MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT

K952220 · Meretek Diagnostics, Inc. · LYR · Sep 17, 1996 · Microbiology

Device Facts

• Record ID: K952220
• Device Name: MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT
• Applicant: Meretek Diagnostics, Inc.
• Product Code: LYR · Microbiology
• Decision Date: Sep 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3110
• Device Class: Class 1

Device Story

The Meretek UBT™ is a diagnostic device used to detect the presence of Helicobacter pylori in the human stomach. The system utilizes a drug component, Pranactin™ (13C-Urea), which is ingested by the patient. If H. pylori is present, the urease enzyme produced by the bacteria hydrolyzes the 13C-urea into 13CO2, which is then absorbed into the blood and exhaled in the breath. The device collects breath samples from the patient, which are then analyzed to measure the ratio of 13CO2 to 12CO2. The resulting data allows clinicians to diagnose H. pylori infection. The device is intended for use in a clinical setting by healthcare professionals.

Technological Characteristics

The device functions as an in vitro diagnostic system for breath analysis. It incorporates a drug component (13C-Urea) for metabolic testing. Technical specifications regarding materials, sensing principles, or software architecture are not detailed in the provided documentation.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850
SEP 17 1996

Ms. Claudia T. Hitchcock
Meretek Diagnostics, Inc.
1709 Dryden Road
Suite 1513
Houston, Texas 77030

Re: K952220
MERETEK UBT™
Regulatory Class: I
Product Code: LYR
Dated: June 28, 1996
Received: June 28, 1996

Dear Ms. Hitchcock:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

In addition, we have determined that your product contains the following component subject to regulation as drugs: Pranactin™ (¹³C-Urea-125 mg).

Our substantially equivalent determination does not apply to the drug component (NDA 20-586) of your product. For information on applicable Agency requirements for marketing this product, we suggest you contact:

David W. Feigal, Jr., M.D., M.P.H.
Acting Director
Office of Drug Evaluation IV
Center for Drug Evaluation and Research
Food and Drug Administration
9201 Corporate Boulevard
Rockville, Maryland 20850
[phone]

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the

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Page 2 - Ms. Claudia T. Hitchcock

Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the *Federal Register*. Please note: this response to your premarket notification submission does not affect any obligation you might have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification although we recommend that you first contact the Center for Drug Evaluation and Research before marketing your drug component. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA *approves* your device. Therefore, you may not promote or in any way represent your device or its labeling as being *approved* by FDA. If you desire specific advice for your device on the labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), promotion, or advertising, please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone].

Sincerely yours,

Steven I. Gutman, M.D., M.B.A.
Director
Division of Clinical Laboratory Devices
Office of Device Evaluation
Center for Devices and
Radiological Health