(56 days)
["K040277"]
Not Found
No
The summary describes a quality control serum for laboratory testing, with no mention of AI or ML technology in the device description, intended use, or performance studies.
No.
The device is a quality control serum intended to monitor the precision of laboratory testing procedures, not to treat or diagnose a medical condition.
No
The device is described as a quality control serum used to monitor the precision of laboratory testing procedures, not to diagnose a condition in a patient.
No
The device is a quality control serum, which is a physical substance used in laboratory testing, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "intended for use as a quality control serum to monitor the precision of laboratory testing procedures". This aligns with the definition of an IVD, which are used to examine specimens derived from the human body to provide information for diagnostic purposes. While this specific device is a control, it is used within the process of performing diagnostic tests.
- Device Description: The description mentions it is prepared from human serum with added constituents, which are typical components of materials used in laboratory testing.
- Intended User / Care Setting: The intended user is described as being involved in "laboratory testing procedures", which is the environment where IVDs are used.
Therefore, based on the provided information, this device fits the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Liquichek: Cardiac Markers Plus Control, Cardiac Markers Plus Control LT and Cardiac Markers Plus Control LT Low are intended for use as a quality control serum to monitor the precision of laboratory testing procedures listed in the package insert.
Liquichek Cardiac Markers Plus Control is intended for use as aquality control serum to monitor the precision of laboratory testingprocedures listed in the package insert.
Liquichek Cardiac Markers Plus Control LT is intended for use as aquality control serum to monitor the precision of laboratory testingprocedures listed in the package insert.
Liquichek Cardiac Markers Plus Control LT Low is intended for useas a quality control serum to monitor the precision of laboratorytesting procedures listed in the package insert.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
These products are prepared from human serum with added constituents of human and animal origin, preservatives and stabilizers. These controls are provided in liquid form.
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
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Cardiac Markers Plus Control. Product claims are as follows:
- Open vial: All analytes will be stable for 20 days at 2 to 8°C. 8.1
- 8.2 Shelf Life: 3 years at -20°C to -70°C
- 8.3 Real time studies will be ongoing to support the shelf life of this product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Summary of Safety and Effectiveness Liquichek™ Cardiac Markers Plus Controls
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 Fax: (949) 598-1557
Contact Person
Suzanne S. Parsons Regulatory Affairs Specialist Telephone: (949) 598-1467
Date of Summary Preparation
February 16, 2005
2.0 Device Identification
| Product Trade Name: | Liquichek Cardiac Markers Plus Control |
|---|---|
| Liquichek Cardiac Markers Plus Control LT | |
| Liquichek Cardiac Markers Plus Control LT Low |
Common Name: Multi-Analyte Controls, all kinds (Assayed and Unassayed)
| Classifications: | Class I |
|---|---|
| Product Code: | JJY |
| Regulation Number: | CFR 862.1660 |
3.0 Device to Which Substantial Equivalence is Claimed
Liquichek™ Cardiac Markers Control LT Bio-Rad Laboratories Irvine, California
Docket Number: K040277
4.0 Description of Device
These products are prepared from human serum with added constituents of human and animal origin, preservatives and stabilizers. These controls are provided in liquid form.
5.0 Statement of Intended Use
- 6.0 Liquichek: Cardiac Markers Plus Control, Cardiac Markers Plus Control LT and Cardiac Markers Plus Control LT Low are intended for use as a quality control serum to monitor the precision of laboratory testing procedures listed in the package insert. These products do not contain sodium azide as a preservative. They contain a broad-spectrum anti-microbial cocktail as preservatives
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- where the concentration of any one ingredient is less than 0.1%. At this low level, these ingredients are not expected to cause a health hazard to the user. And thus, domestic and international regulations do not require this type of information on the vial or box label.
7.0 Comparison of the new device with the Predicate Device
Liquichek Cardiac Markers Plus Controls claims substantial equivalence to the Liquichek™ Cardiac Markers Control LT currently in commercial distribution. The new Liquichek Cardiac Markers Plus Controls contain B-type Natriuretic Peptide (BNP), Creatine Kinase, Total and C-Reactive Protein (CRP). The current product does not contain these analytes.
| Table 1. Similarities and Differences between new and predicate device. | |
|---|---|
| ------------------------------------------------------------------------- | -- |
| Characteristics | Bio-Rad
Liquichek™ Cardiac Markers Plus Controls
(New Device) | Bio-Rad
Liquichek™ Cardiac Markers Control LT
(Predicate Device K040277) |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
| Intended Use | Liquichek Cardiac Markers Plus Controls are intended for use
as a quality control serum to monitor the precision of laboratory
testing procedures listed in the package insert. | Liquichek Cardiac Markers Control LT is intended for use as
an assayed quality control serum to monitor the precision of
laboratory testing procedures listed in the package insert. |
| Form | Liquid | Liquid |
| Matrix | Human serum based | Human serum based |
| | Differences | |
| Storage
(Unopened) | -20°C to -70°C
Until expiration date | -20°C or colder
Until expiration date |
| Open Vial Claim | 20 days at 2-8°C | All analytes 10 days except NT-proBNP 5 days at 2-8°C |
| Analytes | Contains:
B-type Natriuretic Peptide (BNP)
Creatine Kinase, Total
C-Reactive Protein (CRP)
CK-MB Isoenzyme
Digitoxin
Homocysteine
Myoglobin
N-terminal pro-B-type Natriuretic Peptide (NT-pro BNP)
Troponin I
Troponin T | Contains:
CK-MB Isoenzyme
Digitoxin
Homocysteine
Myoglobin
N-terminal pro-B-type Natriuretic Peptide (NT-pro BNP)
Troponin I
Troponin T
Does not contain
B-type Natriuretic Peptide (BNP)
Creatine Kinase, Total
C-Reactive Protein (CRP) |
8.0 STATEMENT OF SUPPORTING DATA
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Cardiac Markers Plus Control. Product claims are as follows:
- Open vial: All analytes will be stable for 20 days at 2 to 8°C. 8.1
- 8.2 Shelf Life: 3 years at -20°C to -70°C
- 8.3 Real time studies will be ongoing to support the shelf life of this product.
All supporting data is retained on file at Bio-Rad Laboratories.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing the wings and head. The eagle is facing to the right.
APR 2 7 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Suzanne S. Parsons Regulatory Affairs Specialist Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K050537
Trade/Device Name: Liquichek™ Cardiac Markers Plus Control Liquchek™ Cardiac Markers Plus Control LT Liquichek™ Cardiac Markers Plus Control LT Low Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: February 22, 2005 Received: March 2, 2005
Dear Ms. Platt:
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 such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
Sean M. Coogen, MS, DVM
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K050537 |
|---|---|
| Device Name: | Liquichek™ Cardiac Markers Plus Control |
| Indications For Use: | Liquichek Cardiac Markers Plus Control is intended for use as aquality control serum to monitor the precision of laboratory testingprocedures listed in the package insert. |
| Device Name: | Liquichek™ Cardiac Markers Plus Control LT |
| Indications For Use: | Liquichek Cardiac Markers Plus Control LT is intended for use as aquality control serum to monitor the precision of laboratory testingprocedures listed in the package insert. |
| Device Name: | Liquichek™ Cardiac Markers Plus Control LT Low |
| Indications For Use: | Liquichek Cardiac Markers Plus Control LT Low is intended for useas a quality control serum to monitor the precision of laboratorytesting procedures listed in the package insert. |
Prescription Use_ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benson
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number _ 05705
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