(15 days)
Clinical laboratories, performing immunoassays for drugs, hormones and proteins on automated immunoassay systems may use Qualitrol Immunoassay DHP Control or CONFORMANCE MCC-Ligand Control routinely as a means of estimating precision and monitoring test system performance, provided:
(a) the above mentioned controls, provided as a set (Levels 1, 2 3) are used as an adjunct to primary control procedure and recommended by the manufacturer of immunoassay systems.
(b) above mentioned controls are used in accordance with the quality control requirements of regulatory and/or accrediting organizations and laboratory's quality control goals;
(c ) above mentioned controls are validated for use with the specific immunoassay test system being used by the clinical laboratory.
These controls have been assayed with AxSYM, IMx and TDX systems manufactured by Abbott Laboratories (Abbott Park, USA). The expected values, for these systems, are included in the package insert. The controls may be used as assayed controls for the stated indication for use when measurements are made with above-mentioned immunoassay systems.
Not Found
This is an FDA Premarket Notification (510k) letter for a device called "Qualitrol DHP Immunoassay Control Levels 1, 2, and 3". As such, the purpose of this document is to establish substantial equivalence to a predicate device, not to present a study proving the device meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity. There is no information provided in this document that would allow for the completion of the requested table and study details.
The letter explicitly states: "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 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)."
The "Indication for Use" section describes how the control solution should be used (e.g., as an adjunct to primary control procedures, in accordance with quality control requirements, and validated for the specific immunoassay system). It also mentions that the controls have been assayed with specific immunoassay systems (AxSYM, IMx, and TDX systems manufactured by Abbott Laboratories) and that expected values are included in the package insert. However, this does not constitute a study with acceptance criteria and performance metrics for the control device itself in the way typically expected for a diagnostic or AI-enabled device.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets those criteria, as this information is not present in the provided document.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 18 1997
Vipin D. Shah
· Chief Operating Officer Consolidated Technologies, Inc. 2170 Woodward Street Austin, Texas 78744-1832
K972080 Re: Qualitrol DHP Immunoassay Control Levels 1, 2, and 3 Regulatory Class: I Product Code: JJY Dated: May 31, 1997 Received: June 3, 1997
Dear Mr. Shah:
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 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 reqistration, 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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/dsmamain.html".
sincerely yours,
Steven Litman
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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INDICATION FOR USE
Device Name: Qualitrol DHP Immunoassay Control CONFORMANCE MCC-Ligand Control
Indication for Use: Clinical laboratories, performing immunoassays for drugs, hormones and proteins on automated immunoassay systems may use Qualitrol Immunoassay DHP Control or CONFORMANCE MCC-Ligand Control routinely as a means of estimating precision and monitoring test system performance, provided:
(a) the above mentioned controls, provided as a set (Levels 1, 2 3) are used as an adjunct to primary control procedure and recommended by the manufacturer of immunoassay systems.
(b) above mentioned controls are used in accordance with the quality control requirements of regulatory and/or accrediting organizations and laboratory's quality control goals;
(c ) above mentioned controls are validated for use with the specific immunoassay test system being used by the clinical laboratory.
These controls have been assayed with AxSYM, IMx and TDX systems manufactured by Abbott Laboratories (Abbott Park, USA). The expected values, for these systems, are included in the package insert. The controls may be used as assayed controls for the stated indication for use when measurements are made with above-mentioned immunoassay systems.
Aller) City
(Division Sign Off)
Division of Clinical Laboratory Devic
510(k) Number 2972080
CICF +1x (cui
§ 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.