LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL

K021498 · Bio-Rad · JJT · May 24, 2002 · Clinical Chemistry

Device Facts

• Record ID: K021498
• Device Name: LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
• Applicant: Bio-Rad
• Product Code: JJT · Clinical Chemistry
• Decision Date: May 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Liquichek Cardiac Markers Control LT is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures listed in the package insert.

Device Story

Liquichek Cardiac Markers Control LT is a liquid, human serum-based quality control material containing Troponin-I, Troponin T, Myoglobin, CK-MB, Homocysteine, and Digitoxin. It is used by laboratory personnel to monitor the precision of cardiac marker testing procedures. The control is stored frozen (-20°C or colder) and thawed for use. Once thawed and opened, it remains stable for 20 days at 2-8°C (10 days for Troponin-I, Troponin T, and Homocysteine). The device provides a known reference point for laboratory assays, allowing clinicians to verify the accuracy and reliability of patient test results, thereby ensuring consistent diagnostic performance for cardiac conditions.

Clinical Evidence

No clinical data. Stability studies were performed to determine shelf life and open-vial stability. Real-time studies are ongoing to support the two-year shelf life claim.

Technological Characteristics

Human serum-based control material; contains preservatives and stabilizers; liquid form; stored at -20°C or colder; no sodium azide; broad-spectrum anti-microbial cocktail (<0.1% concentration).

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for cardiac markers in a clinical laboratory setting.

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 (K012656)
• Liquichek Cardiac Markers Control (K961828)

Submission Summary (Full Text)

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**MAY 24 2002**

K021498

Page 1 of 3

Bio-Rad Laboratories Premarket Notification Section 510(k) for Liquichek™ Cardiac Markers Control LT Summary of Safety and Effectiveness

> Summary of Safety and Effectiveness Liquichek™ Cardiac Markers Control LT

#### 1.0 Submitter

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

# Contact Person

Maria Zeballos Requlatory Affairs Specialist [phone] Telephone:

# Date of Summary Preparation

May 8, 2002

#### 2.0 Device Identification

Liquichek™ Cardiac Markers Control LT Product Trade Name: Enzyme Controls, (Assayed and unassayed) Common Name: Class I Classifications: 75JJT Product Code: CFR 862.1660 Regulation Number:

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

Bio-Rad Laboratories Irvine, California

Liquichek™ Cardiac Markers Control LT Docket Number: K012656

Liquichek™ Cardiac Markers Docket Number: K961828

#### Description of Device 4.0

Liquichek™ Cardiac Markers Control LT is prepared from human serum with added constituents of human and animal origin, preservatives and stabilizers. The control is provided in liquid form for convenience.

#### Statement of Intended Use 5.0

Liquichek™ Cardiac Markers Control LT is intended for use as an assayed quality control serum to monitor the precision of laboratory procedures listed in the package insert.

08_SSE_645_cardiac 5/02

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## 6.0 Preservatives:

The Liquichek™ Cardiac Markers Control LT does not contain sodium azide as a preservative. It contains a broad-spectrum anti-microbial cocktail as a preservative 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

Cardiac Markers Control LT claims substantial equivalence to the Liquichek™ Liquichek™ Cardiac Markers Control LT and Liquichek™ Cardiac Markers Control currently in commercial distribution.

| | Bio Rad | Bio Rad | Bio Rad |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Liquichek™ Cardiac Markers<br>Control LT<br>(New Device) | Liquichek™ Cardiac Markers<br>Control LT<br>(Predicate Device K012656) | Liquichek™ Cardiac Markers<br>Control<br>(Predicate Device K961828) |
| <b>Similarities</b> | | | |
| Intended Use | Liquichek™ Cardiac Markers<br>Control LT is intended for use as an<br>assayed quality control serum to<br>monitor the precision of laboratory<br>testing procedures for analytes<br>listed in the package insert. | Liquichek™ Cardiac Markers<br>Control LT is intended for use as an<br>assayed quality control serum to<br>monitor the precision of an<br>individual laboratory's specific<br>cardiac marker procedures. | Liquichek Cardiac Markers Control<br>is intended for use as an assayed<br>quality control serum to monitor the<br>precision of laboratory testing<br>procedures listed in the package<br>insert. |
| Form | Liquid | Liquid | Liquid |
| Matrix | Human serum based | Human serum based | Human serum based |
| <b>Differences</b> | | | |
| Storage<br>(Unopened) | -20°C or colder<br>Until expiration date | -20°C or colder<br>Until expiration date | -10 °C to -20°C<br>Until expiration date |
| Open Vial Claim<br>At 2-8°C | Troponin-I, Troponin T and<br>Homocysteine: 10 days<br>Myoglobin, CK-MB, and Digitoxin:<br>20 days | Troponin-I and Homocysteine<br>10 days<br>Myoglobin, CK-MB, and Digitoxin<br>20 days | Myoglobin, Troponin I, Troponin T<br>10 days<br>CK, Total, CK-MB, LD-1 Isoenzyme<br>20 days |
| Analytes | Contains: Troponin-I, Troponin T,<br>Myoglobin, CK-MB, Homocysteine<br>and Digitoxin | Contains: Troponin-I, Myoglobin,<br>CK-MB, Homocysteine and<br>Digitoxin<br>No claim is made for expected<br>values or stability of Troponin T. | Contains CK, Total, CK-MB, LD-1<br>Isoenzyme, Myoglobin, Troponin I<br>and Troponin T. |

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

## 8.0 Summary of Performance Data

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

- Open vial: Once the control material is thawed and opened, all analytes will be 8.1 stable for 20 days when stored tightly capped at 2-8°C, with the following exceptions: Troponin I. Troponin T and Homocysteine will be stable for 10 days.
- Do not refreeze the control once it has been thawed. 8.2

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Shelf Life: Two years when stored at -- 20 °C or colder 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/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other. The profiles are depicted in a simple, abstract manner.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# MAY 2 4 2002

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

Re: k021498

Trade/Device Name: Liquichek™ Cardiac Markers Control LT Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJT Dated: May 8, 2002 Received: May 9, 2002

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) Number (if known): K021498

Device Name: Liquichek™ Cardiac Markers Control LT

Indications for Use:

Liquichek Cardiac Markers Control LT is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures listed in the package insert.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription use | <div style="display:inline-block;"> <img height="16" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAERlWElmTU0AKgAAAAgAAYdpAAQAAAABAAAAGgAAAAAAA6ABAAMAAAABAAEAAKACAAQAAAABAAAAEKADAAQAAAABAAAAEAAAAAA0UqDQAAAAjUlEQVQ4y2NgGAXUBowMDAwY8wABRgYGBiQAcwwAApsClYkCUAAAAABJRU5ErkJggg==" width="16"/> </div> | or | Over-the Counter use |
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| | <hr/> |
|---------------|-----------------------------------------|
| | Juan Cooper |
| | (Division Sign-Off) |
| | Division of Clinical Laboratory Devices |
| 510(k) Number | K021498 |