LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469

K021415 · Bio-Rad · DIF · May 29, 2002 · Clinical Toxicology

Device Facts

• Record ID: K021415
• Device Name: LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469
• Applicant: Bio-Rad
• Product Code: DIF · Clinical Toxicology
• Decision Date: May 29, 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 quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures.

Device Story

Liquichek™ Urine Toxicology Control Levels C2 Low Opiate and C3 Low Opiate are liquid, human urine-based controls containing drugs, drug metabolites, preservatives (0.1% sodium azide), and stabilizers. Used in clinical laboratories by technicians to monitor the performance of urine toxicology confirmatory procedures. The device provides known concentrations of analytes (including creatinine, pH, and specific gravity) to verify the accuracy and precision of laboratory testing methods. By comparing the laboratory's measured results against the expected values of the control, clinicians ensure the reliability of patient test results, thereby supporting accurate clinical decision-making in toxicology screening and confirmation.

Clinical Evidence

Bench testing only. Stability studies confirmed that all analytes remain stable for 30 days when stored at 2-8°C after opening. Shelf life is established at 24 months when stored at 2-8°C. No clinical data or human subject studies were required or provided.

Technological Characteristics

Liquid matrix derived from human urine with added animal-origin constituents, drugs, metabolites, preservatives (0.1% sodium azide), and stabilizers. Analytes include drugs of abuse, creatinine, pH, and specific gravity. Storage: 2-8°C. No electronic, mechanical, or software components.

Indications for Use

Indicated for use as a quality control material in clinical laboratories to monitor the performance of urine toxicology confirmatory procedures. No specific patient population, age, or gender restrictions apply as it is a laboratory control product.

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 (K981590)

Submission Summary (Full Text)

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K02/415

# Summary of Safety and Effectiveness

MAY 2 9 2002

Liquichek™ Urine Toxicology Control Levels C2 Low Opiate and C3 Low Opiate

#### 1.0 Submitter

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

### Contact Person

Ofelia Cachola Regulatory Affairs Specialist Telephone: [phone]

## Date of Summary Preparation

May 1, 2002

#### 2.0 Device Identification

| Product Trade Name: | Liquichek™ Urine Toxicology Control Levels C2 Low<br>Opiate and C3 Low Opiate |
|---------------------|-------------------------------------------------------------------------------|
| 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™ Urine Toxicology Control Bio-Rad Laboratories Irvine, California

Docket Number: K981590

#### 4.0 Description of Device

Liquichek 14 Urine Toxicology Control Levels C2 Low Opiate and C3 Low Opiate 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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This product contains 0.1% sodium azide as a preservative.

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

The new Liquichek™ Urine Toxicology Control claims substantial equivalence to the Liquichek™ Urine Toxicology Control currently in commercial distribution (K981590). The new Liquichek™ Urine Toxicology has additional claims for Creatinine, pH and Specific Gravity and the current product does not.

| Characteristics | Bio Rad<br>(New Device)<br>Liquichek™ Urine Toxicology<br>Control, Levels C2 Low Opiate<br>and C3 Low Opiate | Bio Rad<br>(New Device)<br>Liquichek™ Urine Toxicology<br>Control Levels C2 and C3<br>Predicate Device) |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Liquichek™ Urine Toxicology<br>Control is intended for use as<br>quality control urine to monitor<br>the performance of laboratory<br>urine toxicology confirmatory<br>procedures. | Liquichek™ Urine Toxicology<br>Control is intended for use as<br>quality control urine to monitor the<br>performance of laboratory urine<br>toxicology confirmatory<br>procedures. |
| 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 | 2-8° C for 30 days. | 2-8° C for 30 days |
| Claim | | |
| Differences | | |
| Levels | Level C2 Low Opiate = Drugs<br>added at concentrations 20-25%<br>below confirmatory cutoffs. (For<br>use with 300 ng/ml opiate cutoff) | Level C2= Drugs added at<br>concentrations 20-25% below<br>confirmatory cutoffs.<br>Level C3= Drugs added at 20-25% |

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

08_SSEUrnTX_C2LowOp

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| | Level C3 Low Opiate = Drugs<br>added at 20-25% concentrations<br>above confirmatory cutoffs. (For<br>use with 300 ng/mL opiate<br>cutoff). | concentrations above confirmatory<br>cutoffs. |
|----------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analytes | Same analytes as the predicate<br>device with the additional claims<br>for Specimen Validity criteria:<br>Creatinine, pH and Specific<br>Gravity. | D-Amphetamine,<br>d-Methamphetamine, Amobarbital,<br>Butalbital, Pentobarbital,<br>Phenobarbital, Secobarbital,<br>Alpha-Hydroxyalprazolam,<br>Nordiazepam,<br>Tetrahydrocannabinol (THC),<br>Benzoylecgonine, Ethanol,<br>Lysergic Acid Diethylamide (LSD),<br>Methadone, Methaqualone,<br>Codeine, Morphine-3-ß-D-<br>Glucuronide,<br>6-Monoacetylmorphine,<br>Phencyclidine and Propoxyphene. |

#### 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 Product claims are as follows:

- 7.1 Open vial: Once the control is opened, all analytes will be stable for 30 days when stored tightly capped at 2-8°C.
- 7.2 Shelf Life: 24 months when stored 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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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Elizabeth Platt Regulatory Affairs Manager Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, California 92618-2017

k021415 Re:

Trade/Device Name: Liquichek™ Urine Toxicology Control Levels C2 Low Opiate and C3 Low Opiate

Regulation Number: 21 CFR § 862.3280 Regulation Name: Clinical Toxicology Control Material Regulatory Class: I Product Code: DIF Dated: May 1, 2002 Received: May 3, 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, 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 (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 Sutman

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): K 6214/5

Device Name:

Liquichek™ Urine Toxicology Control Levels C2 Low Opiate and C3 Low Opiate

Indications for Use:

A quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures.

Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K021415

(Please Do NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Over-the Counter