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

The following analytes are listed in the package insert: B-type Natriuretic Peptide (BNP) CK-MB Isoenzyme C-Reactive Protein (CRP) Creatine Kinase (CK) D-dimer Digitoxin Homocysteine Myeloperoxidase (MPO) Myoglobin N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) Troponin I Troponin T

Device Description

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

Each human donor unit 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.

AI/ML Overview

This document is a 510(k) premarket notification summary for a quality control material, not an AI/ML medical device. Therefore, many of the requested categories for AI/ML device studies are not applicable.

However, I can extract information relevant to the 'acceptance criteria' and 'study' framework as much as possible for this type of device, focusing on stability studies which are analogous to performance studies for these materials.

1. Table of Acceptance Criteria and Reported Device Performance

For a quality control material, "acceptance criteria" often refer to the established stability periods under various conditions, which are then met by "reported device performance" through stability studies.

Acceptance Criteria (Stability Goal)	Reported Device Performance (Stability Achieved)
Thawed and Opened Stability:
NT-proBNP: 15 days at 2 to 8°C	15 days at 2 to 8°C
Troponin I: 10 days at 2 to 8°C	10 days at 2 to 8°C
BNP: 8 days at 2 to 8°C	8 days at 2 to 8°C
Troponin T: 4 days at 2 to 8°C	4 days at 2 to 8°C
All other analytes: 20 days at 2 to 8°C	20 days at 2 to 8°C
Frozen Aliquot Stability:
30 days at -20 to -70°C	30 days at -20 to -70°C
Shelf Life Stability:
Until expiration (goal)	36 months at -20 to -70°C

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify exact sample sizes for the stability studies (e.g., number of lots, replicates per time point). It mentions "replicate analyses" were used to derive mean values and ranges for value assignment and that "a representative sampling of this lot of control" was used for testing.
Data Provenance: The studies were performed by the manufacturer, Bio-Rad Laboratories, and/or independent laboratories. The document does not specify the country of origin of the data, but the manufacturer is based in Irvine, California, USA. The studies are prospective in nature, as they are real-time and accelerated stability studies conducted on the device itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This question is not applicable. For a quality control material, analytical values (the "ground truth" equivalent for performance testing) are established through "value assignment" processes using validated laboratory methods and instruments, not by expert consensus from individuals like radiologists. The document states: "The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents."

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in clinical image interpretation or clinical decision-making studies, not for the analytical performance of laboratory quality control materials.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools that involve human interpretation of medical images or data. The device here is a quality control material intended to monitor the precision of laboratory testing procedures.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. This device is a quality control material, not an algorithm or AI system. Its "performance" is its stability and its ability to provide target values for laboratory instruments.

7. The Type of Ground Truth Used

For the value assignment (which serves as the "ground truth" for expected analytic values), laboratory results from specific analytical methods and instruments are used. The document states, "The mean values and the corresponding ±3SD ranges printed in this insert were derived from replicate analyses and are specific for each 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 control." This is essentially analytical reference values established by validated laboratory testing.

8. The Sample Size for the Training Set

This question is not applicable. This device is a quality control material and does not involve AI/ML algorithms that require training sets.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no training set for this device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 11, 2015

BIO-RAD LABORATORIES SUZANNE PARSONS REGULATORY AFFAIRS SUPERVISOR 9500 JERONIMO ROAD IRVINE CA 92618-2017

Re: K150300

Trade/Device Name: Liquichek Cardiac Markers Plus Control LT Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I. Reserved Product Code: JJY Dated: January 26, 2015 Received: February 6, 2015

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

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 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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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 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" (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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Katherine Serrano -S

For: 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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Indications for Use

510(k) Number (if known) K150300

Device Name Liquichek Cardiac Marker Plus Control LT

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summarv

Liquichek Cardiac Markers Plus Control LT

1.0 Submitter

Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 (949) 598-1557 Fax:

Contact Person

Suzanne Parsons RA Supervisor Telephone: (949) 598-1467

Date of Summary Preparation

December 10, 2015

2.0 Device Identification

Product Trade Name: Common Name: Classifications: Product Code: Regulation Number:

Liquichek Cardiac Markers Plus Control LT Multi-Analyte Controls, All Kinds (Assayed) Class I, Reserved JJY 21 CFR 862.1660

3.0 Device to Which Substantial Equivalence is Claimed

Liquichek Cardiac Markers Plus Control LT Bio-Rad Laboratories Predicate 510(k) Number: K050537

4.0 Description of Device

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 each 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 control. Individual laboratory means should fall within the corresponding acceptable range; however, laboratory means may vary from the listed values 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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It is recommended that each laboratory establish its own means and acceptable ranges and use those provided only as guides.

6.0 Intended Use

Liquichek Cardiac Markers Plus Control LT 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

Liquichek Cardiac Markers Plus Control LT claims substantial equivalence to Liguichek Cardiac Markers Plus Control LT (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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Table 1: Comparison between the predicate and new Liquichek Cardiac Markers Plus Control LT
Characteristics	Predicate Device	New Device
	Liquichek Cardiac Markers Plus Control LT(K050537)	Liquichek Cardiac Markers Plus Control LT
Similarities
Product Name	Liquichek Cardiac Markers Plus Control LT	Liquichek Cardiac Markers Plus Control LT
Intended Use	Liquichek Cardiac Markers Plus Control LT isintended for use as an assayed quality control serumto monitor the precision of laboratory testingprocedures for the analytes listed in this packageinsert.	Liquichek Cardiac Markers Plus Control LT isintended for use as an assayed quality control serumto monitor the precision of laboratory testingprocedures for the analytes listed in this packageinsert.
Base Matrix	Human Serum	Human Serum
Form	Liquid	Liquid
Thawed and OpenedStability	20 days at 2 to 8°C	20 days at 2 to 8°C
	Except N-terminal pro-Brain Natriuretic Peptide (NT-proBNP): 15 days at 2 to 8°CTroponin I: 10 days at 2 to 8°CB-type Natriuretic Peptide (BNP): 8 days at 2 to8°CTroponin T: 4 days at 2 to 8°C	Except N-terminal pro-Brain Natriuretic Peptide(NT-proBNP): 15 days at 2 to 8°CTroponin I: 10 days at 2 to 8°CB-type Natriuretic Peptide (BNP): 8 days at 2to 8°CTroponin T: 4 days at 2 to 8°C
Frozen AliquotStability	30 days at -20 to -70°C	30 days at -20 to -70°C
Shelf life	at -20 to -70°C until expiration	at -20 to -70°C until expiration
Differences
Analytes	ContainsB-type Natriuretic Peptide (BNP)CK-MB IsoenzymeC-Reactive Protein (CRP)Creatine Kinase (CK)DigitoxinHomocysteineMyoglobinN-terminal pro-Brain NatriureticPeptide (NT-proBNP)Troponin ITroponin TDoes not contain:D-dimerMyeloperoxidase (MPO)	ContainsB-type Natriuretic Peptide (BNP)CK-MB IsoenzymeC-Reactive Protein (CRP)Creatine Kinase (CK)D-dimerDigitoxinHomocysteineMyeloperoxidase (MPO)MyoglobinN-terminal pro-Brain NatriureticPeptide (NT-proBNP)Troponin ITroponin T

8.0 Statement of Supporting Data

Real time stability studies were performed to establish Thawed and Opened stability claims. Accelerated stability studies were performed for establishing the shelf life stability. The stabilities for Liquichek Cardiac Markers Plus Control LT are as follows:

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Thawed and Opened Stability:	N-terminal pro-Brain Natriuretic Peptide (NT-proBNP): 15 days at 2 to 8°C
	Troponin I: 10 days at 2 to 8°C
	B-type Natriuretic Peptide (BNP): 8 days at 2 to 8°C
	Troponin T: 4 days at 2 to 8°C
	All other analytes: 20 days at 2 to 8°C
Frozen Aliquot Stability:	30 days at -20 to -70°C
Shelf Life Stability:	36 months at -20 to -70°C

9.0 Conclusion

Based on the performance characteristics indicated above, 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.

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.