LIQUICHEK ELEVATED CRP CONTROL

K042837 · Bio-Rad · JJX · Nov 2, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042837
• Device Name: LIQUICHEK ELEVATED CRP CONTROL
• Applicant: Bio-Rad
• Product Code: JJX · Clinical Chemistry
• Decision Date: Nov 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Liquichek Elevated CRP Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for C-Reactive Protein (CRP).

Device Story

Liquichek Elevated CRP Control is a liquid, human serum-based quality control material used in clinical laboratories. It contains C-Reactive Protein (CRP) along with stabilizers and preservatives. The device is used by laboratory personnel to monitor the precision of analytical testing procedures for CRP. By measuring the control alongside patient samples, clinicians can verify the accuracy and reliability of their testing equipment and methods, ensuring consistent results for patient diagnosis and monitoring.

Clinical Evidence

No clinical data. Stability studies were performed to validate open vial stability (30 days at 2°C to 8°C) and shelf life (3 years at -10°C to -70°C).

Technological Characteristics

Human serum-based quality control material. Ready-to-use liquid form. Analyte: C-Reactive Protein (CRP). Compatible with specific clinical chemistry analyzers (Beckman Coulter, Dade BEHRING, Roche). Stability: 3 years closed-vial at -10 to -70°C; 30 days open-vial at 2 to 8°C. No electronic or software components.

Indications for Use

Indicated for use as a quality control serum to monitor the precision of laboratory testing procedures for C-Reactive Protein (CRP). Prescription use only.

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 Lipids Control (k012513)

Submission Summary (Full Text)

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K042837

NOV - 2 2004

Summary of Safety and Effectiveness Liquichek Elevated CRP Control

#### 1.0 Submitter

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

## Contact Person

Suzanne Parsons Regulatory Affairs Specialist Telephone: [phone]

## Date of Summary Preparation

October 12, 2004

#### 2.0 Device Identification

| Product Trade Name: | Liquichek Elevated CRP Control |
|---------------------|-------------------------------------------------------------|
| Common Name: | Single (specified) analyte controls (assayed and unassayed) |
| Classifications: | Class 1 |
| Product Code: | JJX |
| Regulation Number: | 21 CFR 862.1660 |

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

Liquichek™ Lipids Control Bio-Rad Laboratories Irvine, California

510 (k) Number: K012513

#### 4.0 Description of Device

Liquichek Elevated CRP Control is prepared from human serum with added constituents of human and animal origin, stabilizers, and preservatives. This product is provided in liquid form.

#### 5.0 Intended Use

Liquichek Elevated CRP Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for C-Reactive Protein (CRP).

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

Liquichek Elevated CRP Control claims substantial equivalence to the Liquichek Lipids Control currently in commercial distribution (K012513). Both of these are liquid, human serum based controls. Liquichek Elevated CRP Control contains only CRP and Liquichek Lipids Control is a multi-analyte control.

| | Bio-Rad Laboratories | Bio-Rad Laboratories |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | LiquichekTM Elevated CRP Control | LiquichekTM Lipids Control |
| Characteristics | (New Device) | (Predicate Device K012513) |
| | Similarities | |
| Intended Use | Liquichek Elevated CRP Control is intended for use as a<br>quality control serum to monitor the precision of laboratory<br>testing procedures for C-Reactive Protein (CRP). | Liquichek Lipids Control is intended for use as an assayed quality<br>control serum to monitor the precision of laboratory testing<br>procedures for the analytes listed in the package insert. |
| Form | Liquid | Liquid |
| Matrix | Human serum based | Human serum based |
| Preservatives | Contains preservatives | Contains preservatives |
| | Differences | |
| Storage (Unopened) | -10 to -70°C<br>Until expiration date | -10°C to -20°C<br>Until expiration date |
| Open Vial Claim | 30 days at 2°C to 8 °C | 14 days at 2 to 8°C |
| Analytes | Contains:<br>C-Reactive Protein (CRP) Does not Contain: Apolipoprotein A-1 Apolipoprotein B Cholesterol Cholesterol HDL Cholesterol LDL Lipoprotein (a) Triglycerides | Contains: Apolipoprotein A-1 Apolipoprotein B Cholesterol Cholesterol HDL Cholesterol LDL C-Reactive Protein (CRP) Lipoprotein (a) Triglycerides |

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

#### Statement of Supporting Data 7.0

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

- 30 days at 2°C to 8 °C 7.1 Open vial
- Shelf Life Stability 3 Years at -10 to -70°C 7.2.

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 features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV - 2 2004

Ms. Elizabeth Platt Quality Assurance/Regulatory Affairs Manager Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-2017

Re: k042837

Trade/Device Name: Liquichek Elevated CRP Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: October 11, 2004 Received: October 14, 2004

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,

Jean M. Cooper, U.S. DVM.

Jean M. Cooper, MS, 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):

# Ko42837

Device Name:

Liquichek Elevated CRP Control

Indications For Use:

Liquichek Elevated CRP Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for C-Reactive Protein (CRP).

Prescription Use ਮ (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

Page 1 of

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042837