LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4

K052838 · Bio-Rad · GGM · Nov 9, 2005 · Hematology

Device Facts

• Record ID: K052838
• Device Name: LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4
• Applicant: Bio-Rad
• Product Code: GGM · Hematology
• Decision Date: Nov 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

Liquichek Diabetes 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.

Device Story

Liquichek Diabetes Control is a liquid, human whole blood-based quality control material containing preservatives and stabilizers. It is used in clinical laboratory settings to monitor the precision of testing procedures for specific analytes, including Hemoglobin A1C and Total Hemoglobin. The device serves as a reference material to ensure the accuracy and reliability of laboratory diagnostic assays. Healthcare professionals use the control to validate instrument performance and monitor testing consistency over time. By providing a stable, assayed sample, the device helps laboratories maintain quality standards, ultimately supporting the accuracy of patient diagnostic results.

Clinical Evidence

No clinical data. Stability studies were performed to validate shelf life (3 years at -10 to -70°C or 6 months at 2-8°C) and open-vial stability (14 days at 2-8°C).

Technological Characteristics

Liquid human whole blood-based control material. Contains preservatives and stabilizers. Three levels of assayed values for Hemoglobin A1C and Total Hemoglobin. Storage: -10°C to -70°C (3 years) or 2°C to 8°C (6 months). Open vial stability: 14 days at 2°C to 8°C.

Indications for Use

Indicated for professional use as an assayed quality control material to monitor the precision of laboratory testing procedures for Hemoglobin A1C and Total Hemoglobin.

Regulatory Classification

Identification

A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).

Special Controls

*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• Lyphochek Diabetes Control (K862186)

Submission Summary (Full Text)

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## Bio-Rad Laboratories Liquichek Diabetes Control Summary of Safety and Effectiveness

K052838

NOV - 9 2005

#### 1.0 Submitter

**NOV - 9 2005**

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

## Contact Person

Maria Zeballos Regulatory Affairs Specialist Telephone: [phone]

## Date of Summary Preparation

September 16, 2005

#### 2.0 Device Identification

| Product Name: | Liquichek Diabetes Control |
|------------------|------------------------------------------------------------------------|
| Common Name: | Hematology and Pathology Devices<br>Hematology quality control mixture |
| Classifications: | Class II |

| Classifications: | Class II |
|--------------------|-----------------|
| Product Code: | GGM |
| Regulation Number: | 21 CFR 864.8625 |

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

Lyphochek Diabetes Control Bio-Rad Laboratories Irvine, California 92618

510 (k) Number: K862186

#### 4.0 Description of Device

This is a liquid product prepared from human whole blood containing preservatives and stabilizers.

#### 5.0 Intended Use

Liquichek Diabetes 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.

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

Liguichek Diabetes Control claims substantial equivalence to the Lyphochek Diabetes Control currently in commercial distribution (K862186). Both of these are whole blood based controls .

| Characteristics | Bio-Rad Laboratories<br>Liquichek™ Diabetes Control<br>(New Device) | Bio-Rad Laboratories<br>Lyphochek Diabetes Control<br>(Predicate Device K862186) |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Liquichek Diabetes Control is intended for use as an assayed<br>quality control material to monitor the precision of laboratory<br>testing procedures for the analytes listed in the package insert. | Lyphochek Diabetes Control is intended for use as an assayed<br>quality control material to monitor the precision of laboratory<br>testing procedures for the analytes listed in the package insert. |
| Matrix | Human Whole Blood based | Human Whole Blood based |
| Preservatives | Contains preservatives | Contains preservatives |
| Differences | | |
| Form | Liquid | Lyophilized |
| Storage (Unopened) | -10C to -70°C Until expiration date or<br>2°C to 8°C for 6 months | 2°C to 8°C<br>Until expiration date |
| Open Vial Claim | 14 days at 2°C to 8 °C | 7 days at 2 to 8 °C |
| Analytes | Contains:<br>Hemoglobin A1C Total Hemoglobin Does not contain: Hemoglobin A1 Hemoglobin F Total Glycated Hemoglobin | Contains:<br>Hemoglobin A1C Hemoglobin A1 Hemoglobin F Total Glycated Hemoglobin Does not Contain: Total Hemoglobin |

Table 1. Similarities and Differences between new and predicate device.

#### 7.0 Statement of Supporting Data

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

- . Open vial Stability: 14 days at 2 to 8°C.
- . Shelf Life: 3 years at -10 to 70℃ or 6 months when stored tightly capped at 2 to 8°C.

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 seal of the Department of Health & Human Services-USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with three wavy lines extending from its body.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV - 9 2005

Ms. Maria Zeballos Regulatory Affairs Specialist Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-2017

Re: k052838

> Trade/Device Name: Liquichek Diabetes Control Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: Class II Product Code: GGM Dated: October 5, 2005 Received: October 7, 2005

Dear Ms. Zeballos:

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

Sincerely yours.

Alberto Gutz

Alberto Gutierrez, Ph.D. 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):

K052838

Device Name:

Liquichek Diabetes Control

Indications For Use:

Liquichek Diabetes 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 Benson
Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

51001 K052838