(71 days)
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.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "Pronto Dry™". It does not contain information about acceptance criteria or a study proving the device meets said criteria in the way a modern AI/software as a medical device (SaMD) submission would.
This letter is dated June 22, 1999, and relates to a device for detecting Helicobacter pylori. The approval is based on "substantial equivalence" to legally marketed predicate devices, which was a common regulatory pathway at that time, especially for Class I devices like this one (Product Code: LYR). This type of clearance typically relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or different technological characteristics but with data demonstrating the device is as safe and effective as the predicate and does not raise different safety or effectiveness questions.
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, rather than detailed performance study results against specific acceptance criteria for a new, complex algorithm or AI system.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes extending to the right.
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.
{1}------------------------------------------------
Page 2
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 (770)488-7655.
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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
{2}------------------------------------------------
Page 1 of 1
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)
§ 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).