(60 days)
Foe the quantitative determination of HDL-Cholesterol in scrum. For IN VITRO diagnostic use.
The procedure for HDL-Cholesterol precipitation in this formulation is a modification of the Burnstein and Samaille (2) method and uses phosphotungstate and magnesium ions to precipitate the LDL and VLDL fractions.
The provided text is a 510(k) premarket notification approval letter for a medical device called "HDL Uni-Paks (PTA)." This document does not contain acceptance criteria or a detailed study description that proves the device meets specific performance metrics.
Instead, this letter from the FDA confirms that the device is "substantially equivalent" to a legally marketed predicate device, allowing it to be marketed. The letter mentions that the manufacturer's 510(k) submission includes information that the FDA reviewed, but the submission itself is not provided here.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth method, etc.) from the given text.
The text only states:
- Device Name: HDL Uni-Paks (PTA), Catalogue Number 215-51
- Intended Use: For the quantitative determination of HDL-Cholesterol in serum. For IN VITRO diagnostic use.
- Mechanism: Uses phosphotungstate and magnesium ions to selectively precipitate VLDL and LDL fractions, leaving HDL in the supernatant for cholesterol concentration assay. It's a modification of the Burnstein and Samaille method.
- Regulatory Class: I
- Product Code: LBR
- 510(k) Number: K980770
To answer your questions, one would need to refer to the actual 510(k) submission document (K980770) from Diagnostic Chemicals Limited, which would contain the performance data and the studies conducted to demonstrate substantial equivalence to the predicate device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles facing to the right.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 21 1998
Karen Callbeck, R.T.B.Sc. Regulatory Affairs Coordinator Diagnostic Chemicals Limited West Royalty Industrial Park Charlottetown, PE Canada C1E, 1B0
Re : K980770 HDL Uni-Paks (PTA), Catalogue Number 215-51 Requlatory Class: I Product Code: LBR February 17, 1998 Dated: Received: February 20, 1998
Dear Ms. Callbeck:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 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 Regulation (QS) for Medical Devices: General requlation (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 In addition, FDA may publish further announcements action. 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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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 qeneral 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: __ HDL_UNI-PAKS (PTA)
Indications For Use:
Cat. No./Ref./Ref.No: 215-51 (100 tubes)
Foe the quantitative determination of HDL-Cholesterol in scrum.
For IN VITRO diagnostic use.
Barr, et.al. (1) in 1951 first reported the inverse relationship between high density lipoproteins (HDL) and coronary heart disease. Since that time, several procedures have been used to separate HDL including ultracentrifugation, electrophoresis, and precipitation. With the precipitation methods (heparin/manganese, dextran sulfate/magnesium, phosphotungstate/magnesium, and polyethylene glycol), the very low density lipoproteins (VLDL) and the low density lipoproteins (LDL) are first selectively precipitated and then the supernatant containing HDL is removed. Cholesterol concentration in the supernatant is then assayed to determine HDL-Cholesterol concentration using an enzymatic total cholesterol procedure. The procedure for HDL-Cholesterol precipitation in this formulation is a modification of the Burnstein and Samaille (2) method and uses phosphotungstate and magnesium ions to precipitate the LDL and VLDL fractions.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
§10(k) Number. 98070
Prescription Use _ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)
. `
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.