LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS

K050537 · Bio-Rad · JJY · Apr 27, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050537
• Device Name: LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS
• Applicant: Bio-Rad
• Product Code: JJY · Clinical Chemistry
• Decision Date: Apr 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Liquichek™ Cardiac Markers Plus Control, Liquichek™ Cardiac Markers Plus Control LT, and Liquichek™ Cardiac Markers Plus Control LT Low are intended for use as quality control serum to monitor the precision of laboratory testing procedures listing in the package insert.

Device Story

Liquichek™ Cardiac Markers Plus Control series are liquid, human serum-based quality control materials; used in clinical laboratories to monitor precision of diagnostic testing procedures for cardiac markers. Device contains human/animal-derived constituents, preservatives, and stabilizers. Laboratory personnel use the control to verify instrument performance by comparing measured values against expected ranges provided in the package insert. Stability is maintained via frozen storage (-20°C to -70°C) with an open-vial claim of 20 days at 2-8°C. The device does not perform diagnostic analysis itself but serves as a reference standard to ensure accuracy and reliability of clinical chemistry analyzers.

Clinical Evidence

Bench testing only. Stability studies were conducted to validate shelf life (3 years at -20°C to -70°C) and open-vial stability (20 days at 2-8°C). No clinical data was required or provided.

Technological Characteristics

Liquid, human serum-based control material. Contains human/animal-derived constituents, preservatives, and stabilizers. No sodium azide; contains broad-spectrum anti-microbial cocktail (<0.1% concentration). Storage: -20°C to -70°C. Open-vial stability: 20 days at 2-8°C.

Indications for Use

Indicated for use as a quality control serum to monitor the precision of laboratory testing procedures for cardiac markers including BNP, Creatine Kinase, CRP, Homocysteine, Digitoxin, NT-proBNP, CK-MB, Myoglobin, Troponin I, and Troponin T.

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™ Cardiac Markers Control LT (k040277)

Submission Summary (Full Text)

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Summary of Safety and Effectiveness Liquichek™ Cardiac Markers Plus Controls

## 1.0 Submitter

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

## Contact Person

Suzanne S. Parsons Regulatory Affairs Specialist Telephone: [phone]

## Date of Summary Preparation

February 16, 2005

#### 2.0 Device Identification

| Product Trade Name: | Liquichek Cardiac Markers Plus Control |
|---------------------|-----------------------------------------------|
| | Liquichek Cardiac Markers Plus Control LT |
| | Liquichek Cardiac Markers Plus Control LT Low |

Common Name: Multi-Analyte Controls, all kinds (Assayed and Unassayed)

| Classifications: | Class I |
|--------------------|--------------|
| Product Code: | JJY |
| Regulation Number: | CFR 862.1660 |

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

Liquichek™ Cardiac Markers Control LT Bio-Rad Laboratories Irvine, California

Docket Number: K040277

#### 4.0 Description of Device

These products are prepared from human serum with added constituents of human and animal origin, preservatives and stabilizers. These controls are provided in liquid form.

#### 5.0 Statement of Intended Use

- 6.0 Liquichek: Cardiac Markers Plus Control, Cardiac Markers Plus Control LT and Cardiac Markers Plus Control LT Low are intended for use as a quality control serum to monitor the precision of laboratory testing procedures listed in the package insert. These products do not contain sodium azide as a preservative. They contain a broad-spectrum anti-microbial cocktail as preservatives

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- where the concentration of any one ingredient is less than 0.1%. At this low level, these ingredients are not expected to cause a health hazard to the user. And thus, domestic and international regulations do not require this type of information on the vial or box label.
#### 7.0 Comparison of the new device with the Predicate Device

Liquichek Cardiac Markers Plus Controls claims substantial equivalence to the Liquichek™ Cardiac Markers Control LT currently in commercial distribution. The new Liquichek Cardiac Markers Plus Controls contain B-type Natriuretic Peptide (BNP), Creatine Kinase, Total and C-Reactive Protein (CRP). The current product does not contain these analytes.

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

| Characteristics | Bio-Rad<br>Liquichek™ Cardiac Markers Plus Controls<br>(New Device) | Bio-Rad<br>Liquichek™ Cardiac Markers Control LT<br>(Predicate Device K040277) |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
| Intended Use | Liquichek Cardiac Markers Plus Controls are intended for use<br>as a quality control serum to monitor the precision of laboratory<br>testing procedures listed in the package insert. | Liquichek Cardiac Markers Control LT is intended for use as<br>an assayed quality control serum to monitor the precision of<br>laboratory testing procedures listed in the package insert. |
| Form | Liquid | Liquid |
| Matrix | Human serum based | Human serum based |
| | Differences | |
| Storage<br>(Unopened) | -20°C to -70°C<br>Until expiration date | -20°C or colder<br>Until expiration date |
| Open Vial Claim | 20 days at 2-8°C | All analytes 10 days except NT-proBNP 5 days at 2-8°C |
| Analytes | Contains:<br>B-type Natriuretic Peptide (BNP)<br>Creatine Kinase, Total<br>C-Reactive Protein (CRP)<br>CK-MB Isoenzyme<br>Digitoxin<br>Homocysteine<br>Myoglobin<br>N-terminal pro-B-type Natriuretic Peptide (NT-pro BNP)<br>Troponin I<br>Troponin T | Contains:<br>CK-MB Isoenzyme<br>Digitoxin<br>Homocysteine<br>Myoglobin<br>N-terminal pro-B-type Natriuretic Peptide (NT-pro BNP)<br>Troponin I<br>Troponin T<br>Does not contain<br>B-type Natriuretic Peptide (BNP)<br>Creatine Kinase, Total<br>C-Reactive Protein (CRP) |

#### 8.0 STATEMENT OF SUPPORTING DATA

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

- Open vial: All analytes will be stable for 20 days at 2 to 8°C. 8.1
- 8.2 Shelf Life: 3 years at -20°C to -70°C
- 8.3 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 Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing the wings and head. The eagle is facing to the right.

APR 2 7 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Suzanne S. Parsons Regulatory Affairs Specialist Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-2017

Re: k050537

> Trade/Device Name: Liquichek™ Cardiac Markers Plus Control Liquchek™ Cardiac Markers Plus Control LT Liquichek™ Cardiac Markers Plus Control LT Low Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: February 22, 2005 Received: March 2, 2005

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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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 vours.

Sean M. Coogen, MS, 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): | K050537 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Liquichek™ Cardiac Markers Plus Control |
| Indications For Use: | Liquichek Cardiac Markers Plus Control is intended for use as aquality control serum to monitor the precision of laboratory testingprocedures listed in the package insert. |
| Device Name: | Liquichek™ Cardiac Markers Plus Control LT |
| Indications For Use: | Liquichek Cardiac Markers Plus Control LT is intended for use as aquality control serum to monitor the precision of laboratory testingprocedures listed in the package insert. |
| Device Name: | Liquichek™ Cardiac Markers Plus Control LT Low |
| Indications For Use: | Liquichek Cardiac Markers Plus Control LT Low is intended for useas a quality control serum to monitor the precision of laboratorytesting procedures 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) Division of Clinical Laboratory Devices 510(k) Number _ 05705

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