(27 days)
EURO/DPC's TMC is an assayed, human serum-based, tri-level control containing several human source-derived analytes associated with malignancy which are commonly measured by immunoassay. It is intended strictly for in vitro diagnostic use as an aid in monitoring the day-to-day performance of assays for these constituents.
Quality Control Material
I am sorry, but the provided text does not contain information on acceptance criteria, device performance, clinical study details, or ground truth establishment. The document is a 510(k) summary for a "Tumor Marker Control Device," which is a quality control material, not a diagnostic device with performance metrics related to patient outcomes.
Therefore, I cannot populate the table or answer the questions related to clinical studies, human readers, or ground truth.
Here's what I can tell you based on the provided text:
- Device Name: Tumor Marker Control Device (Trade: TMC, Catalog Number: TMCO)
- Intended Use: "an aid in monitoring the day-to-day performance of assays for these constituents." (referring to analytes associated with malignancy)
- Clinical Studies: The document explicitly states "Not applicable" for clinical studies. This is expected for a quality control material, as its performance is evaluated against established assay values, not clinical outcomes.
Since there are no clinical studies or performance data against specific acceptance criteria for a diagnostic device, the requested information cannot be extracted from this document.
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AUG 1 2 1998
K9829473
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:
Sole U.S. Importer:
Establishment Registration #:
Description of Device:
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 15, 1998
Tumor Marker Control Device intended as an aid in monitoring the performance of DPC's tumor marker assays.
TMCO
Class I device, 75-JJY (21 CFR 862.1660)
EURO/DPC Ltd., a wholly-owned subsidiary of DPC Glyn Rhonwy Llanberis, Gwynedd LL55 4EL United Kingdom (Manufacturing under a Quality System-ISO 9002/EN29002/BS 5750)
Diagnostic Products Corporation (DPC) 5700 West 96th Street Los Angeles, CA 90045-5597
EURO/DPC: Not Applicable DPC: 2017183
Quality Control Material
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Intended Use of the Device:
EURO/DPC's TMC is an assayed, human serumbased, tri-level control containing several human source-derived analytes associated with malignancy which are commonly measured by immunoassay. It is intended strictly for in vitro diagnostic use as an aid in monitoring the day-to-day performance of assays for these constituents.
Clinical Studies:
Not applicable
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® Tumor Marker Controls.
Edward Garcia
Edward M. Levine, Ph.D. Director of Clinical Affairs
H15158
Date
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing a bird, which is meant to symbolize the department's mission of protecting the health of all Americans and providing essential human services.
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: K982473 Trade Name: Tumor Marker Control Module Requlatory Class: । Product Code: JJY Dated: July 15, 1998 Received: July 16, 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 leqally 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. Existinq major requlations 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 Reqister. 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 requlations.
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Page 2
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 leqally 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 labelinq regulation (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, "Misbrandinq 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 Butman
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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510(k) Number (if known): K96514- ____________________________________________________________________________________________________________________________________________
K065114 8782971
Device Name: IMMULITE® Tumor Marker Control
Indications For Use:
EURO/DPC's TMC is an assayed, human serum-based, tri-level control containing several human source-derived analytes associated with malignancy which are commonly measured by immunoassay. It is intended strictly for in vitro diagnostic use as an aid in monitoring the day-to-day performance of assays for these constituents.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Madlem
Division Sign-Off) 510ik) Num
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.