(53 days)
Not Found.
Not Found
No
The summary describes a chemical assay for measuring LDL cholesterol and does not mention any AI or ML components.
No
The device is an in vitro diagnostic reagent used to determine LDL Cholesterol levels, which aids in therapies but is not a therapy itself.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "The Randox Laboratories Limited Direct LDL Cholesterol Test Kit is an in vitro diagnostic reagent".
No
The device is described as an "in vitro diagnostic reagent" and a "Test Kit," which are physical components used in laboratory testing, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The Randox Laboratories Limited Direct LDL Cholesterol Test Kit is an in vitro diagnostic reagent for use in the quantitative determination of LDL Cholesterol in serum and plasma."
This statement clearly identifies the device as an in vitro diagnostic reagent.
N/A
Intended Use / Indications for Use
The Randox Laboratories Limited Direct LDL Cholesterol Test Kit is an in vitro diagnostic reagent for use in the quantitative determination of LDL Cholesterol in serum and plasma. The method, an elimination enzymatic assay, does not require any sample preparation.
Accurate measurement of LDL Cholesterol is of vital importance in therapies that focus on lipid reduction to prevent atherosclerosis or reduce its progress.
Suitably qualified laboratory personnel under appropriate laboratory conditions must use this Test Kit.
Product codes
MRR
Device Description
Not Found.
Mentions image processing
Not Found.
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Not Found.
Anatomical Site
Not Found.
Indicated Patient Age Range
Not Found.
Intended User / Care Setting
Suitably qualified laboratory personnel under appropriate laboratory conditions.
Description of the training set, sample size, data source, and annotation protocol
Not Found.
Description of the test set, sample size, data source, and annotation protocol
Not Found.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found.
Predicate Device(s)
Not Found.
Reference Device(s)
Not Found.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found.
§ 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.
0
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 1 1998
Dr. P. Armstrong . Requlatory Affairs Randox Laboratories, Ltd. Ardmore, Diamond Road Crumlin, Co. Antrim, United Kingdom, BT29 4QY
K982529 Re : Direct LDL Cholesterol Test Kit Requlatory Class: I Product Code: MRR Dated: July 17, 1998 Received: July 20, 1998 . .
Dear Dr. Armstrong:
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 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 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/dsmamain.html" .
Sincerely yours,
Steven Gutman
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
2
5983529 510(k) Number (if known)
Device Name DIRECT LDL - CHOLESTEROL
Indications For Use :
The Randox Laboratories Limited Direct LDL Cholesterol Test Kit is an in vitro diagnostic reagent for use in the quantitative determination of LDL Cholesterol in serum and plasma. The method, an elimination enzymatic assay, does not require any sample preparation.
Accurate measurement of LDL Cholesterol is of vital importance in therapies that focus on lipid reduction to prevent atherosclerosis or reduce its progress.
Suitably qualified laboratory personnel under appropriate laboratory conditions must use this Test Kit.
(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. K983090