LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384

{0}------------------------------------------------ DEC 14 1998 K984225 Image /page/0/Picture/2 description: The image shows the logo for Bio-Rad. The logo is in black and white, with the words "BIO+RAD" in a bold, sans-serif font. The plus sign is slightly raised above the baseline of the other letters. The logo is set against a black background. Bio-Rad Laboratories leronimo Roan vine. California 92618-2017 lenhone: (949) 598-1200 ## 510(k) Summary Submitter Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA (949)598-1285 Fax (949)598-1555 Contact Person Elizabeth Platt Date of Summary Preparation November 20, 1998 Device (Trade & Common Name) Liquichek Serum Volatiles Control Classification Name CFR 862.1660: Quality Control Materials (Assayed and Unassayed) Devices to Which Substantial Equivalence is Claimed Bio-Rad Liquichek Ethanol/Ammonia Control Bio-Rad Laboratories Irvine, California Statement of Intended Use Liquichek Serum Volatiles Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for BIO-RAD. The logo is in white text on a black background. The text is bold and sans-serif. Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200 ## Description of the Device Liquichek Serum Volatiles Control is prepared from human serum with added constituents of human origin, pure chemicals, and stabilizers. This product is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative. Statement of How Technological Characteristics Compare to Substantial Equivalence Device A table is provided below comparing the similarities between the Bio-Rad Liquichek Serum Volatiles Control and the devices to which substantial equivalence is claimed. | | Bio-Rad Liquichek<br>Ethanol/Ammonia Control | Bio-Rad Liquichek<br>Serum Volatiles Control | |--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended<br>Use | An assayed quality control<br>serum to monitor the<br>precision of laboratory<br>testing procedures for the<br>analytes listed in the<br>package insert. | An assayed quality control<br>serum to monitor the<br>precision of laboratory<br>testing procedures for the<br>analytes listed in the<br>package insert. | | Form | Liquid | Liquid | | Matrix | Bovine Serum | Human Serum | | Storage | 2-8°C | 2-8°C | | Analytes | Ammonia, Ethanol | Acetone, Ethanol, Ethylene<br>Glycol, Isopropanol,<br>Methanol | | Open Vial<br>Claim | 20 Days at 2-8°C | 10 Days at 2-8°C | {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles facing to the right. DEC 1 4 1998 Ms. Elizabeth Platt Requlatory Affairs Supervisor Bio-Rad Laboratories Diaqnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 K984225 Re: Liquichek Serum Volatiles Control Trade Name: Requlatory Class: I Product Code: JJY Dated: November 24, 1998 November 25, 1998 Received: Dear Ms. Platt: 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 Requlations, 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 Requlation (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. {3}------------------------------------------------ Page 2 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 requlation (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 qeneral 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/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 Radioloqical Health Enclosure {4}------------------------------------------------ Page 1 of 1 510(k) Number: _______________________________________________________________________________________________________________________________________________________________ Device Name: Liquichek Serum Volatiles Control Indications for Use: Liquichek Serum Volatiles Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. ## (PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (Concurrence of CDRH, Office of Device Evaluation) | Prescription Use | | |------------------|-------------------------| | | OR Over-The Counter Use | (Division Sign-Off) 31 Division of Clinical Laboratory Devices 510(k) Number