LIQUICHEK TDM CONTROL

{0}------------------------------------------------ ## Summary of Safety and Effectiveness Liquichek™ TDM 1, 2, 3 K0127411 /12/01 #### Submitter 1.0 Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1555 Fax: ## Contact Person Maria Zeballos Regulatory Affairs Specialist (949) 598-1367 Telephone: ### Date of Summary Preparation August 15, 2001 #### Device Identification 2.0 | Product Name: | Liquichek™ TDM 1, 2, 3 | |---------------|------------------------| |---------------|------------------------| Drug Mixture Control Materials Common Name: Dif Classifications: Class | Product Code: Regulation Number: 21 CFR 862.3280 #### Device to Which Substantial Equivalence is Claimed 3.0 Original 510(k) Name: Kit Ciba Corning L-TDM Control I, III Current Name: Liquichek™ TDM 1, 2, 3 Bio-Rad Laboratories Irvine, California Docket Number: K893682 #### Description of Device 4.0 Liquichek™ TDM is prepared from human serum, with added constituents of nonhuman protein, drugs and preservatives. The control is provided in liquid form for convenience. #### 5.0 Statement of Intended Use Liquichek™ TDM is intended for use as an assayed quality control serum to monitor the precision of laboratory procedures and other analytes listed in the package insert. {1}------------------------------------------------ ### Comparison of the new device with the Predicate Device 6.0 The new Liquichek™ TDM 1, 2, 3 claims substantial equivalence to the Liquichek™ The now Liquicher in commercial distribution (K893682). The new Liquichek™ TDM 1, 2, 3 contains preservatives and the current product does not. | Characteristics | Bio Rad<br>LiquichekTM TDM 1, 2, 3<br>(New Device) | Bio Rad<br>LiquichekTM TDM 1, 2, 3<br>(Predicate Device) | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Liquichek TDM 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. | Liquichek TDM 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. | | Form | Liquid | Liquid | | Matrix | Human serum based | Human serum based | | Storage<br>(Unopened Frozen) | -20°C or colder<br>until expiration date | -20°C or colder<br>until expiration date | | Analytes | Same as Predicate (see insert) | Same as new device (see insert) | | Storage<br>(Unopened Thawed) | 2-8° C for 180 days<br>Exceptions:<br>Cortisol, Desipramine, T4 total and T3 free are stable for 30 days. | 2-8° C for 180 days<br>Exceptions:<br>Clonazepam, Cortisol, Desipramine, and free T4 are stable for 30 days. | | Open Vial Claim | 2-8° C for 30 days.<br>Exceptions:<br>T3 total and T3 free will be stable for 15 days and<br>Diazepam will be stable for 24 hours days. | 2-8° C for 30 days.<br>Exceptions:<br>T3 will be stable for 15 days and<br>Diazepam will be stable for 24 hours days. | | Preservatives | Preservatives are added | No preservatives or stabilizers were added | # Table 1. Similarities and Differences between new and predicate device. #### SUMMARY OF PERFORMANCE DATA 7.0 Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ TDM 1, 2, 3. Product claims are as follows: - 7.1 Open vial: Once the control is thawed and opened, all analytes will be stable for 30 days when stored tightly capped at 2-8°C, with the following exceptions: Ta total and T3 free will be stable for 15 days and Diazepam will be stable for 24 hours days. Avoid repeated freezing and thawing of the quality control material. {2}------------------------------------------------ - Closed Vial: When the control material is thawed and stored unopened at 2-8° C 7.2 all analytes will be stable for 180 days with the following exceptions: Cortisol, Desipramine, and T4 total and T3 free are stable for 30 days - Shelf Life: 36 months when stored at -20 °C or colder 7.3 Real time studies to support the shelf life of this product are available. All supporting data is retained on file at Bio-Rad Laboratories. {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread. SEP 1 2 2001 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Elizabeth Platt Regulatory Affairs Manager Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618 k012741 Re: · Trade/Device Name: Liquichek™ TDM 1, 2, 3 Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical Toxicology Control Material Regulatory Class: Class I, reserved Product Code: DIF Dated: August 15, 2001 Received: August 16, 2001 Dear Ms. Platt: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becatermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surve in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of they 2018 11:07 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 (OS) 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 1 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/cdrb/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 Radiological Health Enclosure {5}------------------------------------------------ 2 510 (k) Number (if known):____________________________________________________________________________________________________________________________________________________ Device Name: Liquichek™ TDM 1, 2, 3 Indications for Use: Liquichek TDM Is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes fisted in the package insert. (PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription use | <div> <img alt="Checkmark" src="prescription_use_check.png"/> </div> | or | Over-the Counter use | |------------------|----------------------------------------------------------------------|----|----------------------| |------------------|----------------------------------------------------------------------|----|----------------------|  (Division Sign-Off) Division of Clinical Laboratory Devices | 510(k) Number | K012741 | |---------------|---------| |---------------|---------|