MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT by MERETEK DIAGNOSTICS, INC.

The provided text is a 510(k) clearance letter from the FDA for a device called MERETEK UBT™. While it confirms the device's substantial equivalence and outlines regulatory requirements, it does not contain any information regarding the acceptance criteria for a study, nor does it present data from a study that proves the device meets those criteria.

The letter explicitly states: "Our substantially equivalent determination does not apply to the drug component (NDA 20-586) of your product." It then directs the manufacturer to contact the Center for Drug Evaluation and Research for information on applicable Agency requirements for marketing the drug component. This indicates that the clinical effectiveness and associated studies for the drug component, which is likely central to the device's function, would be handled under a separate NDA process, not detailed here.

Therefore, I cannot provide the requested information from the given text.

The document is solely a regulatory clearance letter and does not include scientific study details such as:

A table of acceptance criteria and the reported device performance: Not present.
Sample size used for the test set and the data provenance: Not present.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
Adjudication method: Not present.
Multi-reader multi-case (MRMC) comparative effectiveness study details: Not present.
Standalone performance study details: Not present.
Type of ground truth used: Not present.
Sample size for the training set: Not present.
How the ground truth for the training set was established: Not present.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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

K952220 Re: 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 we 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 provisions of the rise mond 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 (301) 827-2120

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 (1 remations 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)
Concessed and Charles (2) CMD increases (EDA will verify such assumptions Good Manufacturing Practic GMP inspections, FDA will verity ouch assumptions.
Part 820) and that, through periodic GMP inspections, FDA will verily onch assumptions. In addit Part 820) and that, through periodic GMP regulation may result in regulatory action. In addition,
Failure to comply with the GMP regulation may result in regulation. In add Failure to comply with the GMP regulation in regulation and oncernents concerning
the Food and Drug Administration (FDA) may publish further announcements on the Food and Drug Administration (FDA) now publish response to your premarket your device in the Federal Register. Please into response as you might have under section 531
notification submission does not affect any obligation you might tadjation Contr notification submission does not any bollgator you the games and the electronic Radiation Control
through 542 of the Act for devices under the Electronic Product Radiation Co through 542 of the Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k)
The Center for the first be areasmmend that you first contact the Center for D This letter will allow you to begin marketing your devices the Center for Drug
premarket notification although we recommend that you first comtact the Center of premarket notification although we recomment. An FDA finding of
Evaluation and Research before marketing your drug components in Evaluation and Research before marketing your ung componence device results in a
substantial equivalence of your device to a legally market, but it do substantial equivalence of your device to a legally inanced pleated to the market, but it does
classification for your device and permiss your device or in any way classification for your device and permits your cever, you may not promote or in any way
not mean that FDA approves your device annoved by FDA . If you desire specific not mean that FDA approves your device. Thereview by FDA. If you desire specific represent your device or its labeling regulation (21 CFR Part 801 and additionally 809.10
advice for your device on the labeling regulation (21 CFR Part 801 and additionally advice for your device on the labeling regulation (21 Circle ocontact the Office of
for in vitro diagnostic devices), promotion, or advertising, please contact the Office of for in vitro diagnostic devices), promotion, or are crising, productions.
Compliance, Promotion and Advertising Policy Staff (HFZ-302) at (301) 594-4639. Other Compliance, Promotion and Advertisibilities under the Act may be obtained from the general information on your responsibilities under the Act Hay 90 Count.
Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597.

Sincerely yours,

a. Ditran

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

Regulation Number and Section

§ 866.3110

Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter 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.(b)
Classification. Class I (general controls).