(308 days)
No
The document describes a quality control serum for laboratory testing and does not mention any AI or ML components.
No
This device is a quality control (QC) serum used to monitor the precision of laboratory testing procedures, not to treat any condition or intervene directly with a patient's health.
No
Explanation: The device is described as a "quality control serum to monitor the precision of laboratory testing procedures," not to diagnose patients.
No
The device is a quality control serum, which is a physical substance used in laboratory testing, not a software program.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring the precision of laboratory testing procedures." This is a key characteristic of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes. In this case, the control material helps ensure the accuracy of tests for various cardiac markers.
- Device Description: The description mentions it's prepared from human serum and used in a laboratory setting. This aligns with the nature of IVD materials.
- Analytes: The list of analytes are all substances measured in biological samples (like blood) to assess health status or diagnose conditions, particularly related to cardiac health.
- Quality Control: The primary function of this device is quality control, which is an essential part of ensuring the reliability and accuracy of IVD tests.
Therefore, the Liquichek Cardiac Markers Plus Control LT fits the definition and purpose of an In Vitro Diagnostic device.
N/A
Intended Use / 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 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
Product codes
JJY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratory testing procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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:
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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 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 image of three human profiles facing to the right, stacked on top of each other, representing the department's focus on people and health.
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.
1
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.
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
| 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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3
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
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.
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.
4
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.
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
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.
5
| 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 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. | 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. | ||
| Base Matrix | Human Serum | Human Serum |
| Form | Liquid | Liquid |
| Thawed and Opened | ||
| Stability | 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°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 | Except 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 | ||
| Frozen Aliquot | ||
| Stability | 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 | Contains | |
| B-type Natriuretic Peptide (BNP) | ||
| CK-MB Isoenzyme | ||
| C-Reactive Protein (CRP) | ||
| Creatine Kinase (CK) | ||
| Digitoxin | ||
| Homocysteine | ||
| Myoglobin | ||
| N-terminal pro-Brain Natriuretic | ||
| Peptide (NT-proBNP) | ||
| Troponin I | ||
| Troponin T |
Does not contain:
D-dimer
Myeloperoxidase (MPO) | Contains
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 |
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:
6
| 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.