(28 days)
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.
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Here's an analysis of the provided text regarding the acceptance criteria and study for the CLINIQA® Liquid QC™ Lipid Controls, CLINIQA® LiniCAL® Lipid Calibration Verifiers, and CLINIQA® QALIBRATE™ - Lipid Calibrator.
It's important to note that the provided document is a 510(k) clearance letter from the FDA. This letter confirms that the devices are "substantially equivalent" to legally marketed predicate devices, meaning they have similar technology and intended use, and are deemed safe and effective. However, this document does not contain the detailed study report or specific acceptance criteria and performance data in the format typically used for AI/ML device evaluations. It primarily focuses on regulatory approval based on the substantial equivalence principle.
Therefore, much of the requested information (like specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, effect sizes, etc.) is not present in this regulatory letter.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not explicitly stated in the provided document. The 510(k) letter confirms that the devices are substantially equivalent to predicate devices, implying that their performance aligns with acceptable standards for their intended use. However, the specific quantitative acceptance criteria (e.g., precision, accuracy ranges) and the detailed study results meeting those criteria are not provided.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not available in the provided document. The 510(k) letter does not detail the specific studies (e.g., analytical performance studies) used to demonstrate substantial equivalence, nor does it specify the sample sizes or data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable/not available. These devices are "Calibrators" and "Quality Controls" for laboratory assays (Apolipoprotein A-1, Apolipoprotein B, Cholesterol, HDL, LDL, Triglyceride). The "ground truth" for such devices typically refers to their assigned values, which are established through rigorous analytical methods using reference materials and validated measurement procedures, not through expert consensus in the way a diagnostic imaging AI would. Therefore, the concept of "experts establishing ground truth" in this context is different and not described in the letter.
4. Adjudication Method for the Test Set:
This information is not applicable/not available for the reasons stated above in point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
This information is not applicable and not available. These devices are not AI/ML algorithms designed to assist human readers in interpreting medical images or data. They are in-vitro diagnostic products for calibrating and controlling laboratory assays. Therefore, MRMC studies and "human reader improvement with AI" are not relevant to these products.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done:
This information is not applicable and not available. These are not AI/ML algorithms, so the concept of standalone performance does not apply. Their performance is assessed through analytical validation studies (e.g., accuracy, precision, linearity) in a laboratory setting.
7. The Type of Ground Truth Used:
For these types of devices (calibrators and quality controls), the "ground truth" generally refers to:
- Assigned Values: The known, predetermined concentration or activity of the analytes within the calibrator or control solutions. These values are established by the manufacturer using highly accurate and precise reference methods, often traceable to international reference materials.
- Reference Methods: The established, gold-standard laboratory methods used to determine the assigned values of the control and calibrator materials.
The document does not detail how Cliniqa established these assigned values, but it's implicit that they followed standard practices for in vitro diagnostic product manufacturing and validation.
8. The Sample Size for the Training Set:
This information is not applicable/not available. These products are not AI/ML models that require "training sets." They are reagents with specific chemical compositions and assigned values.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/not available for the reasons stated in point 8.
Summary regarding the provided document:
The provided FDA 510(k) clearance letter serves as regulatory approval, indicating that the CLINIQA® Lipid products are substantially equivalent to existing marketed devices. It does not present a detailed study report with the specific performance acceptance criteria or study results that would typically be required for an AI/ML device. The nature of these devices (calibrators and quality controls) is fundamentally different from AI/ML diagnostic tools, hence many of the requested categories are not applicable.
To obtain the detailed performance data, one would typically need to refer to:
- The manufacturer's specific product inserts.
- Validation reports submitted to the FDA (which are not publicly detailed in the 510(k) summary letter).
- Peer-reviewed publications or internal validation studies conducted by the manufacturer.
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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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Page 2 -
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
§ 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.