(51 days)
Not Found
No
The summary describes a standard in vitro diagnostic test using prepackaged reagents and a clinical chemistry system. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance study is a simple comparison of a revised reagent cartridge to a previous version.
No
The device is described as an "in vitro diagnostic test" intended to "quantitatively measure high density lipoprotein cholesterol (HDL-C) in human serum and plasma," and these measurements are "used as an aid in the diagnosis of lipid disorders." It does not provide treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that "HDL-C measurements are used as an aid in the diagnosis of lipid disorders," and the "Device Description" section identifies it as an "in vitro diagnostic device."
No
The device description explicitly states it is a "reagent cartridge" which is a physical component used on a clinical chemistry system, indicating it is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states it is an "in vitro diagnostic test" intended to measure HDL-C in human serum and plasma.
- Device Description: Explicitly states it is an "in vitro diagnostic device".
N/A
Intended Use / Indications for Use
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.
Product codes
JHM
Device Description
The Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48A) is an in vitro diagnostic device that consists of prepackaged reagents in a plastic cartridge (Flex®) for use on the Dade Behring Dimension® clinical chemistry system.
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
Prescription Use
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
Split sample comparison between the "current" Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48) and the "revised" Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48A) was tested with clinical patient samples.
Summary of Performance Studies
Split sample comparison between the "current" Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48) and the "revised" Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48A) gave the following correlation statistics, when tested with clinical patient samples.
n = 101
Key Metrics
Slope: 1.04
Intercept: -3.38 [-0.09] mg/dL [mmol/L]
Correlation Coefficient: 0.995
Predicate Device(s)
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
OCT 3 0 2003
"revised" Dimension® Automated HDLCholesterol (AHDL) Flex® reagent cartridge (DF48A)
510(k) Summary
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.
| The assigned 510(k) number is : | 67 7 799
. 18 | |
|---------------------------------|------------------|--|
| | | |
Submitter's Name
Andrea M. Tasker Dade Behring Inc. Building 500, Mailbox 514 P.O.Box 6101 Newark, DE 19714-6101
Submission Preparation Date:
September 8, 2003
Device Name and Classification
| Trade Name: | Dimension® Automated HDL Cholesterol(AHDL) |
|---|---|
| Flex® reagent cartridge | |
| Common/Usual Name: | Colorimetric Method, Lipoprotein |
| Classification: | Class I |
| Product Code: | JHM |
Predicate Device
Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48) FDA Document Control No. K983849
Device Description
The Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48A) is an in vitro diagnostic device that consists of prepackaged reagents in a plastic cartridge (Flex®) for use on the Dade Behring Dimension® clinical chemistry system.
Intended Use
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.
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Comparison to Predicate Device
| | "Current" Dimension®
Automated HDL Cholesterol
Flex® reagent cartridge (DF48) | "Revised" Dimension®
Automated HDL Cholesterol
Flex® reagent cartridge (DF48A) |
|----------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Intended Use | For the measurement of high
density lipoprotein cholesterol | For the measurement of high
density lipoprotein cholesterol |
| Sample Type | Human Serum or Plasma | Human Serum or Plasma |
| Sample Volume | 3uL | 3uL |
| Detection | Enzymatic Colormetric
Bichromatic Endpoint | Enzymatic Colormetric
Bichromatic Endpoint |
| Wavelengths | 600 and 700 nm | 600 and 700nm |
| Reagent 1 Vol. | 300uL | 300uL |
| Reagent 2 Vol. | 100uL | 100uL |
| Methodology | Polyanion Selective
Detergent Methodology | Accelerator Selective
Detergent Methodology |
Comments on Substantial Equivalence
Split sample comparison between the "current" Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48) and the "revised" Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48A) gave the following correlation statistics, when tested with clinical patient samples.
| Revised AHDL (DF48A) | Intercept | Correlation | ||
|---|---|---|---|---|
| VS. | Slope | mg/dL [mmol/L] | Coefficient | n |
| Current AHDL (DF48) | 1.04 | -3.38 [-0.09] | 0.995 | 101 |
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Conclusion
The results of performance studies demonstrate that the "revised" Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48A) is substantially equivalent to the Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48) FDA Document Control No. K983849 .
Rua m. Ture
Andrea M. Tasker Senior Regulatory Affairs and Compliance Specialist Date: September 8, 2003
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference. Inside the circle is a stylized symbol of three human profiles facing right, with flowing lines representing hair or movement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Andrea M. Tasker Senior Regulatory Affairs and Compliance Specialist Dade Behring, Inc. Chemistry/Immunochemistry Glasgow Business Community Bldg. 500 - P.O. Box 6101 Newark, DE 19714
OCT 3 0 2003
Re: K032798
Trade/Device Name: Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48A) Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: JHM Dated: September 8, 2003 Received: September 9, 2003
Dear Ms. Tasker:
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).
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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 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 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 (301) 594-3084. 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 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 Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications For Use Statement
Device Name:
Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48A)
Indications for Use:
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.
Qun n. Tan
Andrea M. Tasker Senior Regulatory Affairs and Compliance Specialist
September 8, 2003
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) | |
| OR | |
| Over-the-counter Use | |
| (Optional format 1-2-96) | |
| Carol C Benson for Jean Cooper, DVM | |
| Division Sign-Off |
Office of In Vitro Diagnostic Device Evaluation and Safety
210(k)
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