LIQUICHEK URINE CHEMISTRY CONTROL

K020817 · Bio-Rad Laboratories, Inc. · JJY · Apr 12, 2002 · Clinical Chemistry

Device Facts

• Record ID: K020817
• Device Name: LIQUICHEK URINE CHEMISTRY CONTROL
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Apr 12, 2002
• 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 analytes listed in the package insert.

Device Story

Liquichek™ Urine Chemistry Control is a liquid, human urine-based quality control material containing added human/animal-derived constituents, chemicals, preservatives, and stabilizers. It is used in clinical laboratories to monitor the precision of urine chemistry testing procedures. The device provides a stable, assayed control for various analytes, including the addition of Cortisol compared to the predicate. Laboratory personnel use the control to verify the accuracy and precision of their analytical systems. By comparing observed results against the provided assay values, clinicians ensure the reliability of patient test results, thereby supporting accurate clinical decision-making.

Clinical Evidence

No clinical data. Stability studies were performed to establish shelf life (18 months at 2-8°C) and open-vial stability (30 days at 2-8°C).

Technological Characteristics

Liquid, human urine-based matrix. Contains analytes: Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, Magnesium, Microalbumin, Osmolality, pH, Phosphorus, Potassium, Pregnancy, Protein-Total, Sodium, Specific Gravity, Urea, Urea Nitrogen, Uric Acid. Storage: 2-8°C. Open vial stability: 30 days at 2-8°C.

Indications for Use

Indicated for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for analytes listed in the package insert. No specific patient population, age, or gender restrictions are defined as this is a laboratory quality control material.

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

• Liquichek™ Urine Chemistry Control (K971954)

Submission Summary (Full Text)

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**APR 1 2 2002**

K020817

Page 1 of 2

Bio-Rad Laboratories Premarket Notification Section 510(k) for Liquichek™ Urine Chemistry Control Summary of Safety and Effectiveness

### Summary of Safety and Effectiveness Liquichek™ Urine Chemistry Control

#### 1.0 Submitter

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

### Contact Person

Maria Zeballos Regulatory Affairs Specialist Telephone: [phone]

## Date of Summary Preparation

March 11. 2002

#### 2.0 Device Identification

| Product Trade Name: | Liquichek™ Urine Chemistry Control |
|---------------------|-------------------------------------------------|
| Common Name: | Multi-Analyte Controls, (Assayed and unassayed) |
| Classifications: | Class I |
| Product Code: | JJY |
| Regulation Number: | 21 CFR 862.1660 |

#### 3.0 Device to Which Substantial Equivalence is Claimed

Liquichek™ Urine Chemistry Control Bio-Rad Laboratories Irvine, California

Docket Number: K971954

#### 4.0 Description of Device

Liquichek™ Urine Chemistry Control is prepared from human urine with added constituents of human and animal origin, pure chemicals, preservatives and stabilizers. The control is provided in liquid form for convenience.

#### 5.0 Statement of Intended Use

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

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

Liquichek™ Urine Chemistry Control claims substantial equivalence to the Liquichek™ Urine Chemistry Control levels currently in commercial distribution (K971954). The new Liquichek™ Urine Chemistry Control contains Cortisol and the current product does not.

| Characteristics | Bio-Rad<br>Liquichek™ Urine Chemistry Control<br>(New Device) | Bio-Rad<br>Liquichek™ Urine Chemistry Control<br>(Predicate Device) |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Similarities</b> | | |
| Intended Use | Liquichek™ Urine Chemistry Control is<br>intended for use as assayed quality control<br>urine to monitor the precision of laboratory<br>testing procedures for analytes listed in the<br>package insert. | Liquichek™ Urine Chemistry Control is<br>intended for use as assayed quality control<br>urine to monitor the precision of laboratory<br>testing procedures for analytes listed in the<br>package insert. |
| Form | Liquid | Liquid |
| Matrix | Human urine based | Human urine based |
| Storage<br>(Unopened) | 2 to 8°C<br>Until expiration date | 2 to 8°C<br>Until expiration date |
| Open Vial Claim | 30 days at 2-8°C | 30 days at 2-8°C |
| <b>Differences</b> | | |
| Analytes | Contains: Amylase, Calcium, Chloride,<br>Cortisol, Creatinine, Glucose, Magnesium,<br>Microalbumin, Osmolality, pH, Phosphorus,<br>Potassium, Pregnancy, Protein- Total,<br>Sodium, Specific Gravity, Urea, Urea<br>Nitrogen, Uric Acid. | Contains: Amylase, Calcium, Chloride,<br>Creatinine, Glucose, Magnesium,<br>Microalbumin, Osmolality, pH, Phosphorus,<br>Potassium, Pregnancy, Protein- Total,<br>Sodium, Specific Gravity, Urea, Urea<br>Nitrogen, Uric Acid.<br>Does not Contain: Cortisol |

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 Chemistry Control. Product claims are as follows:

- Open vial: Once the control material is opened, all analytes will be stable for 30 7.1 days when stored tightly capped at 2-8°C.
- Shelf Life: One year and six months when stored at 2-8 ℃. 7.2

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/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

### Public Health Service

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

APR 1 2 2002

Re: k020817

Trade/Device Name: Liquichek™ Urine Chemistry Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I reserved Product Code: JJY Dated: March 11, 2002 Received: March 13, 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 1 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 11analatotal 610 or at its internet address "http://www.fda.gov/cdrb/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 Chemistry Control

Indications for Use:

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

Sean Conroy

Division Sign-Off) Division of Clinical Laboratory Devices 120817 510(k) Number --

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use______________________________________________________________________________________________________________________________________________________________ or

Over-the Counter use_