(37 days)
For the calibration of test systems for the measurement of HDL and LDL Cholesterol in human serum or plasma.
The Boehringer Mannheim c.f.a.s. - HDL/LDL-C plus calibrator consists of lyophilized human serum with added HDL-Cholesterol and LDL-Cholesterol.
The provided text is a 510(k) Summary for a medical device, specifically a calibrator used in diagnostic tests for HDL and LDL cholesterol. This type of document is for regulatory clearance and does not typically include detailed study results, acceptance criteria, or performance metrics in the way a clinical study report would.
Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving the device meets those criteria.
The 510(k) Summary focuses on demonstrating "substantial equivalence" to a predicate device, not on presenting novel performance data from a clinical trial with acceptance criteria. It states:
- "The Boehringer Mannheim Direct LDL-Cholesterol test is substantially equivalent to other products in commercial distribution intended for similar use."
- "The intended use of this BM calibrator and the predicate devices is the same..."
For this type of device (a calibrator), the "performance" demonstrated for regulatory clearance would likely involve analytical studies confirming its accuracy, precision, and stability as a calibrator, ensuring it produces expected values when used with compatible test systems. However, these specific details are not present in the provided text.
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JAN 30 1998
K974825
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
|---|---|
| 1) Submittername, address,contact | Boehringer Mannheim Corporation9115 Hague RdIndianapolis, IN 46250(317) 845-2386 |
| Contact person: Edward R. Kimmelman | |
| Date prepared: Dec. 23, 1997 | |
| 2) Device name | |
| Common name: c.f.a.s.- HDL/LDL-C | |
| Classification name: Calibrator, Multi-analyte mixture | |
| 3) Predicatedevice | We claim substantial equivalence to the Equal Diagnostics LDL DirectLiquid Select™ Cholesterol Calibrator and the Equal Diagnostics HDL DirectLiquid Select™ Cholesterol Calibrator. The intended use of the abovecalibrators is the establishment of calibration curves for their respective testsystems. |
| 4) Devicedescription | The Boehringer Mannheim c.f.a.s. - HDL/LDL-C plus calibrator consists oflyophilized human serum with added HDL-Cholesterol and LDL-Cholesterol. |
| 5) Intended use | The Boehringer Mannheim c.f.a.s. - HDL/LDL-C plus is intended to be usedin the calibration of test systems for the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) and low-density lipoproteinCholesterol (LDL-C) in serum and plasma. |
Continued on next page
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510(k) Summary, Continued
- Comparison to the predicate device
The Boehringer Mannheim Direct LDL-Cholesterol test is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Equal Diagnostics HDL Direct Liquid Select™ Cholesterol Calibrator and the Equal Diagnostics LDL Direct Liquid Select™ Cholesterol Calibrator.
The intended use of this BM calibrator and the predicate devices is the same in that they are intended to be used for the calibration of test systems for the measurement of their labeled analytes.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 30 1998
Edward R. Kimmelman . Program Director, Requlatory Affairs and Compliance Boehringer Mannheim Corporation 9115 Haque Road Indianapolis, Indiana 46250
Re : K974825 Boehringer Mannheim Calibrator for Automated Systems -HDL/LDL-C-PLUS Regulatory Class: II Product Code: JIX Dated: December 16, 1997 Received: December 24, 1997
Dear Mr. Kimmelman:
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 registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.com armann
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 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 requlatory 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 regulations.
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Page 2
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/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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510(k) Number (if known):
Device Name: Boehringer Mannheim Calibrator for Automated Systems -HDL/LDL-C plus
Indications for Use: For the calibration of test systems for the measurement of HDL and LDL Cholesterol in human serum or plasma.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED) .............................................................................................................................................................................. Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional format 1-2-96)
(DiDivision Sign-Off)
DivDivision of Clinical Laboratory Devices
510510(k) Number. 12974825
§ 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.