PRONTO DRY

K991248 · Medical Instruments Corporation Mic AG · LYR · Jun 22, 1999 · Microbiology

Device Facts

• Record ID: K991248
• Device Name: PRONTO DRY
• Applicant: Medical Instruments Corporation Mic AG
• Product Code: LYR · Microbiology
• Decision Date: Jun 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3110
• Device Class: Class 1

Intended Use

Pronto Dry is intended for use for the detection of urease enzyme in gastric musocal biopsy specimens for the presumptive determination of Helicobacter pylori symptomatic adult patients.

Device Story

Pronto Dry is an in vitro diagnostic test used to detect urease enzyme activity in gastric mucosal biopsy specimens. It is intended for use in symptomatic adult patients to provide a presumptive determination of Helicobacter pylori infection. The device is used in a clinical laboratory or medical setting by healthcare professionals. The presence of urease, produced by H. pylori, is detected via a colorimetric reaction in the biopsy specimen. The result assists clinicians in diagnosing H. pylori infection, which informs subsequent treatment decisions for gastric conditions.

Clinical Evidence

No clinical data provided in the document; the submission relies on the determination of substantial equivalence to legally marketed predicate devices.

Technological Characteristics

In vitro diagnostic test for urease enzyme detection in gastric biopsy specimens. Operates via colorimetric chemical reaction. Standalone diagnostic kit.

Indications for Use

Indicated for the detection of urease enzyme in gastric mucosal biopsy specimens for the presumptive determination of Helicobacter pylori in symptomatic adult patients. For in vitro diagnostic use only.

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 9200 Corporate Boulevard Rockville MD 20850

JUN 2 2 1999

Dr. John C. Matherly Chairman of the Board Medical Instruments Corporation POB 706 CH-4502 Solothurn Switzerland

Re: K991248 Trade Name: Pronto Dry™ Regulatory Class: I Product Code: LYR Dated: April 8, 1999 Received: April 12, 1999

Dear Dr. Matherly:

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 (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). 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.

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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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 sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours.

Steven Butman

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

Enclosure

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K991248 510(k) Number (if known):_

PRONTO DRY Device Name:_

Indications For Use:

: -

Pronto Dry is intended for use for the detection of urease enzyme in gastric musocal biopsy specimens for the presumptive determination of Helicobacter pylori symptomatic adult patients.

Note: for in vitro diagnostic use only.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woodley Dubois

(Division Sign-Off)
Division of Cmical Laboratory Devices
510(k) Number K991248

Prescription Use X
(Per 21 CFR 801.109)

OR

· Over-The-Counter Use____

(Optional Format 1-2-96)