(55 days)
No
The description details a chemical assay and a microprocessor-controlled instrument system, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is an in vitro diagnostic test used for quantitative measurement of HDL-C in human serum and plasma to aid in the diagnosis of lipid disorders and assessment of risk for atherosclerosis and cardiovascular disease. It does not provide any therapeutic effect.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "an in vitro diagnostic test" and that its measurements are "used as an aid in the diagnosis of lipid disorders".
No
The device is described as an in vitro diagnostic test method (assay) involving reagents and a physical instrument system (Dimension Vista® system). It measures chemical reactions and color intensity, indicating it is a hardware-based device with associated software for control and analysis, not a standalone software device.
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 HDLC method is an "in vitro diagnostic test" for the quantitative measurement of HDL-C in human serum and plasma.
- Device Description: The "Device Description" refers to the Dimension Vista® HDCL Flex® reagent cartridge as a "pre-packaged in-vitro diagnostic test method (assay)".
- Nature of the Test: The description details a chemical reaction that occurs with a biological sample (serum and plasma) outside of the body to measure a specific analyte (HDL-C). This is the core characteristic of an in vitro diagnostic test.
The information provided clearly indicates that this device is designed to be used outside of the body to diagnose or aid in the diagnosis of medical conditions.
N/A
Intended Use / Indications for Use
The HDLC 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 Vista® 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
Dimension Vista® HDCL Flex® reagent cartridge is a pre-packaged in-vitro diagnostic test method (assay) that is specifically designed to be used on the Dimension Vista® Integrated system, a floor model, fully automated microprocessor-controlled, integrated instrument system. The Dimension Vista® system was previously cleared with seven associated test methods (K051087). This Special 510(k) is submitted for a packaging modification to in-vitro diagnostic (1001007). This bpeofal 270(t), 10 sthe 510(k) process for use on Dimension® clinical de vices mat nave occir evackaging change is to allow use on the Dimension Vista® system.
The reagents contained in the Dimension Vista® Flex® reagent cartridges are the same as those The Cagon's contained in the Dimendions manufactured for the Dimension® clinical chemistry contained in the I leagens analyzers. The packaging modification does not affect the systems, anomer lannity of themele sites the fundamental scientific technology of the device.
The HDLC assay measures serum HDL cholesterol levels directly without the need for sample I he IIDLC assury neasured seraillingation steps, using a two reagent format. In the first reaction, predeathene or spoculation communities with dextran sulfate in the presence of magnesium sulfate. These complexes are resistant to the polyethylene glycol (PEG)-modified cholesterol esterase (CE) and cholesterol oxidase (CO) that react with HDL cholesterol. In the second reaction, in the presence of oxygen, the HDL cholesterol is oxidized to A-4-cholestenone second readon, in the proomer of the generated hydrogen peroxide then reacts with 4-aminoantipyrine (4and IIyarogen percentive 3-sulfopropyl)-3,5-dimethoxyaniline (HSDA) in the presence of Art / and IN (2 hyrony 3 sairoped is measured using a bichromatic (600/700 nm) 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
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative testing demonstrates substantially equivalent performance.
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.
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
510(k) Summary of Safety and Effectiveness
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: K081300
Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation
| Manufacturer: | Siemens Healthcare Diagnostics Inc.
P.O. Box 6101
Newark, DE 19714-6101 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Siemens Healthcare Diagnostics Inc.
P.O. Box 6101
Newark, DE 19714-6601
Attn: Pamela A. Jurga
Tel: 302-631-8891 |
| Date of Preparation: | May 7, 2008 |
Device Name / Classification 2.
- Dimension Vista® HDLC Flex® reagent cartridge (K3408A) / Class I .
Identification of the Predicate Device 3.
- Dimension® AHDL Flex® reagent cartridge (K073072) t
FDA Guidance Document(s):
- "Replacement Reagent and Instrument Family Policy" 12/11/2003 .
- "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
Device Description(s): 4.
Dimension Vista® HDCL Flex® reagent cartridge is a pre-packaged in-vitro diagnostic test method (assay) that is specifically designed to be used on the Dimension Vista® Integrated system, a floor model, fully automated microprocessor-controlled, integrated instrument system. The Dimension Vista® system was previously cleared with seven associated test methods
1
(K051087). This Special 510(k) is submitted for a packaging modification to in-vitro diagnostic (1001007). This bpeofal 270(t), 10 sthe 510(k) process for use on Dimension® clinical de vices mat nave occir evackaging change is to allow use on the Dimension Vista® system.
The reagents contained in the Dimension Vista® Flex® reagent cartridges are the same as those The Cagon's contained in the Dimendions manufactured for the Dimension® clinical chemistry contained in the I leagens analyzers. The packaging modification does not affect the systems, anomer lannity of themele sites the fundamental scientific technology of the device.
The HDLC assay measures serum HDL cholesterol levels directly without the need for sample I he IIDLC assury neasured seraillingation steps, using a two reagent format. In the first reaction, predeathene or spoculation communities with dextran sulfate in the presence of magnesium sulfate. These complexes are resistant to the polyethylene glycol (PEG)-modified cholesterol esterase (CE) and cholesterol oxidase (CO) that react with HDL cholesterol. In the second reaction, in the presence of oxygen, the HDL cholesterol is oxidized to A-4-cholestenone second readon, in the proomer of the generated hydrogen peroxide then reacts with 4-aminoantipyrine (4and IIyarogen percentive 3-sulfopropyl)-3,5-dimethoxyaniline (HSDA) in the presence of Art / and IN (2 hyrony 3 sairoped is measured using a bichromatic (600/700 nm) technique. The color intensity of the dye is directly proportional to the serum HDL-C concentration.
Device Intended Use: ડ.
The HDLC 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 Vista " System. If your of 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.
Medical device to which equivalence is claimed: 6.
Substantial Equivalence:
This product is substantially equivalent to other HDL-C test systems, such as the Dimension® AHDL Flex® reagent cartridge (K073072).
Comparison to Predicate Device:
Both the Dimension Vista® HDLC Flex® reagent cartridges and the predicate Dimension® Doth the Dimension + 1.0 Lostain prepackaged reagents in flexible plastic cartridges. A AHDL I reass teagent cararteges contains and differences between the two Flex® cartridges is provided in the following table.
| Feature | Dimension Vista® HDLC
Flex® reagent cartridge
(K3408A) | Dimension® analyzer AHDL
Flex® reagent cartridge
(DF48B) K073072 |
|----------|--------------------------------------------------------------|------------------------------------------------------------------------|
| Reagents | Prepackaged, 12 well plastic Flex®
reagent cartridges | Prepackaged, 6 well plastic Flex®
reagent cartridges |
2
| Intended Use | The HDLC 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 Vista® 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 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. |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Final concentration
of sample/reagent
ratio in test milieu | Same as Dimension® analyzer | As described in K073072 |
| Reagent form | Liquid | Liquid |
| Total test
contained in each
Flex® cartridge | 120 tests | 30 tests |
| Calibration | 90 days | 90 days |
| Sample Type | Serum and lithium or sodium
heparin plasma | Serum and lithium or sodium
heparin plasma |
| Reportable Range | 3-150 mg/dL | 3-150 mg/dL |
| Sample Size | 1.3 µL | 3 µL |
| Measurement | Bichromatic endpoint
@ 600 and 700 nm | Bichromatic endpoint
@ 600 and 700 nm |
| Certification | Evaluated by and met the
certification criteria of the
Cholesterol Reference Method
Laboratory Network (CRMLN) | Evaluated by and met the
certification criteria of the
Cholesterol Reference Method
Laboratory Network (CRMLN) |
Conclusion:
The proposed Siemens Dimension Vista® HDLC method (K3048A) and the predicate Dimension® I the proposod Diomens Dikorian 2) are substantially equivalent in design, principle, and ATIDL mealou (121 40D) (1875011) the backers and indications for use. Comparative testing also demonstrates substantially equivalent performance.
Signature
Pamela A. Jurga Regulatory Affairs & Compliance Manager May 7, 2008
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL - 2 2008
Siemens Healthcare Diagnostics, Inc. c/o Pamela A. Jurga. Regulatory Affairs and Compliance Manager Glasgow Business Community P.O. Box 6101, Mail Stop 514 Newark, DE 19714-6101
Re: K081300
Trade/Device Name: Dimension Vista® HDLC Flex® reagent cartridge Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I, subject to 21 CFR sec. 862.9(c)(4) Product Code: JHM Dated: June 23, 2008 Received: June 24, 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).
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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 1egally 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 (240) 276-0490. Also, please not 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 (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.
Jean 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
Indications for Use
1681300 510(k) Number (if known):
Indications For Use:
The HDLC 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 Vista® 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 V (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
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081300