LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)

K050682 · Bio-Rad Laboratories, Inc. · DIF · Apr 29, 2005 · Clinical Toxicology

Device Facts

• Record ID: K050682
• Device Name: LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: DIF · Clinical Toxicology
• Decision Date: Apr 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Intended Use

Liquichek Urine Toxicology Control is intended for use as quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures.

Device Story

Liquichek Urine Toxicology Control is a liquid-form quality control material derived from human urine; supplemented with drugs of abuse, metabolites, preservatives, and stabilizers. It serves as a reference to monitor the performance of laboratory urine toxicology confirmatory procedures. The device is used by laboratory personnel in clinical settings. It contains a mixture of analytes including amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, ethanol, LSD, methadone, methaqualone, opiates, phencyclidine, propoxyphene, creatinine, and MDMA/MDA/MDEA. Reference values are established via gravimetric methods and GC analysis. The product is tested for HBsAg, HCV, and HIV-1/HIV-2. It provides laboratories with a standardized sample to verify the accuracy and reliability of their toxicology testing workflows.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (open and closed vial) were performed using GC/MS to verify recovery within +/- 10% of Tzero values. Accelerated stability testing predicted a 4-year shelf life.

Technological Characteristics

Liquid-form human urine matrix containing drugs of abuse, metabolites, preservatives, and stabilizers. Stored at 2-8°C. No software or electronic components.

Indications for Use

Indicated for use as a quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures in clinical laboratory settings.

Regulatory Classification

Identification

A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

Predicate Devices

• Liquichek Urine Toxicology Control (K033404)

Submission Summary (Full Text)

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K050682

## APR 2 9 2005

Page 1 of 2

Summary of Safety and Effectiveness Liquichek Urine Toxicology Control (Level C1)

#### 1.0 Submitter

Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 [phone] Telephone: [phone] Fax:

### Contact Person

Suzanne S. Parsons Regulatory Affairs Specialist Telephone: [phone]

## Date of Summary Preparation

March 9, 2005

#### 2.0 Device Identification

Product Trade Name:

Liquichek Urine Toxicology Control

| Common Name: | Drug Mixture Control |
|--------------------|----------------------|
| Classifications: | Class I |
| Product Code: | DIF |
| Regulation Number: | 21 CFR 862.3280 |

#### Device to Which Substantial Equivalence is Claimed 3.0

Liquichek Urine Toxicology Control Bio-Rad Laboratories Irvine, California

Docket Number: K033404

#### 4.0 Description of Device

Liquichek Urine Toxicology Control is 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.

#### Statement of Intended Use 5.0

Liquichek Urine Toxicology Control is intended for use as quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures.

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### Comparison of the new device with the Predicate Device 6.0

The new Liquichek Urine Toxicology Control (Level C1) claims substantial equivalence The now Eiquichek Urine Toxicology Control (Level C1) currently in commercial distribution (K033404). The new Liquichek Urine Toxicology Control contains MDMA, MDA and MDEA and the predicate device does not.

| Characteristics | Bio-Rad Liquichek Urine Toxicology Control<br>(Level C1)<br>(Predicate Device K033404) | Bio-Rad Liquichek Urine Toxicology Control<br>(Level C1)<br>(New Device) |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Similarities | |
| Intended Use | Liquichek Urine Toxicology Control is intended for use as quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures. | Liquichek Urine Toxicology Control is intended for use as quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures. |
| 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 2-8°C | 30 days at 2-8°C |
| | Differences | |
| Drugs | Contains:<br>d-Amphetamine<br>d-Methamphetamine<br>Secobarbital<br>Amobarbital<br>Butalbital<br>Pentobarbital<br>Phenobarbital<br>Nordiazepam<br>a-hydroxyalprazolam<br>11-Nor-Δ-9-THC-9-COOH<br>Benzoylecgonine<br>Ethanol<br>LSD<br>Methadone<br>Methaqualone<br>Morphine-3-β-D-glucuronide<br>Codeine<br>Phencyclidine<br>Norpropoxyphene<br>Creatinine<br>Specific Gravity<br>pH<br>Does not contain:<br>MDMA<br>MDA | Contains:<br>d-Amphetamine<br>d-Methamphetamine<br>Secobarbital<br>Amobarbital<br>Butalbital<br>Pentobarbital<br>Phenobarbital<br>Nordiazepam<br>α -hydroxyalprazolam<br>11-Nor-Δ-9-THC-9-COOH<br>Benzoylecgonine<br>Ethanol<br>LSD<br>Methadone<br>Methaqualone<br>Morphine-3-β-D-glucuronide<br>Codeine<br>Phencyclidine<br>Norpropoxyphene<br>Creatinine<br>Specific Gravity<br>pH<br>MDMA<br>MDA<br>MDEA |

| 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 Urine Toxicology Control (Level C1). Product claims are as follows:

- 30 days at 2-8°C. 7.1 Open vial:
- Three years stored at 2-8°C 7.2 Shelf Life:

Real time studies will be ongoing to support the shelf life of this product.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 2 9 2005

Ms. Suzanne S. Parsons Regulatory Affairs Specialist Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine CA 92618-2017

k050682 Re:

Trade/Device Name: Liquichek Urine Toxicology Control ( Level C1) Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DIF Dated: March 10, 2005 Received: March 16, 2005

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 for ass sured in the 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 r rease of acress a determination that your device complies with other requirements of the Act that 1197 has 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ough finding of substantial equivalence of your device to a legally premarket notification - The sults in a classification 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 actuatising of your device, please contact the Office of In or questions on the promotion and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I bu may other belief general mensactional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sean M. Cooper MS, DUM

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

| Device Name: | Liquichek Urine Toxicology Control (Level C1) |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use: | Liquichek Urine Toxicology Control is intended for use as quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures. |

Prescription Use __ × (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)

Albert Ca

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(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K050682