(59 days)
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No
The document describes quality control and calibration materials for cardiac markers, which are standard laboratory reagents and do not involve AI/ML technology. There are no mentions of AI, ML, image processing, or data analysis methods that would suggest the use of such technologies.
No.
The device is described as quality control material and calibration verifiers for cardiac markers, intended for use in a clinical laboratory to monitor and verify analyzer performance, not to directly treat or diagnose patients.
No
Explanation: The device is described as quality control material and calibration verifiers for cardiac markers, used to verify calibration and assess linearity of analyzers. It is not intended for the direct diagnosis of a condition in a patient.
No
The device description and intended use clearly indicate this is a liquid quality control material and calibration verifier, which are physical substances, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the products are for use in the clinical laboratory as quality control material and calibration verifiers for cardiac markers. These are all activities performed in vitro (outside the body) on biological samples to provide information for diagnosis or monitoring.
- Device Description (though not found): While the description is missing, the intended use strongly indicates the nature of the device. Quality control materials and calibration verifiers for laboratory tests are inherently IVDs.
- Intended User / Care Setting: The intended user is the clinical laboratory, which is the typical setting for performing in vitro diagnostic tests.
The fact that it's used for quality control and calibration in a clinical laboratory setting for cardiac markers definitively places it within the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
CLINIQA® Liquid QC™ Complete Cardiac Marker Control Levels 1, 2, and 3 is intended for use as an assayed quality control material for cardiac markers listed in the product insert. CLINIQA Liquid QC Complete Cardiac Marker Control is not intended for uroud a standard.
LiniCAL Cardiac Marker Calibration Verifiers are intended for use in the clinical laboratory to verify calibration and/or assess linearity of the analyzers listed in the product insert. Four assayed levels of analytes listed in the product inert are provided to allow monitoring of the reportable range.
CLINIQA Liquid QC Cardiac Marker Controls, Low is intended for use as an assayed quality control material for cardiac markers listed in the product insert. CLINIQA Liguid QC Complete Cardiac Marker Control is not intended for use as a standard.
Product codes
JJY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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.
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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.
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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).
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§ 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
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" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
CLINIOA Corp. c/o Ms. Carol Ruggiero Director of Regulatory Affairs 774 North Twin Oaks Valley Road San Marcos, CA 92069
JUN - 2 2008
Re: K080973
Trade Name: Cliniqa Liquid QC Complete Cardiac Marker Control, Levels 1, 2, and 3, Cliniqa LiniCal Cardiac Marker Calibration Verifiers, Levels A-D, Cliniqa Liquid QC Cardiac Marker Control-Low Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I (reserved) Product Code: JJY Dated: April 03, 2008 Received: April 04, 2008
Dear Ms. Ruggiero:
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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.v.M.
Yean M. Cooper, M.S., 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
2
510(k) Number (if known):
Device Name: CLINIQA Liquid QC Complete Cardiac Marker Control, Levels 1, 2, and 3
Indications For Use:
CLINIQA® Liquid QC™ Complete Cardiac Marker Control Levels 1, 2, and 3 is intended for use as an assayed quality control material for cardiac markers listed in the product insert. CLINIQA Liquid QC Complete Cardiac Marker Control is not intended for uroud a standard.
Device Name: CLINIQA LiniCAL Cardiac Marker Calibration Verifiers, Levels A-D
Indications For Use:
LiniCAL Cardiac Marker Calibration Verifiers are intended for use in the clinical laboratory to verify calibration and/or assess linearity of the analyzers listed in the product insert. Four assayed levels of analytes listed in the product inert are provided to allow monitoring of the
reportable range.
Device Name: CLINIQA Liquid QC Cardiac Marker Control - Low
Indications For Use:
CLINIQA Liquid QC Cardiac Marker Controls, Low is intended for use as an assayed quality control material for cardiac markers listed in the product insert. CLINIQA Liguid QC Complete Cardiac Marker Control is not intended for use as a standard.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Carol C. Benson
Sign-Off
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rrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)