(22 days)
For the calibration of in-vitro diagnostic methods for the direct quantitative determination of HDL Cholesterol and LDL Cholesterol in serum.
DMA's HDL Cholesterol and LDL Cholesterol calibrator is intended for the calibration of in-vitro diagnostic methods for the direct quantitative determination of HDLC and LDLC in serum.
The provided document is a 510(k) summary for a medical device called "DMA HDL Cholesterol and LDL Cholesterol Calibrator." It describes the device's intended use and technological characteristics in comparison to a predicate device. However, this document does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes (for training or test sets), expert qualifications, or ground truth establishment relevant to the device's performance.
The document is a regulatory submission summarizing the device's purpose and its substantial equivalence to a predicate device for FDA clearance. It does not include the actual study data or the detailed acceptance criteria and performance results that would be part of a full study report.
Therefore, I cannot provide the requested information from this document.
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Image /page/0/Picture/0 description: The image shows the date October 8, 1999. The month is abbreviated as OCT. The numbers are clearly visible and easy to read.
Image /page/0/Picture/1 description: The image shows the logo for DMA, which is a black and white image. The letters "DMA" are in a bold, sans-serif font, with the "M" being the largest letter. There is a registered trademark symbol to the right of the letter A. The logo is simple and modern.
Customer Service & Tech Support 800/558-9115 mo BioAnalysis Corporation, a Thermo Electron company 817/640-0965 FAX 817/649-2461 ww.dma-inc.com
510 K Summary
This Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990 AND 21 CFR 807.92
Submitter: Data Medical Associates, Incorporated (DMA) Contact Person: Thomas Dollar, Manager of Regulatory Affairs
The assigned 510(k) number is ( 99 309 8
Device: HDL Cholesterol and LDL Cholesterol Calibrator JIT Secondary Calibrator
Class: II
Predicate Device: HDL Cholesterol and LDL Cholesterol Calibrator, Reference Diagnostics Inc. Bedford, MA
Description and Intended Use: DMA's HDL Cholesterol and LDL Cholesterol calibrator is intended for the calibration of in-vitro diagnostic methods for the direct quantitative determination of HDLC and LDLC in serum.
Technological Characteristics: Both DMA and Reference Diagnostics are used for the determination of HDL Cholesterol and LDL Cholesterol in serum.
Date Prepared: 08/31/99
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with three faces in profile, overlaid with three curved lines that resemble flowing hair or fabric. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
8 1999 OCT
Mr. Thomas Dollar Manager of Regulatory Affairs Data Medical Associates, Inc. 845 Avenue G East Arlington, Texas 76011-7709
Re: · K993098
Trade Name: DMA HDL-C/LDL-C Calibrator Regulatory Class: II Product Code: JIX Dated: September 13, 1999 Received: September 16, 1999
Dear Mr. Dollar:
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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Image /page/3/Picture/0 description: The image shows a logo with the letters "DMA" in a bold, sans-serif font. The letters are arranged horizontally, with the "D" on the left, the "M" in the center, and the "A" on the right. The letters are black, and the background is white. There is a registered trademark symbol to the right of the letter A.
DATA MEDICAL ASSOCIATES, INC. A subsidiary of Thermo BioAnalysis Corporation, a Thermo Electron company 845 AVENUE G EAST ARLINGTON, TEXAS 76011-7709 USA
Customer Service & Tech Support 800/558-9115 817/640-0965 FAX 817/649-2461 www.dma-inc.com
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K993098
Device Name: DMA HDL-C/LDL-C Calibrator
Indications For Use: For the calibration of in-vitro diagnostic methods for the direct quantitative determination of HDL Cholesterol and LDL Cholesterol in serum.
Jean Cooper
(Division Sign-Off)
Division of Clinical Labat
510(k) Number K993096
/ Rx
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.