(150 days)
Not Found
Not Found
No
The description details a manual or semi-automated electrophoresis process with visual interpretation and densitometry, with no mention of AI or ML.
No
The device is used for quantifying cholesterol carried by lipoproteins, which is an in vitro diagnostic procedure for analysis, not a therapeutic intervention.
Yes
Explanation: The device is designed for the "quantification of the cholesterol" carried by lipoproteins, and the results are primarily used "to confirm identification of the individual fractions" and obtain "relative concentrations of cholesterol". This information is used for diagnostic purposes, specifically in assessing lipid profiles.
No
The device description explicitly details physical components like agarose gels, electrophoresis apparatus, and chemical reagents for enzymatic reactions, indicating it is a hardware-based diagnostic kit.
Based on the provided text, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the kits are designed for the "quantification of the cholesterol carried by the HYDRAGEE 50 OFFE Friend or serum." This involves analyzing a biological sample (serum) outside of the body to obtain information about a health condition (cholesterol levels in different lipoprotein fractions).
- Device Description: The description details a process involving electrophoresis and enzymatic reactions performed on a biological sample (serum) to visualize and quantify components within that sample. This is a typical IVD process.
- Intended User / Care Setting: The intended user is listed as "Clinical Laboratory Devices," which is a common setting for IVD testing.
The core function of the device is to analyze a biological sample in vitro (outside the body) to provide diagnostic information about a patient's cholesterol levels. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HYDRAGEL CHOL-HDL, HYDRAGEL 7 CHOL-HDL, HYDRAGEL 15 CHOL-HDL and HYDRAGEL 30 CHOL-HDL kits are designed for quantification of the cholesterol carried by the HYDRAGEE 50 OFFE Friend or serum. This analysis is performed by electrophoresis on alkaline buffered (pH 9.4) agarose gels. The separated lipoproteins are visualized by a of alkaline banered (p).
cholesterol-specific enzymatic reaction. The stained electrophoregrams are to be interpreted visually to confirm identification of the individual fractions and by densitometry to obtain viccurale, relative concentrations of cholesterol in the individual lipoprotein fractions if the somole's total cholesterol value is known, cholesterol distribution in g/l or mol/l concentrations can be calculated. Since the HDL cholesterol assay is of primary interest, laboratories may chose to measure the relative concentration of cholesterol only in the HDL fraction.
Product codes
LBT
Device Description
All HYDRAGEL CHOL-HDL kits utilize the same composition of alkaline buffered HYDRAGEL CHOL-HDL agarose gels and the same procedure. It is carried out 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 HYDRAGEL CHOL-HDL 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 CHOL-HDL, HYDRAGEL 15 CHOL-HDL and HYDRAGEL 30 CHOL-HDL 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.
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.
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Image /page/0/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal features the department's logo, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the logo.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 27 1997
Dr. Borek Janik Official Correspondent Morax, Inc. 13805 Waterloo 48118 Chelsea, Michagan
K972015 Re : HYDRAGEL CHOL-HDL Kit and HYDRAGEL7, 15, & 30 CHOL-HDL Kits Requlatory Class: I Product Code: LBT Dated: September 17, 1997 Received: September 22, 1997
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 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 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 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 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 miqht have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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/cdrh/dsmamain.html".
Sincerely yours,
Steven Bitman
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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Image /page/2/Picture/0 description: The image contains a handwritten text string that appears to be a combination of letters and numbers. The string starts with the letters 'K' and 'q', followed by the number '7', and then the year '2015'. The handwriting style is casual and slightly stylized, with some characters connected and others distinct.
Page 1 of 1
510(k) Number (if known):
Device name:
HYDRAGEL CHOL-HDL KIT HYDRAGEL 7 CHOL-HDL KIT HYDRAGEL 15 CHOL-HDL KIT HYDRAGEL 30 CHOL-HDL KIT
Indications For Use:
HYDRAGEL CHOL-HDL, HYDRAGEL 7 CHOL-HDL, HYDRAGEL 15 CHOL-HDL and HYDRAGEL 30 CHOL-HDL kits are designed for quantification of the cholesterol carried by the HYDRAGEE 50 OFFE Friend or serum. This analysis is performed by electrophoresis on alkaline buffered (pH 9.4) agarose gels. The separated lipoproteins are visualized by a of alkaline banered (p).
cholesterol-specific enzymatic reaction. The stained electrophoregrams are to be interpreted visually to confirm identification of the individual fractions and by densitometry to obtain viccurale, relative concentrations of cholesterol in the individual lipoprotein fractions if the somole's total cholesterol value is known, cholesterol distribution in g/l or mol/l concentrations can be calculated. Since the HDL cholesterol assay is of primary interest, laboratories may chose to measure the relative concentration of cholesterol only in the HDL fraction.
All HYDRAGEL CHOL-HDL kits utilize the same composition of alkaline buffered HYDRAGEL CHOL-HDL agarose gels and the same procedure. It is carried out 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 HYDRAGEL CHOL-HDL 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 CHOL-HDL, HYDRAGEL 15 CHOL-HDL and HYDRAGEL 30 CHOL-HDL 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 Devices
510(k) Number K972015
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use
(Optional Format 1-2-96)_