LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S3

{0}------------------------------------------------ K971691 Image /page/0/Picture/1 description: The image shows the logo for BIO-RAD. The logo is white text on a black rounded rectangle. The text is in all caps and bolded. **Bio-Rad** **Laboratories** ECS Division 3726 E. Miraloma Avenue naheim. CA 92806 Telephone (714) 630-6400 Toll Free (800) 854-6737 ## 510(k) Summary MAY 30 1997 Submitter Bio-Rad Laboratories, ECS Division 3726 E. Miraloma Avenue Anaheim, CA 92806 (714)630-6400 Fax (714)666-1383 Contact Person Elizabeth Platt Date of Summary Preparation February 7, 1997 Device (Trade & Common Name) Liquichek Urine Toxicology Control Classification Name Class I, CFR 862.3280: Drug Mixture Control 91DIF Devices to Which Substantial Equivalence is Claimed Liguid Drugs of Abuse Controls Medical Analysis Systems, Camarillo, California K903430 Statement of Intended Use Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology screening procedures. {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. ratories ECS Division 3726 E. Miraloma Avenue Anaheim. CA 92806 Telephone (714) 630-6400 Toll Free (800) 854-6737 ## Description of the Device Liquichek Urine Toxicology Control is prepared from human urine with added drugs, drug metabolites, preservatives and stabilizers. The control 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 Urine Toxicology Control and the devices to which substantial equivalence is claimed. | | Bio-Rad Liquichek<br>Urine Toxicology Control | Liquid Drugs of Abuse Controls<br>Medical Analysis Systems | |-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended<br>Use | A quality control urine to monitor<br>the performance of laboratory<br>urine toxicology screening<br>procedures. | A consistent test sample of known<br>concentration for monitoring assay<br>conditions in quantitative and<br>qualitative analysis of patient urine<br>specimens for drug and drug<br>metabolites. | | Levels | Level S1 = Drugs added at<br>concentrations<br>20-25% below<br>immunoassay cutoff<br>Level S2 = Drugs added at<br>concentrations<br>20-25% above<br>immunoassay cutoff<br>Level S3 = Elevated<br>immunoassay | Level 2 = 20-25% below<br>immunoassay cutoff<br>Level 3 = 20-25% above<br>immunoassay cutoff<br>Level 4 = Elevated<br>immunoassay | | Form | Liquid | Liquid | | Matrix | Human Urine | Human Urine | | Storage | 2-8°C | 2-8°C | | Open<br>Vial<br>Claim | 30 Days at 2-8°C | 30 Days at 2-8°C | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle. MAY 30 1997 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Elizabeth Platt Staff Regulatory Affairs Representative Bio-Rad Laboratories ... . ..... 3726 E. Miraloma Avenue Anaheim, California 92806 Re: K971691 Liquichek Urine Toxicology Control - Level S1, S2, S3 Requlatory Class: I Product Code: DIF Dated: April 16, 1997 Received: May 7, 1997 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 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 The general controls provisions of the Act 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. ਕ 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, 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 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 w 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Steven Litman 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 Urine Toxicology Control Indications for Use: 12 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 Liquichek Urine Toxicology Control is intended for use as a quality control urine Liquichek Unite Toxicology Oonliror in interactive concology screening procedures. to monitor the performance of laboratory urine toxicology screening procedures. (PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (Concurrence of CDRH, Office of Device Evaluation) ี เวลนทาง (x)015 કરત , vid ୍ଦାପ) Over-The Counter Use __ OR Prescription Use 0 (Division 3 -1749 Division y ారు ఒ 45 510(k) Number