LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2, LIQUICHEK URINE TOXICOLOGY CON

K981590 · Bio-Rad · DIF · Jun 10, 1998 · Clinical Toxicology

Device Facts

• Record ID: K981590
• Device Name: LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2, LIQUICHEK URINE TOXICOLOGY CON
• Applicant: Bio-Rad
• Product Code: DIF · Clinical Toxicology
• Decision Date: Jun 10, 1998
• 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 quality control product derived from human urine, supplemented with specific drugs, drug metabolites, preservatives (0.1% sodium azide), and stabilizers. It is designed for use in clinical laboratories to monitor the performance of urine toxicology screening and confirmatory procedures. The device is provided in liquid form, ready for use, and is stable for 30 days when stored at 2-8°C. Laboratory personnel use the control to verify the accuracy and precision of assay conditions during quantitative and qualitative analysis of patient urine specimens. By providing samples with known concentrations of drugs—ranging from levels near the limit of quantitation to elevated concentrations—the control allows clinicians to validate that their testing procedures are performing within expected parameters, thereby ensuring the reliability of patient drug testing results.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Matrix: Human urine. Additives: Drugs, drug metabolites, preservatives (0.1% sodium azide), and stabilizers. Form: Liquid. Storage: 2-8°C. Stability: 30 days open vial 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 laboratory urine toxicology confirmatory procedures. No specific patient population, age, or gender restrictions apply as this is an in vitro diagnostic 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

• Liquid Drugs of Abuse Controls Medical Analysis Systems (K903430)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for Bio-Rad. The logo is in black and white, with the words "BIO-RAD" in large, bold letters. The letters are white, and they are set against a black background. The background is a rounded rectangle shape.

aboratories

ine, California 92618-2017 Telephone: [phone]

## JUN 10 1998

## 510(k) Summary

Submitter Bio-Rad Laboratories, ECS Division 9500 Jeronimo Road Irvine, CA 92618 [phone] Fax [phone]

Contact Person Elizabeth Platt

Date of Summary Preparation April 30, 1998

Device (Trade & Common Name) Liquichek Urine Toxicology Control

Classification Name Class 1, CFR 862.3280: Drug Mixture Control 91DIF

Devices to Which Substantial Equivalence is Claimed Liguid Drugs of Abuse Controls Medical Analysis Systems, Camarillo, California K903430

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

## Description of the Device

Liquichek Urine Toxicology Control is prepared from human urine with added drugs, drug metabolites, preservatives and stabilizers. The control is provided in liquid form for convenience.

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Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad. The logo is white text on a black rounded rectangle. The text reads "BIO-RAD" with a plus sign between "BIO" and "RAD".

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

This product contains 0.1% sodium azide as a preservative.

Statement of How Technological Characteristics Compare to Substantial Equivalence Device

A table is provided below comparing the similarities between the Bio-Rad Liquichek Urine Toxicology Control and the devices to which substantial equivalence is claimed.

| | Bio-Rad Liquichek<br>Urine Toxicology Control | Liquid Drugs of Abuse Controls<br>Medical Analysis Systems |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | A quality control urine to monitor<br>the performance of laboratory<br>urine toxicology confirmatory<br>procedures. | A consistent test sample of known<br>concentration for monitoring assay<br>conditions in quantitative and<br>qualitative analysis of patient urine<br>specimens for drug and drug<br>metabolites. |
| Levels | Level C1 = Drugs added at<br>concentrations<br>approximately 60%<br>below confirmatory<br>cutoffs or at LOQ<br>Level C2 = Drugs added at<br>concentrations<br>20-25% below<br>confirmatory cutoffs<br>Level C3 = Drugs added at<br>concentrations<br>20-25% above<br>confirmatory cutoffs<br>Level C4 = Elevated confirmatory<br>control | Level G2 = 20-25% below<br>GC/MS cutoff<br>Level G3 = 20-25% above<br>GC/MS cutoff<br>Level G4 = Elevated<br>GC/MS |
| Form | Liquid | Liquid |
| Open<br>Vial<br>Claim | 30 Days at 2-8°C | 30 Days at 2-8°C |
| Matrix | Human Urine | Human Urine |
| Storage | 2-8°C | 2-8°C |

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JUN 1 0 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Elizabeth Platt . Acting Regulatory Affairs/Quality Assurance Bio Rad Laboratories 9500 Jeronimo Road 92618-2017 Irvine, California

K981590 Re : Liquichek Urine Toxicology Control Requlatory Class: I Product Code: DIF Dated: April 30, 1998 Received: May 4, 1998

Dear Ms. Platt:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

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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Page 1 of 1

K9 Y 1590

Liquichek Urine Toxicology Control Device Name:

Indications for Use:

510(k) Number:

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-CONTINUE ON ANOTHER PAGE IF NEEDED)

(Concurrence of CDRH, Office of Device Evaluation)

Prescription Use

OR Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number K981159()