TRU Legionella

K163273 · Meridian Bioscience, Inc. · MJH · Feb 21, 2017 · Microbiology

Device Facts

• Record ID: K163273
• Device Name: TRU Legionella
• Applicant: Meridian Bioscience, Inc.
• Product Code: MJH · Microbiology
• Decision Date: Feb 21, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3300
• Device Class: Class 2

Intended Use

The TRU LEGIONELLA® assay is an in vitro, rapid, lateral-flow immunoassay for the qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine specimens. It is designed to test specimens from patients with symptoms of pneumonia. Test results are to be used as an aid in diagnosis of Legionella pneumophila serogroup 1 infection. A negative result does not preclude infection with Legionella pneumophila serogroup 1. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures.

Device Story

TRU LEGIONELLA® is a rapid, lateral-flow immunoassay for qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine. Device operates via immunochromatographic principle; antigen in urine sample binds to labeled antibodies on test strip, producing visible line if positive. Intended for use in clinical settings by healthcare professionals as an aid in diagnosing Legionella infection. Results are interpreted visually by the clinician and used alongside patient clinical evaluation and other diagnostic procedures to guide clinical decision-making. Benefits include rapid identification of Legionella pneumophila serogroup 1, facilitating timely clinical management of pneumonia patients.

Clinical Evidence

Bench testing only. Verification studies compared modified device performance against the original configuration using fresh and frozen urine specimens (positive/negative). Accelerated stability testing performed per ISO 23640. All specimens produced expected results, confirming agreement with the original product configuration. No clinical trial data required for this modification.

Technological Characteristics

Lateral-flow immunoassay; qualitative detection of Legionella pneumophila serogroup 1 antigen in urine. Visual interpretation of test strip.

Indications for Use

Indicated for qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine specimens from patients with pneumonia symptoms. Used as an aid in diagnosis; negative results do not rule out infection. For prescription use only.

Regulatory Classification

Identification

Haemophilus spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye, that are used in serological tests to identify Haemophilus spp. directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Haemophilus and provides epidemiological information on diseases cause by these microorganisms. Diseases most often caused by Haemophilus spp. include pneumonia, pharyngitis, sinusitis, vaginitis, chancroid venereal disease, and a contagious form of conjunctivitis (inflammation of eyelid membranes).

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 § 866.9.

Submission Summary (Full Text)

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February 21, 2017

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

Public Health Service

## MERIDIAN BIOSCIENCE, INC. LAUREN DAVIS REGULATORY AFFAIRS AND DESIGN ASSURANCE ASSOCIATE 3471 RIVER HILLS DRIVE CINCINNATI OH 45244

Re: K163273

Trade/Device Name: Legionella. Spp., Elisa Regulation Number: 21 CFR 866.3300 Regulation Name: Haemophilus spp. serological reagents Regulatory Class: II Product Code: MJH Dated: January 20, 2017 Received: January 23, 2017

Dear Ms. Davis:

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

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

Sincerely yours.

# Kristian M. Roth -S

For: 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 TRU LEGIONELLA®

Indications for Use (Describe)

The TRU LEGIONELLA® assay is an in vitro, rapid, lateral-flow immunoassay for the qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine specimens from patients with symptoms of pneumonia. Test results are to be used as an aid in diagnosis of Legionella serogroup 1 infection. A negative result does not preclude infection with Legionella pneumophila serogroup 1. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures.

| Type of Use (Select one or both, as applicable) | |
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> Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### FOR FDA USE ONLY

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

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