(73 days)
Not Found
No
The description focuses on a chemical assay method and does not mention any AI or ML components.
No.
The device measures HDL cholesterol for diagnosis and treatment of lipid disorders; it does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" states that "AHDL measurements are used as an aid in the diagnosis and treatment of lipid disorders." This indicates its role in contributing to a diagnosis.
No
The device description clearly outlines a chemical assay method involving reagents and reactions, indicating a hardware-dependent laboratory test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used to "quantitatively measure High Density Lipoprotein Cholesterol in human serum or plasma." This involves testing biological samples in vitro (outside the body).
- Indications for Use: The indications for use state that the measurements are used "as an aid in the diagnosis and treatment of lipid disorders." This directly aligns with the purpose of IVDs, which are used to provide information for diagnostic or therapeutic purposes.
- Device Description: The description details a method for analyzing components of a biological sample (serum or plasma) using chemical reactions and reagents. This is characteristic of an IVD.
The information provided clearly indicates that this device is designed to perform tests on biological samples in vitro to provide information relevant to a patient's health status, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AHDL method for the Dimension® clinical chemistry system is a device used to quantitatively measure High Density Lipoprotein Cholesterol in human serum or plasma. AHDL measurements may be used in the diagnosis and treatment of lipid disorders.
Product codes
JHM
Device Description
The AHDL method for the Dimension® clinical chemistry system is a homogeneous method for direct measurement of high density lipoprotein (HDL) cholesterol levels without the need for off-line pretreatment or centrifugation steps.
The method is in a two-reagent format and depends on the properties of a unique detergent, which solubilizes only the HDL particles, thus releasing HDL cholesterol to react with cholesterol esterase to produce color. In addition to selectively disrupting the HDL particles, this detergent also inhibits the reaction of the cholesterol enzymes with LDL, VLDL and chylomicrons by adsorbing to their surfaces. A polyanion is contained in the first reagent to assist with complexing LDL, VLDL and chylomicrons, further enhancing the selectivity of the detergent and enzymes for HDL cholesterol.
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)
Split sample comparison between the Dimension® AHDL method and the Dimension® HDL assay gave a correlation coefficient of 0.991, slope of 0.931, and an intercept of 0.811 mg /dL when tested with 272 clinical patient samples ranging from 9 - 105 mg/dL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Dimension® High Density Lipoprotein Cholesterol (HDL) Assay
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
JAN 1 1 1999
DADE BEHRING
DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714
Submitter's Name:
Summary of Safety and Effectiveness Information
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Rebecca S. Ayash Dade Behring Inc. Building 500. Mailbox 514 P.O. Box 6101 Newark, DE 19714-6101
Date of Preparation: 10/29/98
Device Name: Dimension® Automated High Density Lipoprotein Cholesterol (AHDL) Flex™ reagent cartridge
Classification Name: Colorimetric Method, Lipoprotein
Predicate Device: Dimension® High Density Lipoprotein Cholesterol (HDL) Assay
Device Description: The AHDL method for the Dimension® clinical chemistry system is a homogeneous method for direct measurement of high density lipoprotein (HDL) cholesterol levels without the need for off-line pretreatment or centrifugation steps.
The method is in a two-reagent format and depends on the properties of a unique detergent, which solubilizes only the HDL particles, thus releasing HDL cholesterol to react with cholesterol esterase to produce color. In addition to selectively disrupting the HDL particles, this detergent also inhibits the reaction of the cholesterol enzymes with LDL, VLDL and chylomicrons by adsorbing to their surfaces. A polyanion is contained in the first reagent to assist with complexing LDL, VLDL and chylomicrons, further enhancing the selectivity of the detergent and enzymes for HDL cholesterol.
Image /page/0/Figure/13 description: This image shows a series of chemical reactions. LDL, VLDL, and Chylomicrons react with detergent and polyanion to form stable complexes. HDL reacts with detergent to become disrupted. HDL Cholesterol reacts with Cholesterol esterase and Cholesterol oxidase to form Δ' Cholestenone + H₂O₂, and H₂O₂ + DSBmT + 4AA reacts with Peroxidase to produce color development.
DSBmT = N.N-bis(4-sulphobuty)) m-toluidine-disodium
1
Intended Use: The AHDL method for the Dimension® clinical chemistry system is a device used to quantitatively measure High Density Lipoprotein Cholesterol in human serum or plasma. AHDL measurements may be used in the diagnosis and treatment of lipid disorders.
Comparison to Predicate Device:
| Item | Dimension® AHDL Method | Dimension® HDL Method |
|---|---|---|
| Technology | Direct homogeneous | Manual phosphotungsate |
| precipitation | ||
| Detection | Enzymatic colorimetric | |
| bichromatic endpoint | Enzymatic colorimetric | |
| polychromatic endpoint | ||
| Separation | Polyanions, detergent | Centrifugation |
| Sample Size | 3 µL | 250 µL |
| Sample Type | serum or plasma | serum or plasma |
| Intended Use | For the measurement of high | |
| density lipoprotein cholesterol | For the measurement of high | |
| density lipoprotein cholesterol |
Comments on Substantial Equivalence: Split sample comparison between the Dimension® AHDL method and the Dimension® HDL assay gave a correlation coefficient of 0.991, slope of 0.931, and an intercept of 0.811 mg /dL when tested with 272 clinical patient samples ranging from 9 - 105 mg/dL.
Conclusion: The AHDL Method for the Dimension® clinical chemistry system is substantially equivalent in principle and performance to the Dimension® HDL method based on the split sample comparison summarized above.
Rebecca S. Ayash
Rebecca S. Avas Regulatory Affairs and Compliance Manager Date: 10/29/98
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
Public Health Service
JAN 1 1 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Rebecca S. Ayash Regulatory Affairs and Compliance Manager Dade Behring, Inc. Glasgow Building 500 Mail Box 514 P.O. box 6101 Newark, DE 19714
Re: K983849
Trade Name: Dimension Automated High Density Lipoprotein Cholesterol Flex™ reagent cartridge
Regulatory Class: I Product Code: JHM Dated: October 29, 1998 Received: October 30, 1998
Dear Ms. Ayash:
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 OS 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.
3
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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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
4
Indications Statement
Device Name: Dimension® Automated High Density Lipoprotein Cholesterol (AHDL) Flex™ reagent cartridge
Indications for Use: The AHDL method for the Dimension® clinical chemistry system is a device used to quantitatively measure High Density Lipoprotein Cholesterol in human serum or plasma. AHDL measurements are used as an aid in the diagnosis and treatment of lipid disorders.
Rebecca S. Ayish
Rebecca S. Avash & Regulatory Affairs and Compliance Manager Date: 10/29/98
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K983849
510(k) Number
Patricio Benlert
Division Sign Off by M. Alfred Mortson
err Dr. Co. Division Sign-Off Office of Device Evaluation
prescription use
5