LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEVEL S2E, MODEL 439

K022707 · Bio-Rad · DIF · Aug 22, 2002 · Clinical Toxicology

Device Facts

• Record ID: K022707
• Device Name: LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEVEL S2E, MODEL 439
• Applicant: Bio-Rad
• Product Code: DIF · Clinical Toxicology
• Decision Date: Aug 22, 2002
• 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 enzyme immunoassay (EIA) screening procedures.

Device Story

Liquichek™ Urine Toxicology Control Levels S1E and S2E is a human urine-based quality control material containing drugs, drug metabolites, preservatives, and stabilizers. It is provided in liquid form for use in clinical laboratories to monitor the performance of enzyme immunoassay (EIA) screening procedures for toxicology. The control is available in two levels: Level S1E (concentrations 20-25% below EIA cutoff) and Level S2E (concentrations 20-25% above EIA cutoff). Laboratory personnel use the control to verify the accuracy and precision of screening assays. By comparing observed results against expected values, clinicians ensure the reliability of patient toxicology screening results, aiding in the detection of drugs of abuse.

Clinical Evidence

Bench testing only. Stability studies were performed to validate open vial stability (30 days at 2-8°C) and shelf life (2 years at 2-8°C). No clinical data was required or provided.

Technological Characteristics

Matrix: Human urine with added animal-derived constituents, drugs, metabolites, preservatives, and stabilizers. Form: Liquid. Storage: 2-8°C. Analytes: Methamphetamine, Secobarbital, Lormetazepam, THC, Benzoylecgonine, Ethanol, LSD, Methadone, Methaqualone, Morphine, Phencyclidine, Propoxyphene, Nortriptyline, Creatinine, pH, and Specific Gravity.

Indications for Use

Indicated for use as a quality control material in clinical laboratories to monitor the performance of urine toxicology enzyme immunoassay (EIA) screening procedures.

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 1M Urine Toxicology Control Levels S1 and S2 (K991558)

Submission Summary (Full Text)

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Page 1 of 3

K022767

Summary of Safety and Effectiveness Liquichek™ Urine Toxicology Control Levels S1E and S2E

### 1.0 Submitter

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

# Contact Person

Elizabeth Platt RA/QA Manager Telephone: [phone]

# Date of Summary Preparation

August 2, 2002

### 2.0 Device Identification

| Product Trade Name: | Liquichek™ Urine Toxicology Control Levels S1E and<br>S2E |
|---------------------|-----------------------------------------------------------|
| Common Name: | Drug Mixture Controls |
| Classifications: | Class I |
| Product Code: | 91DIF |
| Regulation Number: | CFR 862.3280 |

### 3.0 Device to Which Substantial Equivalence is Claimed

Liquichek 1M Urine Toxicology Control Levels S1 and S2 Bio-Rad Laboratories Irvine, California

Docket Numbers: K991558

#### 4.0 Description of Device

Liquichek™ Urine Toxicology Control Levels S1E and S2E is prepared from human urine with added constituents of animal origin, drugs, drug metabolites, preservatives, and stabilizers. The control is provided in liquid form for convenience.

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## Statement of Intended Use 5.0

ﺮ ﺍﻟﻤﺮﺍﺟﻊ

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

The new Liquichek™ Urine Toxicology Control claims substantial equivalence to the Liquichek™ Urine Toxicology Controls currently in commercial distribution (K991558).

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

| Characteristics | Bio Rad<br>Liquichek™ Urine Toxicology Control,<br>Levels S1E and S2E<br>(New Device) | Bio Rad<br>Liquichek™ Urine Toxicology Control,<br>Levels S1 ans S2<br>(Predicate Device) |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Form | Liquid | Liquid |
| Matrix | Human urine | Human urine |
| Storage<br>(Unopened) | 2-8° C<br>until expiration date | 2-8° C<br>until expiration date |
| Open Vial<br>Claim | 2-8° C for 30 days | 2-8° C for 30 days |
| Differences | | |
| Intended Use | A quality control urine to monitor the<br>performance of laboratory urine<br>toxicology enzyme immunoassay<br>(EIA) screening procedures. | A quality control urine to monitor the<br>performance of laboratory urine<br>toxicology screening procedures. |
| Levels | Level S1E = Drugs and drug<br>metabolites added during<br>manufacture at concentrations<br>20-25% <b>below</b> enzyme<br>immunoassay cutoff levels.<br>Level S2E = Drugs and drug<br>metabolites added at concentrations<br>20-25% <b>above</b> enzyme<br>immunoassay cutoff levels. | Level S1 = Drugs and drug<br>metabolites added at concentrations<br>20-25% <b>below</b> immunoassay cutoff<br>levels.<br>Level S2 = Drugs and drug<br>metabolites added at concentrations<br>20-25% <b>above</b> immunoassay cutoff<br>levels. |

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| Characteristics | Bio Rad<br>Liquichek™ Urine Toxicology Control,<br>Levels S1E and S2E<br>(New Device) | Bio Rad<br>Liquichek™ Urine Toxicology Control,<br>Levels S1 and S2<br>(Predicate Device) |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Differences | | |
| Claimed<br>Analytes | Methamphetamine, Secobarbital,<br>Lormetazepam, Tetrahydrocannabinol<br>(THC), Benzoylecgonine, Ethanol,<br>Lysergic Acid Diethylamide (LSD),<br>Methadone, Methaqualone, Morphine<br>(Free), Phencyclidine, Propoxyphene,<br>Nortriptyline and addition of Creatinine,<br>pH, Specific Gravity. | Amphetamine, Secobarbital,<br>Nordiazepam, Tetrahydrocannabinol<br>(THC), Benzoylecgonine, Ethanol,<br>Lysergic Acid Diethylamide (LSD),<br>Methadone, Methaqualone, Morphine<br>(Free), Phencyclidine, Propoxyphene,<br>Nortriptyline. |

# 2.0 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:

- 2.1 Open vial: Once the control is opened, all analytes will be stable for 30 days when stored tightly capped at 2-8°C.
- 2.2 Shelf Life: 2 years when stored unopened at 2-8°C.

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.

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AUG 2 2 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k022707

> Trade/Device Name: Liquichek™ Urine Toxicology Control Levels S1E and S2E Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DIF Dated: August 2, 2002 Received: August 14, 2002

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. Iisting 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/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

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510 (k) Number (if known):____________________________________________________________________________________________________________________________________________________

Device Name: Liquichek™ Urine Toxicology Control Levels S1E and S2E

Indications for Use:

Liquichek™ Urine Toxicology Control Levels S1E and S2E is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology enzyme immunoassay (EIA) screening procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription use Over-the Counter or use

Carol C. Benson (for Jean Cooper, DUm