LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648

K012656 · Bio-Rad · JJT · Sep 6, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012656
• Device Name: LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
• Applicant: Bio-Rad
• Product Code: JJT · Clinical Chemistry
• Decision Date: Sep 6, 2001
• 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 for analytes 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 clinical laboratory testing procedures for these specific cardiac markers. The control is stored frozen (-20°C or colder) and thawed for use. Once thawed and opened, it remains stable for a limited duration (10-20 days depending on the analyte) when stored at 2-8°C. Healthcare providers use the results from this control to verify the performance and accuracy of their diagnostic testing equipment, ensuring reliable patient test results for cardiac marker assays.

Clinical Evidence

Bench testing only. Stability studies were conducted to determine open-vial stability and shelf life. Results support a two-year shelf life at -20°C or colder and specific open-vial stability durations (10 days for Troponin I and Homocysteine; 20 days for Myoglobin, CK-MB, and Digitoxin) when stored at 2-8°C.

Technological Characteristics

Human serum-based control containing preservatives and stabilizers. Liquid form. Storage at -20°C or colder. Analyte composition: Troponin-I, Troponin T, Myoglobin, CK-MB, Homocysteine, and Digitoxin.

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for cardiac marker analytes 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 (K980556)

Submission Summary (Full Text)

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Summary of Safety and Effectiveness Liquichek™ Cardiac Markers Control LT

012656

#### 1.0 Submitter

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

## Contact Person

Maria Zeballos Regulatory Affairs Specialist Telephone: [phone]

# Date of Summary Preparation

August 7, 2001

#### 2.0 Device Identification

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

### CFR 862.1660 Regulation Number:

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

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

Docket Number: K980556

#### 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.

#### 5.0 Statement of Intended Use

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.

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

The new Liquichek™ Cardiac Markers Control LT claims substantial equivalerce to the The Trew Equichers Control LT currently in commercial distribution (K980556). Elquichek™ Cardiac Markers Control LT contains Homocysteine and Digitoxin
The new Liquichek™ Cardiac Markers Control LT contains Homocysteine and Digitoxin The new Liquicher - Ourdiae Markers Control Liquichek™ Cardiac Markers Control LT does not contain CK Total, LD-1 Isoenzyme and the current product does.

| | Bio Rad | Bio Rad |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Liquichek™ Cardiac Markers Control LT<br>(New Device) | Liquichek™ Cardiac Markers Control LT<br>(Predicate Device) |
| Similarities | | |
| Intended<br>Use | Liquichek™ Cardiac Markers Control LT is<br>intended for use as an assayed quality<br>control serum to monitor the precision of<br>laboratory testing procedures for analytes<br>listed in the package insert. | Liquichek™ Cardiac Markers Control LT is<br>intended for use as an assayed quality control<br>serum to monitor the precision of an individual<br>laboratory's specific cardiac marker<br>procedures. |
| Form | Liquid | Liquid |
| Matrix | Human serum based | Human serum based |
| Differences | | |
| Storage<br>(Unopened) | -20°C or colder<br>until expiration date | -10 °C to -20°C<br>until expiration date |
| Open Vial<br>Claim<br>At 2-8°C | Troponin-I and Homocysteine 10 days<br>Myoglobin, CK-MB, and Digitoxin 20 days | CK, Total, CK-MB, LD-1 Isoenzyme 20 days<br>Myoglobin, Troponin I, Troponin T 10 days |
| Analytes | Contains: Troponin-I, Troponin T,<br>Myoglobin, CK-MB, Homocysteine and<br>Digitoxin<br>Does not Contain: CK Total, LD-1 | Contains CK, Total, CK-MB, LD-1 Isoenzyme,<br>Myoglobin, Troponin I, Troponin T<br>Does not contain: Homocysteine and Digitoxin |

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

#### Summary of Performance Data 7.0

Stability studies have been performed to determine the open vial stability and shelf life or 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 7.1 Open var. Onlo the sentle tightly capped at 2-8℃, with the following exceptions: Troponin I and Homocysteine will be stable for 10 days.
- Do not refreeze the control once it has been thawed. 7.2
- Shelf Life: Two years when stored at -20 °C or colder 7.3

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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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP = 6 2001

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

K012656 Re:

Trade/Device Name: Liquichek Cardiac Markers Control LT Regulation Number: 21 CFR 862.1660 Regulatory Class: I, reserved Product Code: JJT, JJY Dated: August 7, 2001 Received: August 13, 2001

Dear Ms. Platt:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to I cachi 1 ood, Drag, and sions of the Act. The general controls provisions of the Act include the goneral controls pro 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remarket ripproval), it the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such periodio Crip millions of comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal addition, I DIA may pushine to your premarket notification submission does not affect - 22 cer. I reason wight have under sections 531 through 542 of the Act for devices under the any obligation you mightion Control provisions, or other Federal laws or regulations.

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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 predication. THE I Dr 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 rr you desire specific and vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 101 101 - 10 questions on the promotion and advertising of your device, [phone]. Traditions 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 mionitation on your roped 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,

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):_K0126562626262

Liquichek™ Cardiac Markers Control LT Device Name:

Indications for Use:

An assayed quality control serum to monitor the precision of laboratory teating procedures for analytes listed in the package insert.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use_

Over-the Counter use_

Kesia Alexander f/k/a Joan Coper
(Division Sign Off)

or

(Division Sign-Off)
Division of Clinical Laboratory Levices
510(k) Number K012656