LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK

K140916 · Bio-Rad Laboratories · JJY · May 6, 2014 · Clinical Chemistry

Device Facts

• Record ID: K140916
• Device Name: LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK
• Applicant: Bio-Rad Laboratories
• Product Code: JJY · Clinical Chemistry
• Decision Date: May 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

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

Device Story

Liquichek Cardiac Troponins Control is a trilevel liquid control serum derived from human protein with added human/animal constituents, stabilizers, and preservatives. Used in clinical laboratories to monitor the precision of Troponin I and Troponin T testing procedures. The device provides assayed mean values and ±3SD ranges to assist laboratories in verifying test performance. It is stored frozen (-20 to -70 °C) and has a 25-day open-vial stability at 2-8 °C. The control helps healthcare providers ensure the accuracy and reliability of cardiac marker assays, which are critical for diagnosing and managing cardiac events. It is intended for professional use by laboratory technicians.

Clinical Evidence

Bench testing only. Stability studies (real-time and accelerated) were conducted to validate shelf-life (18 months at -20 to -70 °C), frozen aliquot stability (30 days at -20 to -70 °C), and thawed/opened stability (25 days at 2 to 8 °C). Acceptance criteria were met.

Technological Characteristics

Trilevel liquid control; human protein matrix; contains stabilizers and preservatives. Storage: -20 to -70 °C. No electronic components, software, or energy sources. Sterility/Safety: Human source material tested non-reactive for HBsAg, HCV, and HIV-1/HIV-2.

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for Troponin I and Troponin T. Intended for professional laboratory use.

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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K140916

Page 1 of 3

## 510(k) Summary Liquichek Cardiac Troponins Control

#### 1.0 Submitter

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

## Contact Person

Suzanne Parsons Regulatory Affairs Manager Telephone: [phone]

## Date of Summary Preparation

· May 2, 2014

#### 2.0 Device Identification

| Product Trade Name: | Liquichek Cardiac Troponins Control | |
|---------------------|----------------------------------------------------|--|
| Common Name: | Multi-Analyte Controls, All Kinds (Assayed) | |
| Review Panel: | Clinical Chemistry and Clinical Toxicology Devices | |
| Classifications: | Class I, Reserved | |
| Product Code: | JJY | |
| Regulation Number | 21 CFR 862.1660 | |

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

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

510 (k) Number: K050537

#### 4.0 Description of Device

Liquichek Cardiac Troponins Control is a trilevel liquid control prepared from human protein with added constituents of human and animal origin, stabilizers and preservatives. Liquichek Cardiac Troponins Control is intended for use as an assayed quality control to monitor the precision of Troponin I and Troponin T in laboratory testing procedures.

The human source material used to manufacture this control was tested by FDA accepted methods and found non-reactive for Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2.

MAT 6 2014

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#### 5.0 Value Assignment

The mean values and the corresponding ±3SD ranges printed in this insert were derived from multiple replicate analyses that meet acceptance criteria and are specific for the lot of product. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of the lot of product. It is recommended that each laboratory establish its own acceptable ranges and use those provided only as quides. 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.

#### 6.0 Intended use

Liquichek Cardiac Troponins Control is intended for use as an assayed 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

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

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| Characteristics | Bio-Rad Liquichek Cardiac Troponins Control<br>(New Device) | Bio-Rad Liquichek Cardiac Markers Plus Control LT<br>(Predicate Device, K050537) |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | This product is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. | This product is intended for use as a quality control serum to monitor the precision of laboratory testing procedures listed in the package insert. |
| Form | Liquid | Liquid |
| Aliquot Stability | 30 days at -20 to -70 °C | 30 days at -20 to -70 °C |
| Differences | | |
| Matrix | Human Protein | Human Serum |
| Open vial | 25 days at 2 - 8 °C | 20 days at 2 - 8 °C with the following exceptions:<br>NT-proBNP: 15 days<br>Troponin I: 10 days<br>BNP: 8 days<br>Troponin T: 4 days |
| Shelf life | At -20 to -70 °C until the expiration date | At -20 to -70 °C until the expiration date |
| Analytes | Contains:<br>Troponin I<br>Troponin T<br>Does not contain:<br>CK Total<br>CK-MB Isoenzyme<br>Digitoxin<br>Homocysteine<br>CRP<br>Myoglobin<br>NT-proBNP<br>BNP | Contains:<br>Troponin I<br>Troponin T<br>CK Total<br>CK-MB Isoenzyme<br>Digitoxin<br>Homocysteine<br>CRP<br>Myoglobin<br>NT-proBNP<br>BNP |

Table 1: Similarities and Differences between new and predicate device

#### 8.0 Statement of Supporting Data

Real-time stability studies were conducted to establish the thawed, opened and frozen Aliquot stability claims. Accelerated stability studies were conducted to establish the shelf-life stability claim. Acceptance Criteria were met to support the product claims as follows:

| Thawed and Opened Stability: | 25 days at 2 to 8 °C |
|-----------------------------------|------------------------------|
| Frozen Aliquot Stability Studies: | 30 days at -20°C to -70 °C |
| Shelf Life Stability: | 18 months at -20°C to -70 °C |

#### - 9.0 Conclusion

Based on the performance characteristics indicated above, the Bio-Rad Liquichek Cardiac Troponins Control is substantially equivalent to the predicate device K050537.

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

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Public Health Service

Food and Drug Ad 10903 New Hame Document Control Ca Silver Spring, MD 20993-0002

May 6, 2014

## BIO-RAD LABORATORIES MS SUZANNE PARSONS 9500 JERONIMO RD. IRVINE CA 92618-2017

Re: K140916

Trade/Device Name: Liquichek Cardiac Troponins Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, Reserved Product Code: JJY Dated: April 08, 2014 Received: April 10, 2014

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 cnactment 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. Please note: CDRH docs not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not miskeading.

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 cevice 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 Parts 801 and 809); 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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Page 2-Ms. Parsons

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 80) and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

## Courtney H. Lias -S

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

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) k140916

#### Device Name

Liquichek Cardiac Troponins Control

## Indications for Use (Describe)

Liguichek Cardiac Troponins Control is intended for use as an assayed quality control server to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

- Troponin I

- Troponin T

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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