(49 days)
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No
The document describes a quality control material for chemistry tests, which is a consumable product and does not involve software or data processing in a way that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is described as an "assayed quality control material" for chemical constituents, indicating it is used for testing and measurement rather than treating a disease or condition.
No
The device is described as an "assayed quality control material" for testing constituents, not for diagnosing a disease or condition in a patient. It's used for quality control of other tests.
No
The 510(k) summary describes a liquid quality control material, which is a physical substance used in laboratory testing, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "quality control material for the constituents listed in this package insert." Quality control materials for chemical analysis of biological samples are a core component of in vitro diagnostics. They are used to verify the accuracy and precision of diagnostic tests performed outside of the body (in vitro).
While the "Device Description" is not found in the provided text, the "Intended Use" alone is sufficient to classify it as an IVD.
N/A
Intended Use / Indications for Use
CLINIQA® Liquid QC™ Assayed General Chemistry Control is intended for use as an assayed quality control material for the contituents listed in this package insert.
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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The eagle is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged around the border of the circle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Cliniqa Corporation c/o Ms. Carol Ruggiero Director of Regulatory Affairs 1432 South Mission Road Fallbrook, CA 92028
MAY - 4 2007
K070741 Re:
Trade Name: Cliniqa Liquid QC Assayed and Unassayed General Chemistry Control Levels 1, 2 & 3 Regulation Number: 21 CFR §862.1660 Quality control material (assayed and unassayed). Regulation Name: Regulatory Class: Class I (Reserved) Product Code: JJY Dated: March 08, 2007 Received: March 16, 2007
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 80.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollit the (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.
Yéan 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
Indications for Use
510(k) Number (if known): KO70 0 74
Device Name: CLINIQA Liquid QC Assayed General Chemistry Control, Levels 1, 2, & 3
Indications For Use:
CLINIQA® Liquid QC™ Assayed General Chemistry Control is intended for use as an assayed quality control material for the contituents listed in this package insert.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 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)
167
vision Sign-Off
office of In Vitro Diagnostic Device ustion and Safety
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