(150 days)
Not Found
K20
No
The description focuses on electrophoresis and densitometry for visual interpretation and calculation, with no mention of AI or ML.
No
The device is described as a diagnostic tool used for quantifying cholesterol in lipoprotein fractions to aid in the diagnosis and treatment of lipid disorders, not for providing therapy itself.
Yes
The device aids in the diagnosis and treatment of lipid disorders by measuring LDL and HDL cholesterol levels.
No
The device description clearly outlines a kit involving electrophoresis on agarose gel, visualization of lipoprotein fractions using enzymatic procedures, and densitometry. These are physical components and processes, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the kits are "designed for quantification of the cholesterol carried by the Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) fractions of human serum." It also states that the results are "indicated as an aid in the diagnosis and treatment of lipid disorders."
- Sample Type: The analysis is performed on "human serum," which is a biological sample taken from the human body.
- Purpose: The purpose is to measure specific analytes (LDL and HDL cholesterol) in the sample to provide information for medical diagnosis and treatment.
- Procedure: The procedure involves laboratory techniques (electrophoresis and enzymatic reactions) performed outside of the living body ("in vitro").
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HYDRAGEL LDLIHDL CHOL Direct K20, HYDRAGEL 7 LDLIHDL CHOL Direct and HYDRAGEL LDLHDL CHOL Direct 15/30 kits are designed for quantification of the cholesterol canied by the Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) fractions of human serum. The analysis is performed in two stages:
· electrophoresis on agarose get to separate the VLDL, LDL and HDL as well as chylomicrons,
· visualization of lipoprotein fractions based on a sensitive and cholesterol-specific enzymatic procedure involving the cholesterol esterase / cholesterol dehydrogenase system coupled with nitro blue tetrazolium chromogen.
The stained electrophoregrams are intended for visual interpretation to confirm identification of the individual fractions and for densitometry to obtain relative concentrations of cholesterol in the individual lipoprotein fractions. When the sample's total cholesterol value is known, cholesterol distribution in a/dL or mol/L concentrations can be calculated.
The test system is intended for the measurement of the LDL cholesterol and HDL cholesterol. The cholesterol values of only these two fractions are indicated as an aid in the diagnosis and treatment of lipid disorders.
The procedure is indicated for the general population for a direct measurement of:
- . the LDL cholestero! level regardless the triglyceride levels
- the HDL cholesterol level .
- the ratio LDL/HDL cholesterol .
The HYDRAGEL LDUHDL CHOL Direct K20 kit is designed for use with a manual electrophoresis apparatus, K20. The kit is intended to run up to 7 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
JHO
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
Not Found
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 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 an abstract symbol resembling three stylized stripes or chevrons, which are meant to represent the human services aspect of the department.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 7 2002
Borek Janik, Ph.D. Official Correspondent Morax 13805 Waterloo Chelsea, MI 48118
K012789 Re:
Trade/Device Name: HYDRAGEL LDL/HDL CHOL Direct K20 PN 3005 HYDRAGEL 7 LDL/HDL CHOL Direct PN 4109 HYDRAGEL LDL/HDL CHOL Direct 15/30 PN 4129
Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: JHO Dated: December 21, 2001 Received: December 27, 2001
Dear Dr. Janik:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 -
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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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
510(k) Number (if known): Special 510(k): Device Modification
| Device name: | HYDRAGEL LDL/HDL CHOL Direct K20 | PN 3005 |
|---|---|---|
| HYDRAGEL 7 LDL/HDL CHOL Direct | PN 4109 | |
| HYDRAGEL LDL/HDL CHOL Direct 15/30 | PN 4129 |
Indications For Use:
HYDRAGEL LDLIHDL CHOL Direct K20, HYDRAGEL 7 LDLIHDL CHOL Direct and HYDRAGEL LDLHDL CHOL Direct 15/30 kits are designed for quantification of the cholesterol canied by the Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) fractions of human serum. The analysis is performed in two stages:
· electrophoresis on agarose get to separate the VLDL, LDL and HDL as well as chylomicrons,
· visualization of lipoprotein fractions based on a sensitive and cholesterol-specific enzymatic procedure involving the cholesterol esterase / cholesterol dehydrogenase system coupled with nitro blue tetrazolium chromogen.
The stained electrophoregrams are intended for visual interpretation to confirm identification of the individual fractions and for densitometry to obtain relative concentrations of cholesterol in the individual lipoprotein fractions. When the sample's total cholesterol value is known, cholesterol distribution in a/dL or mol/L concentrations can be calculated.
The test system is intended for the measurement of the LDL cholesterol and HDL cholesterol. The cholesterol values of only these two fractions are indicated as an aid in the diagnosis and treatment of lipid disorders.
The procedure is indicated for the general population for a direct measurement of:
- . the LDL cholestero! level regardless the triglyceride levels
- the HDL cholesterol level .
- the ratio LDL/HDL cholesterol .
The HYDRAGEL LDUHDL CHOL Direct K20 kit is designed for use with a manual electrophoresis apparatus, K20. The kit is intended to run up to 7 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 De | |
| 510(k) Number | K012789 |
| Prescription Use (Per 21 CFR 801,109) | OR | Over-The Counter Use ______ |
|---|---|---|
| --------------------------------------- | ---- | ----------------------------- |
(Optional Format 1-2-96)