QUINTEST

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION Bayer Corporation David L. Mirabell Regulatory Affairs Administrator 3525 North Regal St. Spokane, Washington 99207 November 1, 2024 Re: K953939 Trade/Device Name: QUINTEST™ Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: SCL Dear David L. Mirabell: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated November 13, 1995. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code SCL. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact David Wolloscheck, OHT3: Office of GastroRenal, OB-Gyn, General Hospital and Urology Devices, 301-796-1480, David.Wolloscheck@fda.hhs.gov. Sincerely, David Wolloscheck -S David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices and Human Factors OHT3: Office of GastroRenal, OB-Gyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} [LOGO] DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service NOV 13 1995 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856 Mr. Dave L. Mirabell Regulatory Affairs Administrator Bayer Corporation Pharmaceutical Division N. 3525 Regal Spokane, Washington 99207 Re: K953939 Trade Name: QUINTEST™ Regulatory Class: Unclassified Product Code: LDH Dated: August 11, 1995 Received: August 15, 1995 Dear Mr. Mirabell: 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 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 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 sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations. {2} Page 2 - Mr. Mirabell This letter immediately will allow you to begin marketing your device as described in your 510(k) premarket notification. 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 our 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-300) at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597. Sincerely yours, Timothy A. Ulatowski Acting Director Pilot Division Office of Device Evaluation Center for Devices and Radiological Health 2 {3} K953939 304 # **510(k) SUMMARY** 1: Aug-95 Bayer Corporation Pharmaceutical Division N. 3525 Regal Spokane, WA. 99207 Contact Person: Dave Mirabell Phone: (509) 489-5656 Fax: (509) 484 -4320 Device Name: A. Trade name - QUINTEST™ a sterilized, five probed device used to perform puncture skin tests. A companion device named QUINTEST™ Tray serves as the allergen repository/storage and dispensing component. B. Common/usual name - multiple skin test device C. Classification name - puncture skin test device We claim that QUINTEST™ is substantially equivalent in design, composition, and function to the Greer DermaPIK® System. Both the DermaPIK® and QUINTEST™ are designed to perform epicutaneous allergenic extract skin tests. Both devices are designed to abrade/traumatize the epidermis without drawing blood and both accomplish this task when used as directed. QUINTEST™ skin test device is designed to apply test extract using the puncture technique. DermaPIK® instructions indicate it can be used for puncture and/or scratch technique. QUINTEST™ can perform five tests per testing device, whereas DermaPIK® performs one test per testing device. All components, of DermaPIK® and QUINTEST™, which either come in contact with the patient or with the extract are sterilized. All components of both are made of medical grade plastics with the action end of the QUINTEST™ device having a medical grade stainless steel lancet embedded into the plastic testing probe. Components of both devices are disposable and cannot be effectively sterilized and reused. QUINTEST™ System consists of two components: The QUINTEST™ skin test device and a tray that holds the allergenic extracts. The QUINTEST™ device is a molded plastic handle with five testing probes. Inserted into each testing probe is a stainless steel lancet tip that protrudes from the probe enough to give the proper testing depth. The QUINTEST™ trays are designed with ten wells to hold the testing extract. The testing device probes are submersed in the extract containing wells, extract adsorbs to the tip, and the device is ready to perform a skin test. Although the tray can be used for a week and then discarded, the QUINTEST™ device is to be used once and discarded in a sharps container. 227 {4} 305 The DermaPIK® probe accomplishes penetration by means of six small plastic tips. The QUINTEST™ accomplishes penetration by means of a stainless steel lancet embedded in a plastic probe (five probes per device). The end result with both devices is the same - administration of a small amount of test substance to the epicutaneous areas. Clinical tests have shown that the performance characteristics of the two tests are equivalent. Five tests on the arm and five on the back were performed with histamine 1.8 mg base/mL on each of 40 subjects (10 atopic and 10 non-atopic at each of two study centers). In general, DermaPIK® produced larger skin test responses than QUINTEST™. Classifying a positive test with QUINTEST™ as one in which the mean wheal of the five tests was at least 3mm, 90% of the tests on the arm and 95% of the tests on the back were positive. Classifying a positive test with DermaPIK® as one in which either the mean wheal or the mean erythema of the five tests was > 6mm, 97% of the tests on the arm and back were positive. Replicates of 50% glycerin were tested as described above on the same forty subjects. Using the same criteria specified for a positive test, 97% of the tests on the arm and 95% of the tests on the back were negative with QUINTEST™ and 95% of the tests on the arm and 87% of the tests on the back were negative with DermaPIK®. In summary, the two devices are substantially equivalent in their ability to administer test substances epicutaneously. y:\trk\510k July 24, 1995 221