(81 days)
Not Found
No
The description details a standard immunochemical assay and calibration/control materials, with no mention of AI/ML in the device description, intended use, or performance studies.
No.
The device is described as an "in vitro diagnostic product" and "reagent cartridge" used for quantitative determination and calibration, which aids in diagnosis but does not provide direct therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the APOAI and APOB methods are "in vitro diagnostic tests" and that measurements aid "in the diagnosis and treatment of lipid disorders, various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease."
No
The device description clearly outlines physical components (reagent cartridges, calibrator, control) and a physical system (Dimension Vista® System) used for in vitro diagnostic testing. This is not a software-only device.
Yes, based on the provided text, these devices are In Vitro Diagnostics (IVDs).
Here's why:
- Explicitly Stated in Intended Use: The "Intended Use / Indications for Use" section for each product (APOAI Flex® reagent cartridge, APOB Flex® reagent cartridge, Apolipoprotein Calibrator, and Apolipoprotein Control) clearly states that they are "an in vitro diagnostic test" or "an in vitro diagnostic product".
- Purpose of the Devices: The descriptions indicate that these devices are used to analyze human biological samples (serum, heparinized plasma, or EDTA plasma) to measure specific substances (apolipoprotein A-1 and apolipoprotein B). This analysis is performed outside of the living body ("in vitro").
- Clinical Application: The measurements obtained from these tests are intended to "aid in the diagnosis and treatment of lipid disorders, various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease." This directly relates to providing information for medical diagnosis and treatment, which is a key characteristic of IVDs.
- Device Description: The description of the reagent cartridges details an immunochemical reaction with specific antibodies to measure proteins in human body fluids, further confirming the in vitro nature of the test.
- Calibrator and Control: The inclusion of a calibrator and control product, also labeled as "in vitro diagnostic product," is standard for IVD systems to ensure the accuracy and reliability of the test results.
Therefore, the text provides clear and consistent evidence that these devices are intended for use as In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Dimension Vista" APOAl Flex® reagent cartridge:
The APOAI method is an in vitro diagnostic test for the quantitative determination of apolipoprotein A-1 in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of apolipoprotein A-I aid in the diagnosis and treatment of lipid disorders, various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.
Dimension Vista™ APOB Flex® reagent cartridge:
The APOB method is an in vitro diagnostic test for the quantitative determination of apolipoprotein B in human serum, heparinized plasma or EDTA plasma on the Dimension Vista System. Measurements of apolipoprotein B aid in the diagnosis and treatment of lipid disorders, various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.
Dimension Vista™ Apolipoprotein Calibrator
Apolipoprotein Calibrator is an in vitro diagnostic product for the calibration of the Apolipoprotein A-I (APOAI) and Apolipoprotein B (APOB) methods on the Dimension Vista® System.
Dimension Vista™ Apolipoprotein Control
Apolipoprotein Control is an assayed intralaboratory quality control for assessment of precision and analytical bias in determination of apolipoprotein A-1 (APOAI) and apolipoprotein B (APOB) on the Dimension Vista® System.
Product codes (comma separated list FDA assigned to the subject device)
MSJ, JIX, JJY
Device Description
Dimension Vista™ APOAI and APOB Flex® reagent cartridges:
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista" Apolipoprotein Calibrator:
APO CAL is a multi-analyte, lyophilized, human serum based product containing apolipoprotein A-I and apolipoprotein B.
Dimension Vista™ Apolipoprotein Control:
APO CON is a multi-analyte, lyophilized, human serum based product containing apolipoprotein A-I and apolipoprotein B.
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)
The Dimension Vista™ APOAI and APOB assays were compared to the Dade The Dimension The Human Apo A-1 and Apo B assays on the BN ProSpec® System by evaluating serum samples with concentrations ranging from 0.61 g/L to 5.10 g/L for APOA1 and 0.38 g/L to 3.81 g/L for APOB. Regression analyses of these results yielded the following equations.
| Comparative Method | n | Slope | Intercept | Correlation Coefficient |
|---|---|---|---|---|
| N Antisera to Human Apo A-1 on the BN ProSpec® | 72 | 1.007 | -0.038 | 0.997 |
| N Antisera to Human Apo B on the BN ProSpec® | 77 | 1.011 | -0.004 | 0.995 |
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.
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510(k) Summary for Dimension Vista" APOAl Flex® reagent cartridge
Dimension Vista" APOB Flex® reagent cartridge Dimension Vista™ Apolipoprotein Calibrator
Dimension Vista™ Apolipoprotein Control
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.
KO63608 The assigned 510(k) number is:
- Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:
- Manufacturer: Dade Behring Marburg GmbH Emil-von-Behring Str. 76 35041 Marburg, Germany
- Contact Information: Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714-6101 Attn: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497
February 6, 2007 Preparation date:
- Dimension Vista™ APOAI Flex® reagent cartridge 2. Device Name: Dimension Vista™ APOB Flex® reagent cartridge Dimension Vista" Apolipoprotein Calibrator
Dimension Vista" Apolipoprotein Calibrator
Dimension Vista" Apolipoprotein Control
Classification: Class I; Class II; Class I (reserved) MSJ: JIX: JJY Product Code: Panel: Clinical Chemistry (75)
3. Identification of the Legally Marketed Device:
Dade Behring N Antisera to Human Apo A-1 - K860894 Dade Behring N Antisera to Human Apo B - K860894 Dade Behring Apolipoprotein Standard Serum - K041870 Dade Behring Apolipoprotein Control Serum CHD - K993310
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Device Description: 4.
Dimension Vista™ APOAI and APOB Flex® reagent cartridges:
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista" Apolipoprotein Calibrator:
APO CAL is a multi-analyte, lyophilized, human serum based product containing apolipoprotein A-I and apolipoprotein B.
Dimension Vista™ Apolipoprotein Control:
APO CON is a multi-analyte, lyophilized, human serum based product containing apolipoprotein A-I and apolipoprotein B.
5. Device Intended Use:
Dimension Vista" APOAl Flex® reagent cartridge:
The APOAI method is an in vitro diagnostic test for the quantitative determination of apolipoprotein A-1 in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of apolipoprotein A-I aid in the diagnosis and treatment of lipid disorders, various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.
Dimension Vista™ APOB Flex® reagent cartridge:
The APOB method is an in vitro diagnostic test for the quantitative determination of apolipoprotein B in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of apolipoprotien B aid in the diagnosis and treatment of lipid disorders, various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.
Dimension Vista" Apolipoprotein Calibrator:
The APO CAL is an in vitro diagnostic product for the calibration of the apolipoprotein A-I (APOAI) and apolipoprotein B (APOB) methods on the Dimension Vista® System.
Dimension Vista™ Apolipoprotein Control:
APO CON is an assayed intralaboratory quality control for assessment of precision and analytical bias in determination of apolipoprotein A-I (APOAI) and apolipoprotein B (APOB) on the Dimension Vista® System.
Medical device to which equivalence is claimed and comparison 6. information:
Dimension Vista™ APOAI and APOB, like Dade Behring N Antisera to Human Apolipoprotein A-1 and Apolipoprotein B are in vitro diagnostic tests for the quantitative measurement of apolipoprotein A-1 and apolipoprotein B in human serum.
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Device Performance Characteristics: 7.
The Dimension Vista™ APOAI and APOB assays were compared to the Dade The Dimension The Human Apo A-1 and Apo B assays on the BN ProSpec® System by evaluating serum samples with concentrations ranging from 0.61 g/L to 5.10 g/L for APOA1 and 0.38 g/L to 3.81 g/L for APOB. Regression analyses of these results yielded the following equations.
| Comparative Method | n | Slope | Intercept | Correlation
Coefficient |
|---------------------------------------------------|----|-------|-----------|----------------------------|
| N Antisera to Human Apo A-1
on the BN ProSpec® | 72 | 1.007 | -0.038 | 0.997 |
| N Antisera to Human Apo B
on the BN ProSpec® | 77 | 1.011 | -0.004 | 0.995 |
Method Comparison Study
8. Conclusion:
These studies demonstrate correlation and equivalent performance between the Dade Behring N Antisera to Human Apo A-1 and Apo B assays and the Dimension Vista" APOAI and APOB assays.
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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 image of an eagle with its wings spread, rendered in a stylized, minimalist design.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Kathleen Dray-Lyons Dade Behring, Inc. P.O. Box 6101 Newark, DE 19714-6101 US
FEB 2 3 2007
Re: K063608
Trade/Device Name: Dimension Vista™ APOA1 Flex® reagent cartridge Dimension Vista™ APOB Flex® reagent cartridges Dimension Vista™Apolipoprotein Calibrator Dimension Vista™Apolipoprotein Control Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system
Regulatory Class: Class II Product Code: MSJ, JIX, JJY Dated: December 01, 2006 Received: December 04, 2006
Dear Ms. Dray-Lyons:
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 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 (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 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.
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
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Indications Statement
Dimension Vista" APOAI Flex® reagent cartridge
Dimension Vista™ APOB Flex® reagent cartridge
Dimension Vista™ Apolipoprotein Calibrator Device Name: Dimension Vista™ Apolipoprotein Control
Indications for Use:
Dimension Vista" APOAI Flex® reagent cartridge:
The APOAI method is an in vitro diagnostic test for the quantitative determination of apolipoprotein A-I in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of apolipoprotein A-I aid in the diagnosis and treatment of lipid disorders, various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.
Dimension Vista™ APOB Flex® reagent cartridge:
The APOB method is an in vitro diagnostic test for the quantitative determination of apolipoprotein B in human serum, heparinized plasma or EDTA plasma on the Dimension Vista System. Measurements of apolipoprotein B aid in the diagnosis and treatment of lipid disorders, various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.
Dimension Vista™ Apolipoprotein Calibrator
Apolipoprotein Calibrator is an in vitro diagnostic product for the calibration of the Apolipoprotein A-I (APOAI) and Apolipoprotein B (APOB) methods on the Dimension Vista® System.
Dimension Vista™ Apolipoprotein Control
Apolipoprotein Control is an assayed intralaboratory quality control for assessment of precision and analytical bias in determination of apolipoprotein A-1 (APOAI) and apolipoprotein B (APOB) on the Dimension Vista® System.
Prescription Use × (Per 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 801)
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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
of the still Dingnostic Device
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