LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398)

K971954 · Bio-Rad · JJY · Jun 11, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971954
• Device Name: LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398)
• Applicant: Bio-Rad
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jun 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Liquichek Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

Device Story

Liquichek Urine Chemistry Control is an assayed quality control material used in clinical laboratories to monitor the precision of urine chemistry testing procedures. The device is prepared from human urine supplemented with human and non-human constituents and pure chemicals; it contains <0.1% sodium azide as a preservative. Provided in liquid form, the control is stored at 2-8°C. Laboratory personnel use the control to validate the accuracy and precision of their analytical methods by comparing observed results against established assay values. This monitoring process helps ensure the reliability of patient sample testing, thereby supporting accurate clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Liquid-form quality control material; matrix consists of human urine with added human/non-human constituents and pure chemicals; contains <0.1% sodium azide preservative; stored at 2-8°C; two-level configuration.

Indications for Use

Indicated for use as an assayed quality control material to monitor the precision of laboratory urine chemistry testing procedures. No specific patient population is targeted as this is an in vitro diagnostic control product for laboratory use.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Human Urine Control (Quantimetrix Corporation)

Submission Summary (Full Text)

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K971954

Image /page/0/Picture/1 description: The image shows the logo for Bio-Rad Laboratories, a company that develops, manufactures, and markets a broad range of products and services to the life science research and clinical diagnostics markets. The logo is white text on a black background. The text is in a bold, sans-serif font.

**Bio-Rad**
**Laboratories**

m. CA 9. hone (714) 630

June 11, 1997

## 510(k) Summary

Submitter Bio-Rad Laboratories, ECS Division 3726 E. Miraloma Avenue Anaheim, CA 92806 [phone] Fax [phone]

Contact Person Elizabeth Platt

Date of Summary Preparation May 23, 1997

Device (Trade & Common Name) Liquichek Urine Chemistry Control

Classification Name Class I. 75JJY CFR 862.1660: Quality Control Material (Assayed and Unassayed)

Devices to Which Substantial Equivalence is Claimed Human Urine Control Quantimetrix Corporation Redondo Beach, CA

## Statement of Intended Use

Liquichek Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

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Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad. The text "BIO-RAD" is written in white, bold, sans-serif letters. The text is set against a black, rounded rectangle.

**Bio-Rad**
Laboratories

ECS Division 3726 E. Miraloma Avenue naheim, CA 92806 Telephone [phone] Toll Free [phone]

## Description of the Device

Liquichek Urine Chemistry Control is prepared from human urine with added constituents of human and non-human origin and pure chemicals. The control is provided in liquid form for convenience. 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 Chemistry Control and the devices to which substantial equivalence is claimed.

| | Bio-Rad Laboratories<br>Liquichek Urine Chemistry Control | Quantimetrix Corporation<br>Human Urine Control |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Intended<br>Use | an assayed quality control urine<br>to monitor the precision of<br>laboratory testing procedures for<br>the analytes listed in this<br>package insert. | a means for monitoring human<br>urine assay methods to validate<br>quantitation of patient samples. |
| Levels | Two | Two |
| Form | Liquid | Liquid |
| Open<br>Vial<br>Claim | 30 Days at 2-8°C | 24 Months at 2-8°C |
| Matrix | Human Urine | Human Urine |
| Storage | 2-8°C | 2-8°C |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 11 1997

Elizabeth Platt Staff Regulatory Affairs Representative Bio-Rad Laboratories 3726 E. Miraloma Avenue Anaheim, California 92806

Re : K971954 Liquichek Urine Chemistry Control Requlatory Class: I Product Code: JJY May 23, 1997 Dated: Received: May 28, 1997

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, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. ਰ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the CMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: 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 findinq 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 requlation (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 Gutman

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

510(k) Number: Device Name: Liquichek Urine Chemistry Control 参

Indications for Use:

Liquichek Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

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

(Concurrence of CDRH, Office of Device Evaluation)

(Division Sign-Off)
Division of Clinical Laboratory Devices

| 510(k) Number | 8971954 |
|---------------|---------|
|---------------|---------|

| Prescription Use | | OR | Over-The Counter Use | |
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