LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467

{0}------------------------------------------------ Bio-Rad Laboratories Premarket Notification Section 510(k) Liquichek™ Urine Toxicology Control Levels S1 Low Opiate and S2 Low Opia Summary of Safety and Effectiveness K021414 Page 1 of 3 Summary of Safety and Effectiveness Liquichek™ Urine Toxicology Control Levels S1 Low Opiate and S2 Low Opiate #### 1.0 Submitter Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: Fax: (949) 598-1555 # Contact Person Ofelia Cachola Requlatory Affairs Specialist Telephone: (949) 598-1287 ### Date of Summary Preparation May 1, 2002 #### 2.0 Device Identification | Product Trade Name: | Liquichek™ Urine Toxicology Control Levels S1 Low<br>Opiate and S2 Low Opiate | |---------------------|-------------------------------------------------------------------------------| | Common Name: | Drug Mixture Controls | | Classifications: | Class I | | Product Code: | DIF | | Regulation Number: | 21 CFR 862.3280 | #### 3.0 Device to Which Substantial Equivalence is Claimed Liquichek 100 Urine Toxicology Control Bio-Rad Laboratories Irvine, California Docket Numbers: K992812 and K992809 #### 4.0 Description of Device Liquichek™ Urine Toxicology Control Levels S1 Low Opiate and S2 Low Opiate are prepared from human urine with added constituents of animal origin, drugs, drug metabolites, preservatives, and stabilizers. The control is provided in liquid form for convenience. {1}------------------------------------------------ Bio-Rad Laboratories Premarket Notification Section 510(k) for Liquichek Urine Toxicology Control Levels S1 Low Opiate and S2 Low Opiate Summary of Safety and Effectiveness #### Statement of Intended Use 4. ﺍ Liquichek™ Urine Toxicology Control is intended for use as quality control urine to monitor the performance of laboratory urine toxicology screening procedures. #### Comparison of the new device with the Predicate Device 5.0 The new Liquichek™ Urine Toxicology Control claims substantial equivalence to the Liquichek™ Urine Toxicology Control currently in commercial distribution (K992812 and K992809). The new Liquichek™ Urine Toxicology Control has additional claims for Creatinine, pH, and Specific Gravity and the current product does not. | Characteristics | Bio Rad<br>Liquichek™ Urine Toxicology<br>Control<br>(New Device) | Bio Rad<br>Liquichek™ Urine Toxicology<br>Control<br>(Predicate Device) | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Similarities | | | | Intended Use | Liquichek™ Urine Toxicology<br>Control is intended for use as<br>quality control urine to monitor the<br>performance of laboratory urine<br>toxicology screening procedures. | Liquichek™ Urine Toxicology<br>Control is intended for use as a<br>quality control urine to monitor the<br>performance of laboratory urine<br>toxicology screening procedures. | | Levels | Same as predicate device. | Level S1Low Opiate = Drugs<br>added at concentrations<br>20-25% <b>below</b> immunoassay<br>cutoffs.<br>Level S2 Low Opiate = Drugs<br>added at concentrations<br>20-25% <b>above</b> immunoassay<br>cutoffs. | | Form | Liquid | Liquid | | Matrix | Human urine | Human urine | | Storage<br>(Unopened) | 2-8° C<br>until expiration date | 2-8° C<br>until expiration date | | Open Vial Claim | 2-8° C for 30 days. | 2-8° C for 30 days. | | Differences | | | | Analytes | Same analytes as the predicate<br>device with the additional claims<br>for Creatinine, pH and Specific | D-Amphetamine, Secobarbital,<br>Nordiazepam, 11-Nor-Δ-9-THC-9-<br>COOH), Benzoylecgonine. | Table 1. Similarities and Differences between new and predicate device. {2}------------------------------------------------ Bio-Rad Laboratories Premarket Notification Section 510(k) for Liquichek Urine Toxicology Control Levels S1 Low Opiate and S2 Low Opiate Summary of Safety and Effectiveness | Gravity. | Ethanol, Lysergic Acid Diethylamide (LSD), Methadone, Methaqualone, Morphine (Free), | |----------|----------------------------------------------------------------------------------------| |----------|----------------------------------------------------------------------------------------| ## 2.0 Statement of Supporting Data Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Urine Toxicology Control. Product claims are as follows: Phencyclidine, Propoxyphene, Nortriptyline. - 2.1 Open vial: Once the control is opened, all analytes will be stable for 30 days when stored tightly capped at 2-8°C. - 2.2 Shelf Life: 24 months when stored at 2-8°C Real time studies will be ongoing to support the shelf life of this product. All supporting data is retained on file at Bio-Rad Laboratories. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 # MAY 2 9 2002 Ms. Elizabeth Platt Regulatory Affairs Manager Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, California 92618-2017 k021414 Re: Trade/Device Name: Liquichek™ Urine Toxicology Control Levels S1 Low Opiate and S2 Low Opiate Regulation Number: 21 CFR § 862.3280 Regulation Name: Clinical Toxicology Control Material Regulatory Class: I Product Code: DIF Dated: May 1, 2002 Received: May 3, 2002 Dear Ms. Platt: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ 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 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer 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 Sutman 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 {5}------------------------------------------------ 021414 510 (k) Number (if known): Device Name: Liquichek™ Urine Toxicology Control Levels S1 Low Opiate and S2 Low Opiate Indications for Use: A quality control urine to monitor the performance of laboratory urine toxicology screening procedures. Sean Cooper (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number. (PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription use or Over-the Counter