(14 days)
IMMULITE® PSA Control Module Device intended as an aid in monitoring the DPC's and performance of of IMMULITE IMMULITE 2000 PSA assays.
IMMULITE PSA Control Module is an assayed, tri-level control intended for use with the IMMULITE PSA and IMMULITE 2000 PSA assays. It is intended as an aid in monitoring dayto-day assay performance.
Quality Control Material
The provided text is a 510(k) summary for the IMMULITE® PSA Control Module, a quality control material. It does not contain information about acceptance criteria or a study proving performance for a device intended for clinical diagnosis in the way a typical AI/ML device would.
The document states:
- Device Name: IMMULITE® PSA Control Module
- Intended Use: An assayed, tri-level control intended for use with the IMMULITE PSA and IMMULITE 2000 PSA assays. It is intended as an aid in monitoring day-to-day assay performance.
- Clinical Studies: "Not applicable"
Therefore, I cannot extract the specific information requested in your numbered list for an AI/ML device's performance study because the document is about a quality control material, not a diagnostic device that requires such performance criteria and studies. The "study" mentioned is the FDA's review of the 510(k) submission to establish substantial equivalence to a predicate device, not a clinical trial demonstrating diagnostic accuracy.
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16982637
AUG 1 2 1998
510 (k) Summary Safety and Effectiveness
This summary of safety and effectiveness information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
Name: Address:
Telephone Number: Facsimile Number:
Contact Person:
Date of Preparation:
Device Name: Trade:
Catalog Number:
Classification:
Manufacturer:
Establishment Registration #:
Description of Device:
Intended Use of the Device:
Clinical Studies:
Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597
(213) 776-0180 (213) 776-0204
Edward M. Levine, Ph.D. Director of Clinical Affairs
July 28, 1998
IMMULITE® PSA Control Module Device intended as an aid in monitoring the DPC's and performance of of IMMULITE IMMULITE 2000 PSA assays.
LPSCM
Class I device, 75-JJY (21 CFR 862.1660)
Diagnostic Products Corporation (DPC) 5700 West 96th Street Los Angeles, CA 90045-5597
2017183
Quality Control Material
IMMULITE PSA Control Module is an assayed, tri-level control intended for use with the IMMULITE PSA and IMMULITE 2000 PSA assays. It is intended as an aid in monitoring dayto-day assay performance.
Not applicable
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Conclusion:
The data presented in this summary of safety and effectiveness is the data that the Food and Drug
Administration used in granting DPC substantial equivalence for IMMULITE® PS Module.
Edward M. Levin, Ph.D.
Edward M. Levine, Ph.D. Director of Clinical Affairs
7/28/58
Date
Date
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Public Health Service
Image /page/2/Picture/2 description: The image shows a partial logo of the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with healthcare, with three lines representing the serpent and staff. The word "DEPARTMENT" is partially visible, running vertically along the left side of the image.
AUG 1 2 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Edward M. Levine, Ph.D. Director of Clinical Affairs Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597
Re : K982637 Trade Name: IMMULITE® PSA Control Module Requlatory Class: I Product Code: JJY Dated: July 28, 1998 Received: July 29, 1998
Dear Dr. Levine:
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, qood 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 Toutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
§ 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.