LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK

K072835 · Bio-Rad, Diagnostics Grp. · JJY · Dec 11, 2007 · Clinical Chemistry

Device Facts

• Record ID: K072835
• Device Name: LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK
• Applicant: Bio-Rad, Diagnostics Grp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Dec 11, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Liquichek Microalbumin 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. For Prescription Use Only

Device Story

Liquichek Microalbumin Control is a liquid, human urine-based quality control material; used in clinical laboratories to monitor precision of testing procedures for microalbumin and creatinine. Device is provided in liquid form; stored at 2-8°C; stable for 30 days once opened. Healthcare providers use the control to verify the accuracy and reliability of laboratory assays; results help ensure consistent performance of diagnostic tests for patient samples. No automated processing or software is involved.

Clinical Evidence

No clinical data. Stability studies performed to validate open vial stability (30 days at 2-8°C) and shelf life (two years at 2-8°C).

Technological Characteristics

Liquid control material derived from human urine with added human-origin constituents, chemicals, preservatives, and stabilizers. Provided in 10 mL vials. Storage at 2-8°C. No specific sensing or energy source; intended for use on existing laboratory analyzers.

Indications for Use

Indicated for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for microalbumin and creatinine in urine.

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 (k020817)

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness Liquichek Microalbumin Control

K072835

#### 1.0 Submitter

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

DEC 1 1 2007

## Contact Person

Suzanne Parsons Regulatory Affairs Specialist Telephone: [phone]

## Date of Summary Preparation

September 27, 2007

#### 2.0 Device Identification

| Product Trade Name: | Liquichek Microalbumin 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: K020817

#### 4.0 Description of Device

Liquichek Microalbumin Control is prepared from human urine with added constituents of human, pure chemicals, preservatives and stabilizers. The contral is provided in Iliginal form for convenience.

#### 5.0 Statement of Intended Use

Liquichek Microalbumin 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 Microalbumin Control claims substantial equivalence to the Liquichek Urine Chemistry Control currently in commercial distribution (K020817). The new Liquichek Microalbumin Control contains claims only for microalbumin and creatinine.

| | Bio-Rad Laboratories | Bio-Rad Laboratories |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Liquichek Microalbumin Control<br>(New Device) | Liquichek Urine Chemistry Control<br>(Predicate Device) |
| Similarities | | |
| Intended Use | Liquichek Microalbumin Control is<br>intended for use as assayed quality<br>control urine to monitor the precision of<br>laboratory testing procedures for analytes<br>listed in the 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 |
| Shelf Storage<br>Claim (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 |
| Differences | | |
| Analytes | Contains: Microalbumin and creatinine | Contains: |
| | Does not contain:<br>- Amylase<br>- Calcium<br>- Chloride<br>- Cortisol<br>- Glucose<br>- Magnesium<br>- Osmolality<br>- pH<br>- Phosphorus | - Potassium<br>- Pregnancy<br>- Protein, Total<br>- Sodium<br>- Specific Gravity<br>- Urea<br>- Urea Nitrogen<br>- Uric Acid |
| | | - Amylase<br>- Calcium<br>- Chloride<br>- Cortisol<br>- Creatinine<br>- Glucose<br>- Magnesium<br>- Microalbumin<br>- Osmolality<br>- pH |
| | | - Phosphorus<br>- Potassium<br>- Pregnancy<br>- Protein, Total<br>- Sodium<br>- Specific Gravity<br>- Urea<br>- Urea Nitrogen<br>- Uric Acid |

| 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 Microalbumin Control. Product claims are as follows:

- 7.1 Open vial: Once the control material is opened, all analytes will be stable for 30 days when stored tightly capped at 2-8 °C.
- 7.2 Shelf Life: Two years when stored at 2-8 °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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## DEC 1 1 2007

Bio-Rad Laboratories Diagnostics Group c/o Ms. Suzanne Parsons Regulatory Affairs Specialist 9500 Jeronimo Road Irvine, CA 92618-2017

Re: k072835 Trade Name: Liquichek™ Microalbumin Control Levels 1 & 2 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I Product Code: JJY Dated: October 01, 2007 Received: November 16, 2007

Dear Ms. Parsons:

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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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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.V.M.

Yéan M. Cooper, M.S., D.V.M. 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:

Indications For Use:

K072835

Liquichek Microalbumin Control

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

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)

Carol C. Benson

L. Sign-Off

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Office of In Vitro Diagnostic Device Juation and Safety :

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