Assay. It primarily focuses on regulatory approval and does not contain detailed study information or acceptance criteria beyond the intended use and performance claims. Therefore, I cannot provide a comprehensive answer to your request based solely on this document.

However, I can extract the following relevant information:

Device Name: illumigene Mycoplasma DNA Amplification Assay
Intended Use: Qualitative in vitro diagnostic test for direct detection of DNA from Mycoplasma pneumoniae in human throat and nasopharyngeal swabs from patients suspected of having Mycoplasma pneumoniae infection.

To answer your questions completely, a more detailed study report (often called a "Summary of Safety and Effectiveness" or a "Device Description" document submitted with the 510(k)) would be needed. That report would contain the performance data and the specifics of the clinical study.

Given the information provided, here's what can be inferred or directly stated, with limitations:

1. A table of acceptance criteria and the reported device performance:

This document does not explicitly state specific acceptance criteria (e.g., minimum sensitivity or specificity targets) or present a table of reported device performance. It only states the intended use of the device.

2. Sample size used for the test set and the data provenance:

This document does not mention the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). These details would typically be found in the clinical study section of the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This document does not provide information on the number or qualifications of experts used to establish ground truth.

4. Adjudication method for the test set:

This document does not specify any adjudication method for the test set.

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:

This device is a DNA amplification assay, which is a laboratory diagnostic test, not an imaging device typically involving human "readers" or AI assistance in interpretation in the same way as radiology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Given it's an "illumigene Mycoplasma DNA Amplification Assay," this is inherently a standalone diagnostic test performed in a lab. The results are then interpreted by laboratory personnel and clinicians. It is a standalone algorithm/device in the sense that its performance evaluation would focus on its accuracy in detecting the target DNA, independent of human interpretation of complex images. The "human-in-the-loop" would be the clinician's use of the result in conjunction with other findings.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For a DNA amplification assay, the ground truth for measuring performance (sensitivity and specificity) would typically be established by a reference method, often another highly sensitive and specific molecular test (e.g., PCR with sequencing confirmation), or by culture, which is considered definitive for microbial identification. This document does not explicitly state the ground truth method.

8. The sample size for the training set:

This document does not mention a training set sample size. For a device like this, the "training" may refer to internal optimization and validation studies during development, not a formal external training set that would be documented in the same way as a machine learning algorithm's training set.

9. How the ground truth for the training set was established:

As above, this document does not provide information on how ground truth for any potential "training set" was established.

In summary, this regulatory notification provides minimal technical detail regarding performance studies. A full understanding would require access to the complete 510(k) submission, specifically the sections detailing analytical and clinical performance studies.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

MERIDIAN BIOSCIENCE, INC. STEFANIE JOHNS REGULATORY AFFAIRS AND DESIGN ASSURANCE ASSOCIATE 3471 RIVER HILLS DRIVE October 23, 2015 CINCINNATI OH 45244

Re: K152800

Trade/Device Name: illumigene Mycoplasma DNA Amplification Assay Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory viral panel multiplex nucleic acid assay Regulatory Class: II Product Code: OZX Dated: September 25, 2015 Received: September 28, 2015

Dear Ms. Johns:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Uwe Scherf -S

Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

illumigene Mycoplasma DNA Amplification Assay

Indications for Use (Describe)

The illumigene Mycoplasma assay utilizes loop-mediated isothermal DNA ampification (LAMP) technology to detect Mycoplasma pneumoniae by targeting a segment of the Mycoplasma pneumoniae genome.

illumigene Mycoplasma is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.

Type of Use (Select one or both, as applicable)

× Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Regulation Number and Section

§ 866.3980 Respiratory viral panel multiplex nucleic acid assay.

(a)
Identification. A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses:(1) Influenza A and Influenza B;
(2) Influenza A subtype H1 and Influenza A subtype H3;
(3) Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B;
(4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus;
(5) Human Metapneumovirus;
(6) Rhinovirus; and
(7) Adenovirus.
(b)
Classification. Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay;”
(2) For a device that detects and identifies Human Metapneumovirus, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays;” and
(3) For a device that detects and differentiates Influenza A subtype H1 and subtype H3, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.” See § 866.1(e) for the availability of these guidance documents.