(7 days)
Abbott Liquid Lipids Chemistry Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the value sheet.
Not Found
This FDA 510(k) clearance letter dated January 26, 1999, for the "Abbott Liquid Lipids Chemistry Control" is a clearance for a quality control serum, not a diagnostic device with performance metrics that can be analyzed in the typical way for AI/ML device studies.
Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for AI algorithms is not applicable to this type of device and document.
Here's an explanation of why and what information can be gleaned:
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Device Type: This is a chemistry control solution, used to monitor the precision of laboratory testing procedures. It is essentially a substance with known (or assigned) concentrations of various analytes that is run on an analytical instrument to ensure the instrument is performing correctly. It does not produce a diagnosis or perform an analysis of patient data.
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Regulatory Focus: For this type of device, the FDA's review focuses on substantial equivalence to existing legally marketed predicate devices, ensuring that the control material itself is stable, reliable, and suitable for its intended purpose (monitoring precision) without introducing new safety or effectiveness concerns. The "acceptance criteria" here relate to the manufacturing and characterization of the control material rather than diagnostic performance metrics.
Information Applicable from the Document (or reasonably inferred based on device type):
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Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of diagnostic performance. For a chemistry control, acceptance criteria would typically involve:
- Analytes: The specific lipid analytes it controls (e.g., Cholesterol, Triglycerides, HDL, LDL as listed on a value sheet).
- Assigned Values/Ranges: The expected concentration values and acceptable ranges for each analyte when run on specified instruments, established through rigorous manufacturing and testing.
- Stability: The shelf-life and in-use stability of the control material.
- Homogeneity: Uniformity of the control material.
- Matrix Effects: Absence of interference with common analytical methods.
- Reported Device Performance: The document does not contain this. This would typically be in the 510(k) submission itself (which is not provided) and would demonstrate that the control material meets its claimed characteristics (e.g., assigned values are within established ranges, lot-to-lot variability is acceptable, stability data supports shelf-life claims).
- Acceptance Criteria: Not explicitly stated in terms of diagnostic performance. For a chemistry control, acceptance criteria would typically involve:
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Sample size used for the test set and the data provenance: Not applicable. There isn't a "test set" of patient data in the context of an AI algorithm. A manufacturer would perform internal testing during development and validation of the control material.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in this context would likely refer to the assigned values of the analytes in the control material, which are established through extensive analytical testing by qualified laboratory personnel, often in comparison to reference methods or reference materials.
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Adjudication method for the test set: Not applicable.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an AI/ML diagnostic device, so MRMC studies are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI algorithm.
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The type of ground truth used: For quality control materials, the "ground truth" (or accepted reference values) for the analytes within the control material are established through:
- Reference Methods and Materials: Comparison to international reference methods or certified reference materials with known traceability.
- Round-robin Studies: Testing by multiple independent qualified laboratories to establish consensus values.
- Manufacturer's Internal Validation: Rigorous analytical testing utilizing validated methods and calibrated equipment.
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The sample size for the training set: Not applicable. There is no AI training set for this device.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory clearance for a laboratory quality control product, not an AI/ML diagnostic device. Therefore, the questions designed for AI/ML performance evaluation are not relevant to this specific clearance letter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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JAN 26 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017
Re: K990150
Trade Name: Abbott Liquid Lipids Chemistry Control Regulatory Class: I Product Code: JJY Dated: January 13, 1999 Received: January 19, 1999
Dear Ms. Platt:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ragoneo 510(k) Number: Abbott Liquid Lipids Chemistry Control Device Name:
Indications for Use:
Abbott Liquid Lipids Chemistry Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the value sheet.
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
| Prescription Use | |
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| ------------------ | --------------------------------------------------------- |
| OR Over-The Counter Use | |
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| -- | ------------------------- |
| (Division Sign-Off) | |
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| Division of Clinical Laboratory Devices | |
| 510(k) Number | K990150 |
§ 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.