LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS

K031231 · Bio-Rad · JJW · Jun 18, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031231
• Device Name: LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS
• Applicant: Bio-Rad
• Product Code: JJW · Clinical Chemistry
• Decision Date: Jun 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Liquichek Urinalysis Control is intended for use as an assayed quality control urine to monitor the precision of urinalysis test procedures for the analytes listed in this package insert.

Device Story

Liquichek Urinalysis Control is a liquid-form quality control material derived from human urine, supplemented with human erythrocytes, simulated leukocytes, animal-derived constituents, chemicals, preservatives, and stabilizers. It is used in clinical laboratories to monitor the precision of urinalysis test procedures. Healthcare professionals use the control to verify the accuracy and reliability of urinalysis assays; results help ensure consistent performance of diagnostic testing. The device includes updated stability claims and expanded analyte coverage, including Creatinine and Protein-Creatinine Ratio, compared to the predicate.

Clinical Evidence

Bench testing only. Stability studies were conducted to validate open-vial stability (30 days at 2-8°C or 7 days at 18-25°C) and shelf life (30 months at 2-8°C).

Technological Characteristics

Liquid matrix derived from human urine; contains human erythrocytes, simulated leukocytes, animal-derived constituents, pure chemicals, and preservatives (5-chloro-2-methyl-2H-isothiazol-3-one). Compatible with squeezer caps. Storage at 2°C to 8°C.

Indications for Use

Indicated for use as an assayed quality control material to monitor the precision of urinalysis test procedures in clinical laboratory settings.

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™ Urinalysis Control (K965171)

Submission Summary (Full Text)

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K03/231

Page 1 of 2

# Summary of Safety and Effectiveness Liquichek™ Urinalysis 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 14, 2003

#### Device Identification 2.0

| Product Trade Name: | Liquichek™ Urinalysis Control |
|---------------------|---------------------------------------------|
| Common Name: | Urinalysis controls (Assayed and Unassayed) |
| Classifications: | Class I |
| Product Code: | JJW |
| Regulation Number: | CFR 862.1660 |

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

Liquichek™ Urinalysis Control Bio-Rad Laboratories Irvine, California

Docket Number: K965171

#### 4.0 Description of Device

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

#### 5.0 Statement of Intended Use

Liquichek Urinalysis Control is intended for use as an assayed quality control urine to monitor the precision of urinalysis test procedures for the analytes listed in this package insert.

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

The new Liquichek™ Urinalysis Control claims substantial equivalence to the Liquichek™ Urinalysis Control currently in commercial distribution (K965171).

| | Bio-Rad | Bio-Rad |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Liquichek™ Urinalysis Control<br>(New Device) | Liquichek™ Urinalysis Control<br>(Predicate Device) |
| Similarities | | |
| Intended Use | Liquichek Urinalysis Control is intended for<br>use as an assayed quality control urine to<br>monitor the precision of urinalysis test<br>procedures for the analytes listed in this<br>package insert. | Liquichek™ Urinalysis Control is intended for<br>use as an assayed quality control urine to<br>monitor the precision of laboratory dipstick and<br>microscopic testing procedures for analytes<br>listed in this package insert. |
| Form | Liquid | Liquid |
| Matrix | Urine | Urine |
| Storage | 2°C to 8°C<br>Until expiration date | 2°C to 8°C<br>Until expiration date |
| Differences | | |
| Open Vial | 30 days at 2 to 8° C or 7 days at room<br>temperature (18-25° C) | 30 days at 2-8° C or 10 immersions whichever<br>comes first or 7 days at room temperature (18<br>to 25° C) or 10 immersions whichever comes<br>first. |
| Preservatives | 5-chloro-2-methyl-2H-isothiazol-3-one | Level 2 contains Sodium Azide. |
| Squeezer Caps | Approved for Use | Not approved for use |
| Analytes | Same analytes as the predicate device with<br>the additional claims for Creatinine and<br>Protein-Creatinine Ratio. | Does not have claims for Creatinine or Protein-<br>Creatinine Ratio. |

#### 7.0 Statement of Supporting Data

Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Urinalysis Control. Product claims are as follows:

- 7.1 Open vial: Once the control is opened and stored tightly capped, all analytes will be stable for 30 days at 2 to 8°C, or 7 days at room temperature (18 to 25°C).
- 7.2 Shelf Life: 30 months when stored at 2 to 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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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized human figures in a row, connected at the shoulders and facing to the right. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

JUN 1 8 2003

k031231 Re:

Trade/Device Name: Liquichek™ Urinalysis Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJW Dated: April 14, 2003 Received: April 29, 2003

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 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 comply 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,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# 510 (k) Number (if known): KQ3 123 |

Device Name: Liquichek™ Urinalysis Control

Indications for Use:

ر من المواليد

المستق

Liquichek Urinalysis Control is intended for use as an assayed quality control urine to monitor the precision of urinalysis test procedures for the analytes listed in this package insert.

Sean Cooper
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 0.3123

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use V or Over-the Counter use