(27 days)
This product is to be used as a quantitative control in the determination of cholesterol content of high density lipoproteins (HDL) and low density lipoproteins (LDL) using the REP agarose electrophoresis system.
Not Found
This is a 510(k) clearance letter for a control solution, explicitly stating that it's for "quantitative control in the determination of cholesterol content of high density lipoproteins (HDL) and low density lipoproteins (LDL) using the REP agarose electrophoresis system."
The letter does not contain the kind of detailed study information (acceptance criteria, performance data, sample sizes, expert qualifications, etc.) that would typically be found in a Premarket Approval (PMA) application or a more detailed submission for a diagnostic device.
Therefore, I cannot provide the requested information from the provided text.
Here's why:
- Device Type: This is a control solution, used to verify the performance of a cholesterol measurement system, not the measurement system itself. The FDA clearance is based on its substantial equivalence as a laboratory control, not on its diagnostic accuracy in patients.
- 510(k) vs. PMA: A 510(k) submission primarily demonstrates "substantial equivalence" to a predicate device. While some data is required, it generally doesn't involve the extensive clinical trial data and detailed performance analysis (including specific acceptance criteria, ground truth establishment, expert adjudication, etc.) that would be necessary for a de novo classification or a PMA. The detailed performance studies would typically be conducted for the measurement system (the REP agarose electrophoresis system), not necessarily for the control itself beyond its stability and correct value assignment.
To get the information you're asking for, you would need documentation related to the performance studies of the REP agarose electrophoresis system, not the REP Cholesterol Profile Control-II.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Pat Franks Helena Laboratories 1530 Lindbergh Drive P.O. Box 752 Beaumont, Texas 77704-0752
JAN - 6 1998
Re : K974609 REP Cholesterol Profile Control-II Requlatory Class: I Product Code: JJX December 8, 1997 Dated: Received: December 10, 1997
Dear Ms. Franks:
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, Druq, 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, 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. ಗ 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 requlation 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 (chin oo), chip dovice map aquin 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 marroos problems, 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 ene regulation Chercica, "Increanon.g7) 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 Sitman
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):
REP Cholesterol Control-II pevice Name:
Indications for Use:
ານເລືອກັບປະຊາທິປະຈຸບັນດາວ
This product is to be used as a quantitative control in the determination of cholesterol content of high density lipoproteins (HDL) and low density lipoproteins (LDL) using the REP agarose electrophoresis system.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF 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)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. 984609
§ 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.