LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK

K123663 · Bio-Rad Laboratories · JJY · Dec 27, 2012 · Clinical Chemistry

Device Facts

• Record ID: K123663
• Device Name: LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK
• Applicant: Bio-Rad Laboratories
• Product Code: JJY · Clinical Chemistry
• Decision Date: Dec 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

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

Device Story

Liquichek Cardiac Markers Plus Control LT is a liquid quality control serum derived from human serum with added human/animal constituents, chemicals, preservatives, and stabilizers. It is used in clinical laboratories to monitor the precision of testing procedures for cardiac markers, including Troponin I, CK Total, CK-MB, Digitoxin, CRP, Myoglobin, and NT-proBNP. The control is provided in liquid form. Laboratory personnel use the control to verify the performance of their testing systems by comparing results against established mean values and ±3SD ranges provided in the insert. This monitoring helps ensure the accuracy and reliability of patient test results, aiding clinicians in diagnostic decision-making for cardiac conditions.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (real-time and accelerated) were conducted to establish shelf-life (32.5 months at -20 to -50 °C) and thawed stability (10 days at 2-8 °C for both opened and unopened vials).

Technological Characteristics

Liquid control serum; human serum base with added human/animal constituents, chemicals, preservatives, and stabilizers. Analytes: Troponin I, CK Total, CK-MB, Digitoxin, CRP, Myoglobin, NT-proBNP. Storage: -20 to -50 °C. No software or electronic components.

Indications for Use

Indicated for use as a quality control serum to monitor the precision of laboratory testing procedures for specific 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.

Submission Summary (Full Text)

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K123663

Blo-Rad Laboratories Premarket Notification Section 510 (k) Liquichek Cardiac Markers Plus Control LT

Page 1 of 3

DEC 2 7 2012

### 510(k) Summary Liquichek Cardiac Markers Plus Control LT

#### 1.0 Submitter

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

### Contact Person

Suzanne Parsons Regulatory Affairs Manager Telephone: [phone]

## Date of Summary Preparation

December 20, 2012

#### 2.0 Device Identification .

| Product Trade Name: | Liquichek Cardiac Markers Plus Control LT |
|---------------------|---------------------------------------------|
| Common Name: | Multi-Analyte Controls, All Kinds (Assayed) |
| Classifications: | Class I, Reserved |
| Product Code: | JJY |
| Regulation Number: | 21 CFR 862.1660 |

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

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

510 (k) Number: K050537

#### 4.0 Description of Device

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

#### 5.0 Value Assignment

The mean values and the corresponding ±3SD ranges printed in this insert were derived from replicate analyses and are specific for this lot of product. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of product. It is recommended that each laboratory establish its own acceptable ranges and use those provided only as guides. Laboratory established ranges may vary from those listed during the life of this control. Variations over time and between laboratories may be caused by differences in laboratory technique, instrumentation and reagents, or by manufacturer test method modifications.

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#### 6.0 Intended Use

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

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

Liquichek Cardiac Markers Plus Control LT claims substantial equivalence to the Liquichek Cardiac Markers Plus Control LT currently in commercial distribution (K050537). Table 1 (below) contains comparison of similarities and differences between the new and predicate device to which substantial equivalence is claimed.

### Table 1: Simllarties and Differences between the new and predicate device

| Characteristics | Liquichek Cardiac Markers Plus Control LT<br>(New Device) | Liquichek Cardiac Markers Plus Control LT<br>(Predicate Device, K050537) |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
| | Similarities | |
| Intended Use | This product is intended for use as a quality<br>control serum to monitor the precision of<br>laboratory testing procedures for the analytes<br>listed in the package insert. | This product is intended for use as a quality<br>control serum to monitor the precision of<br>laboratory testing procedures listed in the<br>package insert. |
| Form | Liquid | Liquid |
| Matrix | Human serum | Human serum |
| | Differences | |
| Fill Volume | 2.5 mL | 3 mL |
| Thawed and Unopened | 10 days at 2 - 8 °C | None |
| Thawed & Opened | 10 days at 2 - 8 °C | 20 days at 2 - 8 °C except for:<br>NT-proBNP: 15 days<br>TnI : 10 days<br>TnT: 4 days |
| Storage Unopened<br>(Shelf life) | At -20 to -50 °C until the expiration date | At -20 to -70 °C until the expiration date |
| Frozen allquot | None | 30 days at -20 to -70 °C |
| Analytes | Contains:<br>Troponin I<br>Creatine Kinase, Total (CK Total)<br>CK-MB Isoenzyme<br>Digitoxin<br>C-Reactive Protein(CRP)<br>Myoglobin<br>N-terminal pro-Brain Natriuretic Peptide (NT-proBNP)<br>Does not contain:<br>Troponin T<br>Homocysteine<br>BNP | Contains:<br>Troponin I<br>Creatine Kinase, Total (CK Total)<br>CK-MB Isoenzyme<br>Digitoxin<br>C-Reactive Protein(CRP)<br>Myoglobin<br>N-terminal pro-Brain Natriuretic Peptide (NT-proBNP)<br>Troponin T<br>Homocysteine<br>BNP (Not listed in the insert) |

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#### 8.0 Statement of Supporting Data

Real-time stablity studies were conducted to establish the thawed stablity claims (openvial and unopened). Accelerated stability studies were conducted to establish the shelflife claims at -20 to -50 °C. Based on the available data, product claims are as follows:

| Thawed and Opened: | 10 days at 2 to 8°C |
|-----------------------|-----------------------------|
| Thawed and Unopened: | 10 days at 2 to 8°C |
| Shelf Life Stability: | 32.5 months at -20 to -50°C |

#### 9.0 Conclusion

Based on the performance characteristics indicated above, the Bio-Rad Liquichek Cardiac Markers Plus Control LT is substantially equivalent to the predicate device, k050537.

All supporting data is retained on file at Bio-Rad Laboratories.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, creating a sense of unity and connection.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 27, 2012

Bio-Rad Laboratories c/o Suzanne Parsons 9500 Jeronimo Road Irvine, CA 92618-2017

Re: k123663

Trade/Device Name: Liquichek Cardiac Markers Plus Control LT Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: Class I, reserved Product Code: JJY Dated: November 26, 2012 Received: November 28, 2012

Dear Ms. Suzanne Parsons:

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 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 yours,

for Denise Johnson-lyles -S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K123663

Device Name: Liquichek Cardiac Markers Plus Control LT

Indications for Use:

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

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Ruta Chander

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

123663 510(k)