LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)

K033924 · Bio-Rad Laboratories, Inc. · DIF · Feb 3, 2004 · Clinical Toxicology

Device Facts

• Record ID: K033924
• Device Name: LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: DIF · Clinical Toxicology
• Decision Date: Feb 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Intended Use

The product is intended for use as a quality control urine to monitor the performance of urine toxicology screening procedures. The device is for in vitro diagnostic use. The device is for prescription use.

Device Story

Liquichek Urine Toxicology Control is a liquid-form quality control material derived from human urine; supplemented with drugs of abuse, drug metabolites, preservatives, and animal-derived constituents. Used in clinical laboratories to monitor the performance of urine toxicology screening procedures and enzyme immunoassays (EIA). Healthcare providers use the control to verify the accuracy and reliability of their screening assays; ensuring consistent performance of diagnostic tests. The device provides a known reference point for laboratory personnel to validate test results, thereby supporting clinical decision-making regarding patient drug screening.

Clinical Evidence

No clinical data. Bench testing only. Stability studies performed using GC/MS to verify concentrations and monitor drift (acceptance criteria: 10% drift from time zero).

Technological Characteristics

Liquid-form human urine matrix; contains drugs of abuse, metabolites, preservatives (antibiotic cocktail), and animal-derived constituents. Storage 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 urine toxicology screening 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 Levels S1, S2, and S3 (K021411)

Submission Summary (Full Text)

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K033924

Page 1 of 2

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

#### 1.0 Submitter

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

# Contact Person

Maria Zeballos Regulatory Affairs Specialist Telephone: [phone]

### Date of Summary Preparation

December 16, 2003

#### 2.0 Device Identification

Product Trade Name:

Liquichek Urine Toxicology Control (Screen Series)

- 0 Liquichek Urine Toxicology S1 Control
- Liquichek Urine Toxicology S2 Control ப
- Liquichek Urine Toxicology S3 Control 0
- 0 Liquichek Urine Toxicology S1 Low Opiate Control
- Liquichek Urine Toxicology S2 Low Opiate Control 0
- 0 Liquichek Urine Toxicology S1E Control
- Liquichek Urine Toxicology S2E Control
- 0 Liquichek Urine Toxicology S1E Low Opiate Control
- 0 Liquichek Urine Toxicology S2E Low Opiate Control

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

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

Liquichek Urine Toxicology Control Bio-Rad Laboratories Irvine, California

Docket Number: K021411

#### 4.0 Description of Device

Liquichek 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.

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#### 5.0 Statement of Intended Use

Liquichek Urine Toxicology Controls are intended for use as quality controls urine to monitor the performance of laboratory urine toxicology screening* procedures. *[S1E/S2E: enzyme immunoassay (EIA)]

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

The new Liquichek Urine Toxicology Controls claim substantial equivalence to the Liquichek Urine Toxicology Controls currently in commercial distribution (K021411).

| Characteristics | Bio-Rad Liquichek Urine Toxicology Control<br>(Screen Series)<br>(New Device) | Bio-Rad Liquichek Urine Toxicology Control<br>(Screen Series)<br>(Predicate Device K021411) |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Liquichek Urine Toxicology Control is intended for use<br>as a quality control urine to monitor the performance<br>of laboratory urine toxicology screening procedures. | Liquichek Urine Toxicology Control is intended for use<br>as a quality control urine to monitor the performance<br>of laboratory urine toxicology screening 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 |
| Drugs | Same as the predicate device | 11-Nor-Δ-9-THC-9-COOH, Amphetamines, d-Amphetamine, Barbiturates, Benzodiazepines, Benzoylecgonine, Cannabinoids, Cocaine, Ethanol, Lysergic Acid Diethylamide (LSD), Methadone, Methaqualone, Morphine (Free), Nordiazepam, Nortriptyline, Opiates, Phencyclidine, Propoxyphene, Secobarbital, Tricyclic Antidepressants |
| Differences | | |
| Levels | S1, S2, S3, S1E, S2E, S1 Low Opiate and S2 Low<br>Opiate. Includes new levels added to the product<br>line: S1E Low Opiate and S2E Low Opiate | S1, S2, S3, S1E, S2E, S1 Low Opiate and S2 Low<br>Opiate. Does not include levels:<br>S1E Low Opiate and S2E Low Opiate |
| Preservatives &<br>Label Warnings | Antibiotic Preservative cocktail | Contains 0.1% Sodium Azide<br>Requires hazard symbols |

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

#### 7.0 Summary of Performance Data

Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek Urine Toxicology Control (Screen Series). Product claims are as follows:

- Open vial: All analytes are stable for 30 days when stored tightly capped at 2-8°C. 7.1
- 7.2 Shelf Life:
- ם S1E, S2E, S1E Low Opiate, S2E Low Opiate: Two years stored at 2-8 °C ם S1, S2, S3, S1 Low Opiate, S2 Low Opiate: Three years stored at 2-8 °C
- 7.3 Real time studies will be ongoing to support the shelf life of this product.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB - 3 2004

Ms. Elizabeth Platt Regulatory Affairs Manager/Quality Assurance Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-2017

Re: k033924

> Trade/Device Name: Liquichek Urine Toxicology Control Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DIF Dated: December 16, 2003 Received: December 18, 2003

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 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 (OS) 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,

Jean M. Cooper, MS, DVM.

Yean 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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KO33924 510 (k) Number (if known):

Device Name:

# Liquichek Urine Toxicology Control

- Liquichek Urine Toxicology S1 Control 0
- Liquichek Urine Toxicology S2 Control 0
- Liquichek Urine Toxicology S3 Control 0
- Liquichek Urine Toxicology S1 Low Opiate Control ប្រ
- Liquichek Urine Toxicology S2 Low Opiate Control D
- Liquichek Urine Toxicology S1E Control ロ
- Liquichek Urine Toxicology S2E Control
- Liquichek Urine Toxicology S1E Low Opiate Control 0
- ロ Liquichek Urine Toxicology S2E Low Opiate Control

Indications for Use:

# Levels S1, S2, S3, S1 Low Opiate, and S2 Low Opiate

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

# Levels S1E, S2E, S1E Low Opiate and S2E Low Opiate

Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology enzyme immunoassay (EIA) screening procedures.

Aberto Salm

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

(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