LIQUICHEK CARDIAC MARKERS CONTROL LT

K980556 · Bio-Rad · JJT · Feb 25, 1998 · Clinical Chemistry

Device Facts

• Record ID: K980556
• Device Name: LIQUICHEK CARDIAC MARKERS CONTROL LT
• Applicant: Bio-Rad
• Product Code: JJT · Clinical Chemistry
• Decision Date: Feb 25, 1998
• 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 an individual laboratory's specific cardiac marker procedures.

Device Story

Liquichek Cardiac Markers Control LT is an in vitro diagnostic quality control material used in clinical laboratories. It consists of human serum supplemented with human and non-human constituents. The device is provided in liquid form and is used by laboratory personnel to monitor the precision of cardiac marker testing procedures, including Total CK, CK-MB Isoenzyme, LD-1 Isoenzyme, Myoglobin, Troponin-I, and Troponin T. By running this control alongside patient samples, clinicians verify the accuracy and reliability of their diagnostic assays. This monitoring helps ensure that laboratory results are consistent, thereby supporting accurate clinical decision-making for patients undergoing cardiac evaluation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Liquid quality control material derived from human serum with added human and non-human constituents. Analytes include Total CK, CK-MB Isoenzyme, LD-1 Isoenzyme, Myoglobin, Troponin-I, and Troponin T. Storage requirement is -10 to -20°C. Open vial stability is 20 days at 2-8°C (10 days for Troponin T).

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of laboratory cardiac marker procedures. No specific patient population, age, or gender is applicable as this is an in vitro diagnostic quality control material.

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 (K961828)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Bio-Rad Laboratories, a company that manufactures and distributes products for the life science research and clinical diagnostics markets. The logo is a black rectangle with rounded corners, and the words "BIO-RAD" are written in white, bold letters. The letters are sans-serif and are evenly spaced. The logo is simple and recognizable.

Blo-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: [phone]

808560

# FEB 2 5 1998

# 510(k) Summary

- Submitter Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA [phone] Fax [phone]
Contact Person Elizabeth Platt

Date of Summary Preparation February 12, 1998

# Device (Trade & Common Name) Liquichek Cardiac Markers Control LT

Classification Name CFR 862.1660: Quality Control Material (Assayed and Unassayed)

Devices to Which Substantial Equivalence is Claimed Liquichek Cardiac Markers Control Bio-Rad Laboratories, Anaheim, CA K961828

#### Statement of Intended Use

Liquichek Cardiac Markers Control LT is intended for use as an assayed quality control serum to monitor the precision of an individual laboratory's specific cardiac marker procedures.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad. The text "BIO-RAD" is written in white, bold, sans-serif font. The text is set against a black, rounded rectangle.

Blo-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: [phone]

### Description of the Device

Liquichek Cardiac Markers Control LT is prepared from human serum with added constituents of human and non-human origin. The control is provided in liquid form for convenience.

## Statement of How Technological Characteristics Compare to Substantial Equilavence Device

A table is provided below comparing the similarities between the Bio-Rad Liquichek Cardiac Markers Control LT and the devices to which substantial equivalence is claimed.

| | Bio-Rad Liquichek<br>Cardiac Markers Control | Bio-Rad Liquichek<br>Cardiac Markers Control LT |
|--------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Intended<br>Use | To monitor the precision of a<br>laboratories specific cardiac<br>markers procedures. | To monitor the precision of a<br>laboratories specific cardiac<br>markers procedures. |
| Form | Liquid | Liquid |
| Matrix | Human Serum | Human Serum |
| Storage | -10 to -20°C | -10 to -20°C |
| Analytes | Total CK, CK-MB<br>Isoenzyme, LD-1<br>Isoenzyme, Myoglobin,<br>Troponin-I, Troponin T | Total CK, CK-MB<br>Isoenzyme, LD-1<br>Isoenzyme, Myoglobin,<br>Troponin-I, Troponin T |
| Open Vial<br>Claim | 20 Days at 2-8°C for all<br>analytes; except Troponin T<br>which is stable for<br>10 Days at 2-8°C | 20 Days at 2-8°C for all<br>analytes; except Troponin T<br>which is stable for<br>10 Days at 2-8°C |
| Differences | Troponin I is targeted at<br>higher levels | Troponin I is targeted at<br>lower levels |

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 2 5 1998

Elizabeth Platt . Staff Regulatory Affairs Representative Bio Rad Laboratories 9500 Jeronimo Road Irvine, California 92618-2017

Re : K980556 Liquichek Cardiac Markers Control LT Requlatory Class: I Product Code: JJT February 12, 1998 Dated: Received: February 13, 1998

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 (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:

this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{3}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA deberined in your cial 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

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

{4}------------------------------------------------

Page 1 of 1

510(k) Number: k980556

Liquichek Cardiac Markers Control LT Device Name:

Indications for Use:

Liquichek Cardiac Markers Control LT is intended for use as an_assayed quality control serum to monitor the precision of an individual laboratory's specific cardiac markers procedures.

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

(Concurrence of CDRH, Office of Device Evaluation)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR Over-The Counter Use

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K980556