ImmunoCard STAT! HpSA

K153661 · Meridian Bioscience, Inc. · LYR · Mar 14, 2016 · Microbiology

Device Facts

• Record ID: K153661
• Device Name: ImmunoCard STAT! HpSA
• Applicant: Meridian Bioscience, Inc.
• Product Code: LYR · Microbiology
• Decision Date: Mar 14, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3110
• Device Class: Class 1

Intended Use

The ImmunoCard STAT! HpSA is a rapid in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. The stool antigen detection is intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori stool antigen following treatment. Conventional medical practice recommends that testing by any method to confirm loss of antigen be done at least four weeks following completion of therapy.

Device Story

Rapid lateral flow immunoassay for qualitative detection of H. pylori antigens in human stool. Device consists of chromatography strips in plastic frame; utilizes dissociated monoclonal anti-H. pylori capture antibody and latex-conjugated detector antibodies. User adds stool sample to diluent; dispenses into device window. Antigen binds to detector antibody-latex conjugate; complex captured by membrane-bound antibody, forming visible pink/red line. Control line (blue) confirms adequate flow. Visual interpretation by clinician. Results aid in H. pylori infection diagnosis and post-treatment monitoring. Benefits include rapid, point-of-care assessment of infection status.

Clinical Evidence

Bench testing only. Reproducibility study across three sites using 90 contrived specimens showed 98.9% total agreement for moderate positives and 100% for low positives. Method comparison study against predicate device (n=150) showed 98.3% positive agreement and 98.9% negative agreement. Analytical specificity testing confirmed no cross-reactivity with 34 bacterial, viral, or yeast strains. Interfering substances (antacids, blood, fat, etc.) showed no effect on results.

Technological Characteristics

Rapid immunochromatographic assay for qualitative detection of H. pylori antigens in stool. Device is a standalone, non-automated diagnostic test.

Indications for Use

Indicated for the qualitative detection of Helicobacter pylori antigens in human stool to aid in the diagnosis of H. pylori infection and to monitor the loss of antigen following treatment in patients.

Regulatory Classification

Identification

Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify Campylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases. Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.

Submission Summary (Full Text)

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

March 14, 2016

MERIDIAN BIOSCIENCE, INC SUSAN ROLIH EVP, REGULATORY AND QUALITY SYSTEMS 3471 RIVER HILLS DRIVE CINCINNATI OH 45244

Re: K153661

Trade/Device Name: ImmunoCard STAT! HpSA Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter fetus serological reagents Regulatory Class: I Product Code: LYR Dated: December 18, 2015 Received: December 21, 2015

Dear Ms. Rolih:

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,

## Ribhi Shawar -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) K153661

Device Name

ImmunoCard STAT! HpSA

Indications for Use (Describe)

The ImmunoCard STAT! HpSA is a rapid in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. The stool antigen detection is intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori stool antigen following treatment. Conventional medical practice recommends that testing by any method to confirm loss of antigen be done at least four weeks following completion of therapy.

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

| <div> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|----------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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