LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)

K042865 · Bio-Rad · DIF · Nov 24, 2004 · Clinical Toxicology

Device Facts

• Record ID: K042865
• Device Name: LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)
• Applicant: Bio-Rad
• Product Code: DIF · Clinical Toxicology
• Decision Date: Nov 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Intended Use

Liquichek Urine Toxicology Control (Levels S1S and S2S) is intended for use as quality controls urine to monitor the performance of laboratory urine toxicology enzyme immunoassay (EIA) screening procedures.

Device Story

Liquichek Urine Toxicology Control (Levels S1S and S2S) is a liquid quality control material prepared from human urine; contains added drugs of abuse, metabolites, preservatives, stabilizers, and animal-derived constituents. Used in clinical laboratories to monitor performance of urine toxicology enzyme immunoassay (EIA) screening procedures. Level S1S contains analytes at 20–25% below EIA cutoff levels; Level S2S contains analytes at 20–25% above EIA cutoff levels. Healthcare providers use the control to verify assay accuracy and precision; results help ensure reliability of patient drug screening tests.

Clinical Evidence

No clinical data. Performance is supported by bench testing, specifically stability studies confirming a 30-day open-vial stability and a three-year shelf life when stored at 2-8°C.

Technological Characteristics

Liquid matrix derived from human urine; contains drugs of abuse, metabolites, preservatives, and stabilizers. Analyte concentrations calibrated to SAMHSA-recommended EIA cutoff levels. Storage: 2–8 °C. Stability validated via GC/MS and immunoassay.

Indications for Use

Indicated for use as quality control urine to monitor the performance of laboratory 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 Urine Toxicology Control (Levels S1E and S2E) (K022707)

Submission Summary (Full Text)

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K042865

Page 1 of 2

### Summary of Safety and Effectiveness Liquichek Urine Toxicology Control (Levels S1S and S2S)

#### 1.0 Submitter

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

## Contact Person

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

## Date of Summary Preparation

October 15, 2004

#### Device Identification 2.0

Product Trade Name: Liquichek Urine Toxicology Control (Levels S1S and S2S)

| 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 (Levels S1E and S2E) Bio-Rad Laboratories Irvine, California

Docket Number: K022707

#### 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.

#### 5.0 Statement of Intended Use

Liquichek Urine Toxicology Control (Levels S1S and S2S) is intended for use as quality controls urine to monitor the performance of laboratory urine toxicology enzyme immunoassay (EIA) screening procedures.

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

The new Liquichek Urine Toxicology Controls (Levels S1S and S2S) claimsubstantial equivalence to the Liquichek Urine Toxicology Controls (Levels S1E and S2E) currently in commercial distribution (K022707).

| | Bio-Rad Liquichek Urine Toxicology Control<br>(Levels S1E and S2E)<br>(Predicate Device K022707) | Bio-Rad Liquichek Urine Toxicology Control<br>(Levels S1S and S2S)<br>(New Device) |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Similarities | |
| Intended Use | Liquichek Urine Toxicology Control (Levels S1E and S2E) are intended for use as quality controls urine to monitor the performance of laboratory urine toxicology enzyme immunoassay (EIA) screening procedures. | Liquichek Urine Toxicology Control (Levels S1S and S2S) are intended for use as quality controls urine to monitor the performance of laboratory urine toxicology enzyme immunoassay (EIA) 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 |
| Differences | | |
| Drugs | Contains: | Contains: |
| | d-Methamphetamine<br>9-COOH-11-nor-Δ9-THC<br>Benzoylecgonine<br>Morphine (Free)<br>Phencyclidine<br>Secobarbital<br>Lormetazepam<br>Ethanol<br>LSD<br>Methadone<br>Methaqualone<br>Propoxyphene<br>Tricyclic Antidepressants (nortriptyline) | d-Methamphetamine<br>9-COOH-11-nor-Δ9-THC<br>Benzoylecgonine<br>Morphine (Free)<br>Phencyclidine<br>3,4-Methylenedioxymethamphetamine (MDMA) |
| | Does not contains | Does not contains |
| | 3,4-Methylenedioxymethamphetamine (MDMA) | Secobarbital<br>Lormetazepam<br>Ethanol<br>LSD<br>Methadone<br>Methaqualone<br>Propoxyphene<br>Tricyclic Antidepressants (nortriptyline) |

### 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 Levels S1S and S2S. Product claims are as follows:

- 7.1 Open vial: 30 days at 2-8°C.
- 7.2 Shelf Life: Three years stored at 2-8 °C
- Real time studies will be ongoing to support the shelf life of this product. 7.3

:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 2 4 2004

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

k042865 Re:

R042005
Trade/Device Name: Liquichek Urine Toxicology Control (Level S1S and S2S) Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DIF Dated: October 15, 2004 Received: October 18, 2004

Dear Ms. Platt:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfall in the encreases in 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). Tou may, therefore, market the device, subject to the general controls provisions of the Act. The r ou mayy aters, worksions 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 or and I 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,

Sincerely yours,

Cornelia B. Parks

Cornelia B. Rooks, MA Acting 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 S1S and S2S) |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use: | Liquichek Urine Toxicology Control is intended for use as quality control urine to monitor the performance of laboratory urine toxicology enzyme Immunoassay (EIA) screening procedures. |

Prescription Use X (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)

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