(28 days)
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No
The document describes quality control materials and calibrators for lipid analysis, which are chemical reagents and do not inherently involve AI/ML technology. There are no mentions of AI, ML, algorithms, or data processing in a way that suggests AI/ML is used.
No
The devices are described as quality control material, calibration verifiers, and calibrators for analysis and calibration of clinical chemistry analyzers, not for treating a disease or condition.
No
Explanation: The devices are described as quality control materials, calibration verifiers, and calibrators for analytical tests. They are used to evaluate the performance or calibrate analytical systems, not to directly diagnose a disease or condition in a patient.
No
The provided text describes liquid quality control materials and calibrators for laboratory analysis, which are physical substances, not software.
Based on the provided information, yes, these devices are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use statements clearly indicate that these products are designed to be used in vitro (outside the body) for the analysis of biological samples (specifically, for measuring lipids like cholesterol, triglycerides, and apolipoproteins).
- Purpose: They are used for quality control, calibration verification, and calibration of analytical methods used in clinical chemistry analyzers. These are all essential functions within the realm of in vitro diagnostic testing.
The descriptions explicitly state their purpose in relation to laboratory analysis of biological samples, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
CLINIQA Liquid QC Lipid Controls Levels 1 and 2 are intended for use as assayed quality control material for Apolipoprotein A-1, Apolipoprotein B, Cholesterol (total), High Density Lipoprotein, Low Density Lipoprotein and Triglyceride analysis.
CLINIQA LiniCAL Lipid Calibration Verifiers Levels A - E for Olympus AU Systems are assayed, liquid, quality control products which may be used to evaluate the performance of the Olympus AU Systems for Cholesterol (total), High Density Lipoprotein. Low Density Lipoprotein and Triglyceride at five useful concentrations.
CLINIQA QALIBRATE™ - Lipid Calibrator is intended for use in assay method calibration for clinical chemistry analyzers listed in the product insert.
Product codes
JJY, JIX
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)
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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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's emblem, which is a stylized representation of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 5 2006
Ms. Carol Ruggiero Director of Regulatory Affairs Cliniqa Corporation 1432 South Mission Road Fallbrook, CA 92028
K061182 Re:
Trade/Device Name: CLINIQA® Liquid QC™ Lipid Controls Levels 1 and 2 CLINIQA® LiniCAL® Lipid Calibration Verifiers Levels A-E for Olympus CLINIQA® QALIBRATE™ - Lipid Calibrator Regulation Number: 21 CFR§ 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JJY, JIX Dated: April 25, 2006 Received: April 27, 2006
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) 276-0484. 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 yours,
Alberto G. A.
Alberto Gutierrez, Ph.D. 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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510(k) Number (if known): KOGl (82
Device Name: CLINIQA® Liquid QC™ Lipid Controls Levels 1 and 2
Indications For Use:
CLINIQA Liquid QC Lipid Controls Levels 1 and 2 are intended for use as assayed quality control material for Apolipoprotein A-1, Apolipoprotein B, Cholesterol (total), High Density Lipoprotein, Low Density Lipoprotein and Triglyceride analysis.
510(k) Number (if known):
Device Name: CLINIQA® Lipid Calibration Verifiers Levels A - E for Olympus AU Systems
Indications For Use:
CLINIQA LiniCAL Lipid Calibration Verifiers Levels A - E for Olympus AU Systems are assayed, liquid, quality control products which may be used to evaluate the performance of the Olympus AU Systems for Cholesterol (total), High Density Lipoprotein. Low Density Lipoprotein and Triglyceride at five useful concentrations.
510(k) Number (if known):
Device Name: CLINIQA QALIBRATE™ - Lipid Calibrator
Indications For Use:
CLINIQA QALIBRATE™ - Lipid Calibrator is intended for use in assay method calibration for clinical chemistry analyzers listed in the product insert.
Prescription Use _ X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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) Bivision Sign-Off exem
Cillia > of In Vitro Diagnostic Devery Evaluation and Safety