LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES)

K033404 · Bio-Rad · DIF · Dec 12, 2003 · Clinical Toxicology

Device Facts

• Record ID: K033404
• Device Name: LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES)
• Applicant: Bio-Rad
• Product Code: DIF · Clinical Toxicology
• Decision Date: Dec 12, 2003
• 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 a 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 prepared from human urine; supplemented with drugs of abuse, metabolites, preservatives, and stabilizers. Used in clinical laboratories by laboratory personnel to monitor the performance of urine toxicology confirmatory procedures. The control provides a known reference point to verify the accuracy and precision of analytical testing methods. By comparing the laboratory's test results for the control against expected values, clinicians and laboratory staff ensure the reliability of patient test results, thereby supporting accurate clinical decision-making regarding drug screening and confirmation.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, specifically stability studies demonstrating that all analytes remain stable for 30 days when stored at 2 to 8°C and a shelf life of 3 years at 2 to 8°C.

Technological Characteristics

Liquid-form human urine-based control material. Contains drugs of abuse, metabolites, preservatives, and stabilizers. Value assignment via gas chromatography. Stability testing conducted at 2-8 °C and -20 °C. No electronic, software, or energy-based components.

Indications for Use

Indicated for use as a quality control material in laboratory urine toxicology confirmatory procedures. No specific patient population, age, or disease state is applicable as this is an in vitro diagnostic control material.

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 Levels C1, C2, C3, C4 (K021384)

Submission Summary (Full Text)

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DEC 12 2003

K033404

# Summary of Safety and Effectiveness Liquichek Urine Toxicology Control (Confirmatory Series)

### 1.0 Submitter

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

## Contact Person

Maria Zeballos Requlatory Affairs Specialist [phone] Telephone:

## Date of Summary Preparation

October 22, 2003

### 2.0 Device Identification

Product Trade Name:

Liquichek Urine Toxicology Control

- Liquichek Urine Toxicology Control Level C1 ם
- Liquichek Urine Toxicology Control Level C2 0
- Liquichek Urine Toxicology Control Level C3
- Liquichek Urine Toxicology Control Level C4 0
- Liquichek Urine Toxicology Control Level C2 Low Opiate ם
- Liquichek Urine Toxicology Control Level C3 Low Opiate ට

| 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 Levels C1, C2, C3 and C4 Bio-Rad Laboratories Irvine, California Docket Number: K021384

## Description of Device 4.0

Liquichek Urine Toxicology Controls are prepared from human urine with added drugs of abuse, 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 a 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

Control contains 3.4-Methylenedioxy-Toxicology Liquichek Urine The new methamphetamine (MDMA), 3,4-Methylenedioxyamphetamine (MDA) and 3.4methylenedioxy-N-ethylamphetamine (MDEA) in levels C2, C3 and C4 , and the Mich our entry to Liquichek Urine Toxicology Control (K021384) to which substantial equivalence is claimed does not contain these analytes.

| Characteristics | Bio-Rad Liquichek Urine Toxicology Control<br>(Confirmatory Series)<br>(New Device) | Bio-Rad Liquichek Urine Toxicology Control<br>Levels C1, C2, C3 and C4<br>(Predicate Device K021384) |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures. | Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures. |
| Form | Liquid | Liquid |
| Matrix | Urine | Urine |
| Storage (Unopened) | 2 to 8°C until expiration date | 2 to 8°C until expiration date |
| Open Vial | 30 days at 2 to 8°C | 30 days at 2 to 8°C |
| Differences | | |
| Drugs | Same as the predicate device with the addition in Levels C2, C3 and C4 of:<br><br>3,4-Methylenedioxymethamphetamine (MDMA),<br>3,4-Methylenedioxyamphetamine (MDA) and<br>3,4-Methylenedioxy-N-ethylamphetamine (MDEA) | 11-Nor-Δ-9-THC-9-COOH, Alpha-Hydroxyalprazolam,<br>Amobarbital, d-Amphetamine, Benzoylecgonine,<br>Butalbital, Codeine, Ethanol, Lysergic Acid<br>Diethylamide (LSD), d-Methamphetamine,<br>Methadone, Methaqualone, Morphine-3-β-D-<br>Glucuronide, Nordiazepam, Norpropoxyphene,<br>Pentobarbital, Phencyclidine, Phenobarbital,<br>Secobarbital<br><br>Does not contain:<br>3,4-Methylenedioxymethamphetamine (MDMA),<br>3,4-Methylenedioxyamphetamine (MDA) and<br>3,4-Methylenedioxy-N-ethylamphetamine (MDEA) |
| Label Warnings | Does not require hazard symbols | Requires hazard symbols |

Table 1. Similarities and Differences between new and predicate device.

#### 7.0 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:

- Open vial: All analytes will be stable for 30 days when stored tightly capped at 2 to 8°C. 7.1
- Shelf Life: 3 Years at 2 to 8°C 7.2
- Real time studies will be ongoing to support the shelf life of this product. 7.3

All supporting data is retained on file at Bio-Rad Laboratories.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Maria Zeballos, RAC Regulatory Affairs Specialist Bio-Rad Laboratories, QSD Diagnostics Group 9500 Jeronimo Road Irvine, CA 92618-2017

Re: k033404

Trade/Device Name: Liquichek Urine Toxicology Control Level C1 Liquichek Urine Toxicology Control Level C2 Liquichek Urine Toxicology Control Level C3 Liquichek Urine Toxicology Control Level C4 Liquichek Urine Toxicology Control Level C2 Low Opiate Liquichek Urine Toxicology Control Level C3 Low Opiate Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DIF Dated: October 22, 2003 Received: October 29, 2003

DEC 1 2 2003

Dear Ms. Zeballos:

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 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 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 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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## Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda_gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510 (k) Number (if known): K033 404

Device Name:

Liquichek Urine Toxicology Confirmatory Series Control

- Liquichek Urine Toxicology Control Level C1 ロ
- Liquichek Urine Toxicology Control Level C2 0
- Liquichek Urine Toxicology Control Level C3 0
- Liquichek Urine Toxicology Control Level C4 D
- Liquichek Urine Toxicology Control Level C2 Low Opiate 0
- Liquichek Urine Toxicology Control Level C3 Low Opiate ப

Indications for Use:

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

(PLEASE DO NOT WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use ***_*****_ or Over-the Counter use**

Albert
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k033404