illumigene Mycoplasma DNA Amplification Assay

K152800 · Meridian Bioscience, Inc. · OZX · Oct 23, 2015 · Microbiology

Device Facts

• Record ID: K152800
• Device Name: illumigene Mycoplasma DNA Amplification Assay
• Applicant: Meridian Bioscience, Inc.
• Product Code: OZX · Microbiology
• Decision Date: Oct 23, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3980
• Device Class: Class 2

Indications for Use

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 amplification (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 Story

The illumigene Mycoplasma DNA amplification assay is an in vitro diagnostic test for detecting Mycoplasma pneumoniae DNA in throat and nasopharyngeal swabs. The device utilizes loop-mediated isothermal DNA amplification (LAMP) technology to target specific genomic segments of M. pneumoniae. The assay is performed on the illumipro-10 instrument, which automates the amplification and detection process. It is intended for use by laboratory professionals in hospital, reference, or state laboratory settings. The output is a qualitative result used by clinicians alongside clinical presentation and other laboratory findings to aid in diagnosing M. pneumoniae infection. It is not intended as the sole basis for patient management. The device benefits patients by providing a rapid, specific molecular diagnostic tool for identifying M. pneumoniae in upper respiratory tract samples.

Clinical Evidence

No clinical data provided in the document. The document focuses on the regulatory clearance of the assay as a qualitative in vitro diagnostic test.

Technological Characteristics

The device utilizes loop-mediated isothermal DNA amplification (LAMP) technology. It is designed for use with the illumipro-10 instrument. The assay is a qualitative nucleic acid amplification test (NAAT) for the detection of M. pneumoniae DNA. It is intended for professional use in centralized laboratory environments.

Indications for Use

Indicated for qualitative detection of Mycoplasma pneumoniae DNA in human throat and nasopharyngeal swabs from patients suspected of M. pneumoniae infection. Not for point-of-care use.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K152800

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.

Trade Name: illumigene Mycoplasma DNA Amplification Assay

510(k) number: K123423

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use.

3. A description of the device MODIFICATION(S), including sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

The submission includes modifications to the assay labeling that include the following:

A. Addition of Liquid Amies (without charcoal) non-nutritive transport medium as a swab transport media for specimen collection.

B. Removal of Moraxella catarrhalis, Nocardia asteroides and Coronavirus as potentially interfering microorganisms in the Limitation and Cross-reactivity/Microbial Interference sections of the package insert.

These labeling changes do not affect the intended use or the instructions for use. There were no modifications to the assay.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, claimed specimen types, and potentially interfering microorganisms.

SIMILARITIES

| ITEM | PREDICATE DEVICE: illumigene Mycoplasma DNA Amplification Assay K123423 | MODIFIED DEVICE |
| --- | --- | --- |
| Intended Use | 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 amplification (LAMP) technology to | Same |

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| | 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. | |
| --- | --- | --- |
| Technology | Loop-mediated amplification (LAMP) technology | Same |
| Sample Types | Human throat and nasopharyngeal swabs | Same |
| Target | DNA sequence of the Mycoplasma pneumoniae genome | Same |

## DIFFERENCES

| ITEM | PREDICATE DEVICE: illumigene Mycoplasma DNA Amplification Assay K123423 | MODIFIED DEVICE |
| --- | --- | --- |
| Claimed Transport Media | 0.85% Saline, M4, M4-RT, M5, or UTM-RT | Same, with the addition of Liquid Amies (without charcoal) non-nutritive transport media for specimen collection |
| Labeling Limitation Pertaining to | Labeling includes the following limitation: “There is potential for a false negative result in the presence of high | Limitation removed |

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| Microbial Interference | concentrations of Moraxella catarrhalis, Nocardia asteroides, or Coronavirus. For these three organisms, a false negative result was observed in only one of seven replicates with samples tested near the Limit of Detection during initial testing that were not confirmed with further testing.” | |
| --- | --- | --- |
| Labeling/Crossreactivity/Microbial Interference Study Section | Labeling includes the following statement regarding potential microbial interference: “Moraxella catarrhalis, Nocardia asteroides and Coronavirus produced unexpected results during initial testing that were not confirmed with further testing. For each organism, false-negative results occurred in one of seven replicates tested near the Limit of Detection.” | The statement regarding potential microbial interference is removed from the labeling. Moraxella catarrhalis, Nocardia asteroides and Coronavirus are added to the list of organisms determined to not crossreact or interfere with the illumigene Mycoplasma assay. |

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

A description of the Risk Analysis Method, the potential impact of the modification to the device and the results of the analysis were provided. Based on the risk analysis, the following analytical validation studies were performed to substantiate the labeling changes.

- Limit of Detection and Specimen Stability studies were conducted to support the use of Liquid Amies (without charcoal) transport media for swab specimens tested with the illumigene Mycoplasma DNA Amplification assay.
- An analytical study was conducted to demonstrate that high concentrations of Moraxella catarrhalis, Nocardia asteroides and Coronavirus do not negatively affect device performance.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.