(143 days)
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Not Found
No
The description details a traditional electrophoresis and enzymatic method for quantifying cholesterol fractions, with visual interpretation and densitometry. There is no mention of AI or ML in the intended use or device description.
No
The device is used for in-vitro diagnostic quantification of cholesterol in lipoprotein fractions, not for treating or preventing diseases.
Yes
The device is designed for the quantification of cholesterol carried by LDL and HDL lipoprotein fractions, which is used for diagnostic purposes, such as measuring LDL/HDL cholesterol levels and their ratio.
No
The device description, while not explicitly provided, details a kit for laboratory analysis involving electrophoresis on agarose gel, visualization of lipoprotein fractions using enzymatic methods, and densitometry. This clearly involves physical reagents, gels, and potentially electrophoresis apparatus, indicating it is not a software-only device.
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The text explicitly states the kits are "designed for quantification of the cholesterol carried by the LDL and HDL lipoprotein fractions of human plasma or serum." This involves analyzing a biological sample (plasma or serum) outside of the body to obtain diagnostic information.
- Diagnostic Purpose: The procedure is indicated for "a direct measurement of: - the LDL cholesterol level... - the HDL cholesterol level - the ratio LDL/HDL cholesterol." These measurements are used in clinical settings to assess cardiovascular risk and diagnose related conditions.
- Clinical Laboratory Use: The intended user is a "Clinical Laboratory," which is a typical setting for IVD testing.
- Methodology: The process involves electrophoresis and enzymatic reactions on a biological sample, which are common techniques used in IVD assays.
The description clearly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
HYDRAGEL LDL/HDL CHOL DIRECT, HYDRAGEL 7 LDL/HDL CHOL DIRECT and HYDRAGEL LDL/HDL CHOL DIRECT 15/30 kits are designed for quantification of the cholesterol carried by the LDL and HDL lipoprotein fractions of human plasma or serum. The analysis is performed in two stages:
· electrophoresis on agarose gel to separate the VLDL, LDL and HDL as well as chylomicrons and Lp (a) when present,
· visualization of lipoprotein fractions based on a sensitive and cholesterol-specific enzymatic method involving cholesterol esterase and cholesterol oxidase, and a chromogenic system with reduced AEC (amino ethyl carbazole) and peroxidase.
The stained electrophoregrams are intended for visual interpretation to confirm identification of the individual fractions and for densitometry to obtain accurate, relative concentrations of cholesterol in the individual lipoprotein fractions If the sample's total cholesterol value is known, cholesterol distribution in g/dL or mol/L concentrations can be calculated. Since the LDL cholesterol and HDL cholesterol assays are of primary interest, laboratories may chose to measure the relative concentration of cholesterol only in the HDL and LDL fractions.
The procedure is indicated for the general population for a direct measurement of:
- the LDL cholesterol level regardless the triglyceride levels
- . the HDL cholesterol level
- the ratio LDL/HDL cholesterol .
The HYDRAGEL LDL/HDL CHOL Direct kit is designed for use with a manual electrophoresis apparatus. The kit is intended to run up to 8 samples per gel.
The HYDRAGEL 7 LDL/HDL CHOL Direct and HYDRAGEL LDL/HDL CHOL Direct 15/30 kits are designed for use with the semi-automated Hydrasys electrophoresis apparatus. These kits are intended to run up to 7, 15 and 30 samples per gel, respectively.
Product codes
LBT, LBS, JHO
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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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/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the head, body, and tail feathers. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services.
JUN 18 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Borek Janik Official Correspondent Morax 13805 Waterloo Road Chelsea, Michigan 48118
Re: K990250
Trade Name: Hydragel LDL/HDL Chol Direct Hydragel 7 LDL/HDL Chol Direct Hydragel LDL/HDL Chol Direct 15/30 Regulatory Class: I Reserved, Class I, Class I Product Code: LBT, LBS, JHO Dated: April 13, 1999 Received: April 19, 1999
Dear Dr. Janik:
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.
1
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/cdrl/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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
990250
510(k) Number (if known): 12
| Device name: | HYDRAGEL LDL/HDL CHOL DIRECT | PN 4005 |
|---|---|---|
| HYDRAGEL 7 LDL/HDL CHOL DIRECT | PN 4103 | |
| HYDRAGEL LDL/HDL CHOL DIRECT 15/30 | PN 4123 |
Indications For Use:
HYDRAGEL LDL/HDL CHOL DIRECT, HYDRAGEL 7 LDL/HDL CHOL DIRECT and HYDRAGEL LDL/HDL CHOL DIRECT 15/30 kits are designed for quantification of the cholesterol carried by the LDL and HDL lipoprotein fractions of human plasma or serum. The analysis is performed in two stages:
· electrophoresis on agarose gel to separate the VLDL, LDL and HDL as well as chylomicrons and Lp (a) when present,
· visualization of lipoprotein fractions based on a sensitive and cholesterol-specific enzymatic method involving cholesterol esterase and cholesterol oxidase, and a chromogenic system with reduced AEC (amino ethyl carbazole) and peroxidase.
The stained electrophoregrams are intended for visual interpretation to confirm identification of the individual fractions and for densitometry to obtain accurate, relative concentrations of cholesterol in the individual lipoprotein fractions If the sample's total cholesterol value is known, cholesterol distribution in g/dL or mol/L concentrations can be calculated. Since the LDL cholesterol and HDL cholesterol assays are of primary interest, laboratories may chose to measure the relative concentration of cholesterol only in the HDL and LDL fractions.
The procedure is indicated for the general population for a direct measurement of:
- the LDL cholesterol level regardless the triglyceride levels ◆
- . the HDL cholesterol level
- the ratio LDL/HDL cholesterol .
The HYDRAGEL LDL/HDL CHOL Direct kit is designed for use with a manual electrophoresis apparatus. The kit is intended to run up to 8 samples per gel.
The HYDRAGEL 7 LDL/HDL CHOL Direct and HYDRAGEL LDL/HDL CHOL Direct 15/30 kits are designed for use with the semi-automated Hydrasys electrophoresis apparatus. These kits are intended to run up to 7, 15 and 30 samples per gel, respectively.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Services | |
| 510(k) Number | k 990250 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |