LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK

{0}------------------------------------------------ K052053 Summary of Safety and Effectiveness Liquichek Qualitative Urine Toxicology Control #### 1.0 Submitter AUG 9 - 2005 Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1557 Fax: ## Contact Person Suzanne S. Parsons Regulatory Affairs Specialist (949) 598-1467 Telephone: ## Date of Summary Preparation July 25, 2005 #### Device Identification 2.0 | Product Trade Name: | Liquichek Qualitative Urine Toxicology Control | |---------------------|------------------------------------------------| | Common Name: | Drug Mixture Control Materials | | Classifications: | Class I | | Product Code: | DIF | 21 CFR 862.3280 Regulation Number: #### 3.0 Device to Which Substantial Equivalence is Claimed Liquichek Qualitative Urine Toxicology Control Bio-Rad Laboratories Irvine, California Docket Number: K033366 #### 4.0 Description of Device Liquichek Qualitative Urine Toxicology Controls are prepared from human urine with added drugs of abuse and metabolites of drugs of abuse, preservatives, stabilizers, and constituents of animal origin. The control is provided in liquid form for convenience. #### 5.0 Statement of Intended Use Liquichek Qualitative Urine Toxicology Control is intended for use as an assayed quality control urine to monitor the performance of laboratory procedures for qualitative urine toxicology. {1}------------------------------------------------ ### Comparison of the new device with the Predicate Device 6.0 The new Liquichek Qualitative Urine Toxicology Control contains Oxycodone, and the rre new Equilonek Qualitative Urine Toxicology Control (K033366) to which substantial equivalence is claimed, does not contain Oxycodone. | | Bio-Rad Liquichek Qualitative<br>Urine Toxicology Control<br>(New Device) | Bio-Rad Liquichek Qualitative<br>Urine Toxicology Control<br>(Predicate Device K001973) | |-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristics | | | | | Similarities | | | Intended Use | Liquichek Qualitative Urine Toxicology Control is<br>intended for use as an assayed quality control urine to<br>monitor the performance of laboratory procedures for<br>qualitative urine toxicology. | Liquichek Qualitative Urine Toxicology Control is<br>intended for use as an assayed quality control urine<br>to monitor the performance of laboratory procedures<br>for qualitative urine toxicology. | | Form | Liquid | Liquid | | Matrix | Urine | Urine | | Storage<br>(Unopened) | 2-8°C until expiration date | 2-8°C until expiration date | | Open Vial | 30 days at 2 to 8°C or 18 to 25°C | 30 days at 2 to 8°C or 18 to 25°C | | | Differences | | | Drugs | Same as the predicate device with addition of Oxycodone | Contain:<br>Amphetamines<br>Barbiturates<br>Benzodiazepines<br>Benzoylecgonine<br>Cannabinoids<br>Cocaine<br>d-Amphetamine<br>d-Methamphetamine<br>Ethanol<br>LSD<br>MDMA (Ecstasy)<br>Methadone<br>Methaqualone<br>Morphine (Free)<br>Nordiazepam<br>Nortriptyline<br>Opiates<br>Oxazepam<br>Phencyclidine<br>Propoxyphene<br>Secobarbital<br>Tricyclic Antidepressants (TCA) | | | | Do not contain:<br>Oxycodone | Table 1. Similarities and Differences between new and predicate device. ## 2.0 Statement of Supporting Data Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek Qualitative Urine Toxicology Control. Product claims are as follows: - 2.1 Open vial: All analytes will be stable for 30 days when stored tightly capped at 2 to 8°C or 18 to 25°C. {2}------------------------------------------------ ## 2.2 Shelf Life: 3 Years at 2 to 8°C - 2.3 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}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 9 - 2005 Ms. Suzanne S. Parsons Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA 92618-2017 k052053 Re: K032035 Trade/Device Name: Liquichek Qualitative Urine Toxicology Control Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical Toxicology control material Regulatory Class: Class I Product Code: DIF Dated: July 25, 2005 Received: July 29, 2005 Dear Ms. Platt: We have reviewed your Section 510(k) premarket notification of intent to market the idevice We have reviewed your Section 910(x) premained institution marketed in interstate referenced above and have uctchillied the devices noredicate devices marketed in interstate for use stated in the encrosury manative power manatical Device Amendments, or to commerce prior to May 28, 1976, the enactment date of the Federal Food Drug commerce prior to May 28, 1970, the charters and other of the Federal Food. Drug, devices that have been reclassified in accordance will of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approval of a presisions of the A and Cosment Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The Act. The Y ou may, inerelore, market the device, salgoer to inements for annual registration, listing of general controls provisions of the Act include requirements for annual regist general controls provisions of the fice labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (SCC above) into effici vitas major regulations affecting your device it may be subject to such additional controllar Ensing mix can be found in Title 21, Coue of I ederal rogging your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a buccession with other requirements of the Act that FDA has made a determination that your device complies with on your must that FDA has made a decemmanon and Jour Secreed by other Federal agencies. You must or any Federal statutes and regulations administer of the registration and listing (21 comply with an the Act 3 requirements intractly good manufacturing practice CFK Part 807), labeling (21 OF Releves (QS) regulation (21 CFR Part 820). {4}------------------------------------------------ Page 2 - This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your avence of your device of your device to a legally premarket notification. The FDA finding of substantial equivale vour premarked notification. The PDA Intaing of basistication for your device and thus, permits your device to proceed to the market. If you desire specific information about the application of labeling requirements to your device, If you desire specific information about the up from device, please contact the Office of In or questions on the promotion and advertising of your a takes and the mass not th of questions on the promotion and Safety at (301) 594-3084. Also, please note the Vitto Diagnostic Device Livananon and Sareer at (3) and Sales (21CFR Part 807.97). regulation entitled, "Misbranding by reference to premarket notifications the regulation entitled, "Misoranting by reicrenes we presponsibilities under the Act from the You may outain buller general mormations. Jour 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, Albert Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): K052053 y Device Name: Liquichek Qualitative Urine Toxicology Control Indications For Use: Liquichek Qualitative Urine Toxicology Control is intended for use Liquicher Quality control urine to monitor the performance of as an accry procedures for qualitative urine toxicology. Prescription Use_ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) PAC vision Sign-Off) Sion of Clinical Laboratory Devices 510(k) Number Page 1 of