(113 days)
Not Found
No
The description details a chemical assay for measuring HDL-C and does not mention any computational or algorithmic components indicative of AI/ML.
No
The device is described as an in vitro diagnostic test for measuring HDL-C, which is used as an aid in diagnosis and risk assessment, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The AHDL method is an in vitro diagnostic test for the quantitative measurement of high-density lipoprotein cholesterol (HDL-C)... Measurements of HDL-C are used as an aid in the diagnosis of lipid disorders...".
No
The device description clearly outlines a chemical assay using reagents and a clinical chemistry system (Dimension®) to measure HDL-C. This involves physical components and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the AHDL method is an "in vitro diagnostic test".
- Sample Type: The test is performed on "human serum and plasma", which are biological samples taken from the body but tested outside of it.
- Purpose: The test is used to "aid in the diagnosis of lipid disorders", "various liver and renal diseases", and "in the assessment of risk for atherosclerosis and cardiovascular disease". These are all diagnostic purposes.
- Device Description: The description details a chemical reaction that occurs with the sample in vitro (in a test tube or similar container) to produce a measurable result.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AHDL method is an in vitro diagnostic test for the quantitative measurement of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on the Dimension® clinical chemistry system. Measurements of HDL-C are used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.
Product codes (comma separated list FDA assigned to the subject device)
JHM
Device Description
The AHDL assay measures HDL cholesterol levels directly without the need for sample pretreatment or specialized centrification steps, using a two reagent format. In the first reaction, chylpmicrons, VLDL and LDL form water soluble complexes with dextran sulfate in the presence of magnesium sulfate. These complexes are resistant to the polyethylene glycol (PEG)-modified cholesteril esterse and cholesterol oxidase that react with HDL cholesterol. In the presence of oxygen, the HDL cholesterol is oxidized to 24-cholestenone and hydrogen peroxide. The generated hydrogen peroxide then reacts with 4-aminoantipyrine and sodium N-(2-hydroxy-3-sulfopropyl)-3,5-dimethoxyaniline (HSDA) in the presence of peroxidase to form a colored dye that is measured using a bichromatic (600/700 nm) endpoint technique. The color intensity of the dye is directly proportional to the serum HDL-C concentration.
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)
Method comparison testing with human serum samples following CLSI Approved Guideline for Method Comparison and Bias Estimation Using Patient Samples; EP9-A2 demonstrates good analytical and clinical agreement between the methods giving the following linear regression statistics:
Comparative Method: Dimension AHDL (DF48A)
Slope: 1.04
Intercept: -3.9 mg/dL
Correlation Coefficient: 1.00
n: 130
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
FEB 21 201
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:
073072
1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation
Manufacturer:
Contact Information:
Dade Behring Inc. P.O. Box 6101 Newark, DE 19714
Dade Behring Inc. P.O. Box 6101 Newark, DE 19714 Attn: Pamela A. Jurga Tel: 302-631-8891
Date of Preparation:
October 30, 2007
2. Device Name / Classification
- . Dimension® AHDL Flex® reagent cartridge/ Class I
3. Identification of the Predicate Device
- Dimension® AHDL Flex® reagent cartridge (K032798) .
FDA Guidance Document(s):
- "Guidance on Informed Consent for In Vitro Diagnostic Device Studies . Using Leftover Human Specimens that are Not Individually Identifiable -Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff "- 4/25/2006
4. Device Description(s):
The AHDL assay measures HDL cholesterol levels directly without the need for sample pretreatment or specialized centrification steps, using a two reagent format. In the first reaction, chylpmicrons, VLDL and LDL form water soluble complexes with dextran sulfate in the presence of magnesium sulfate. These complexes are resistant to the polyethylene glycol (PEG)-modified cholesteril esterse
1
Dade Behring Inc. Dimension® AHDL Method 510(k) Premarket Notification
and cholesterol oxidase that react with HDL cholesterol. In the presence of oxygen, the HDL cholesterol is oxidized to 24-cholestenone and hydrogen peroxide. The generated hydrogen peroxide then reacts with 4-aminoantipyrine and sodium N-(2-hydroxy-3-sulfopropyl)-3,5-dimethoxyaniline (HSDA) in the presence of peroxidase to form a colored dye that is measured using a bichromatic (600/700 nm) endpoint technique. The color intensity of the dye is directly proportional to the serum HDL-C concentration.
5. Device Intended Use:
The AHDL method is an in vitro diagnostic test for the quantitative measurement of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on the Dimension® clinical chemistry system. Measurements of HDL-C are used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.
6. Medical device to which equivalence is claimed:
Substantial Equivalence:
This product is substantially equivalent to other HDL test systems, such as the Dimension® AHDL Flex® reagent cartridge (K032798).
Comparison to Predicate Device:
The proposed Dade Behring Dimension AHDL method and the predicate Dimension® AHDL method are both in vitro diagnostic assays intended for the quantitative measurement of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on the Dimension® clinical chemistry system.
A comparison summary of the features of the products is included in the following table.
Method:
| Item | Device | Predicate |
|---|---|---|
| Intended Use | The AHDL method is an in vitro diagnostic test for the quantitative measurement of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on the Dimension® clinical chemistry system. Measurements of HDL-C are used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease. | The AHDL method for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure high-density lipoprotein cholesterol (HDL-C) in human serum and plasma. HDL-C measurements are used as an aid in the diagnosis of lipid disorders |
2
| Sample Type | Human Serum or Plasma | Human Serum or Plasma |
|---|---|---|
| Sample Size | 3 uL | 3 uL |
| Measurement | ||
| method | PEG HDL-C (polyethylene | |
| modified) | Accelerator Selective Detergent | |
| Methodology | ||
| Measuring Range | 3-150 mg/dL | 3-150 mg/dL |
Comments on Substantial Equivalence:
The proposed Dade Behring Dimension AHDL method (DF48B) and the predicate Dimension® AHDL method (DF48A) are both in vitro diagnostic assays intended for the quantitative measurement of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on the Dimension® clinical chemistry system.
Method comparison testing with human serum samples following CLSI Approved Guideline for Method Comparison and Bias Estimation Using Patient Samples; EP9-A2 demonstrates good analytical and clinical agreement between the methods giving the following linear regression statistics:
| Comparative Method | Slope | Intercept
mg/dL | Correlation
Coefficient | n |
|------------------------|-------|--------------------|----------------------------|-----|
| Dimension AHDL (DF48A) | 1.04 | -3.9 | 1.00 | 130 |
Conclusion:
The proposed Dade Behring Dimension AHDL method (DF48B)and the predicate Dimension® AHDL method (DF48A) (K032798) are substantially equivalent based on their intended use and performance characteristics as described above.
Amella
Pamela A. Jurga Regulatory Affairs and Compliance Manager October 30, 2007
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and body.
Public Health Service
FEB 21 2008
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dade Behring, Inc. Glasgow Business Community c/o Ms. Pamela A. Jurga Regulatory Affairs and Compliance Manager P.O. Box 6101, Bldg. 500, M/S 514 Newark, DE 19714-6101
Re: K073072
Trade/Device Name: Dimension® AHDL Flex® Reagent Cartridge Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system. Regulatory Class: Class I, meets the limitation to exemption in 862.9(c)(4) Product Code: JHM Dated: January 25, 2008 Received: January 28, 2008
Dear Ms. Jurga:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
4
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 10gally marketed predicate device results in a classification for your device and thus, perceits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from to r Division of Small Manufacturers, International and Consumer Assistance at its toll free mumber (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device · Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Dade Behring Inc. Dimension® AHDL Method 510(k) Premarket Notification
Indications for Use
510(k) Number (if known): k 0 7 3072
Indications For Use:
The AHDL method is an in vitro diagnostic test for the quantitative measurement of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on the Dimension® clinical chemistry system. Measurements of HDL-C are used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.
Prescription Use ﮨﮯ (Per 21 CFR 801 Subpart D) AND/OR
Over-the-counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of -In Vitro Diagnostic Devices (OIVD)
Page 1 of 1
Dean Cooper, D.V.M.
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safet
073072