(22 days)
No
The description focuses on the immunoassay technique and the instrument's automated processes, with no mention of AI or ML.
No
This device is an in vitro diagnostic test used for the quantitative measurement of cyclosporine A, which aids in the management of transplant patients. It does not directly provide therapy.
Yes
The device is described as an "in vitro diagnostic test" and its measurements are used as "an aid in the management of heart, liver and kidney transplant patients," clearly indicating its diagnostic purpose.
No
The device is an in vitro diagnostic test kit (reagent cartridge) used on a physical instrument system (Dimension Vista® system). It involves chemical reactions and physical separation steps, clearly indicating it is not software-only.
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 CSAE method is an in vitro diagnostic test. It is used for the quantitative measurement of cyclosporine A in human whole blood, which is a sample taken from the body.
- Device Description: The "Device Description" section refers to the Dimension Vista® CSAE Flex® reagent cartridge as a pre-packaged in-vitro diagnostic test method (assay). It also mentions that the device has been cleared under the 510(k) process for use on Dimension® clinical chemistry systems, which are instruments used for in vitro diagnostic testing.
- Predicate Device: The "Predicate Device(s)" section lists K052017, the Dimension® CSAE Flex® reagent cartridge, which is also described as an in-vitro diagnostic device in the "Device Description".
All of these points clearly indicate that the device is intended to be used outside of the body to examine specimens (in this case, whole blood) for diagnostic purposes.
N/A
Intended Use / Indications for Use
The CSAE method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista® system. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.
Product codes (comma separated list FDA assigned to the subject device)
MKW
Device Description
The Dimension Vista® CSAE 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 the Dimension® Cyclosporine Extended Range (CSAE) Flex® reagent cartridge (K052017), an in-vitro diagnostic device that has been cleared under the 510(k) process for use on Dimension® clinical chemistry systems. The packaging change is to allow use on the Dimension Vista® system. The modifications also include a change in method parameters (sample size and reagent volume) but the final concentration of sample/reagent ratio in test milieu remains the same.
The reagents contained in the Dimension Vista® CSAE Flex® reagent cartridges are the same as those contained in the Dimension® CSAE Flex® reagent cartridges manyfactured for the Dimension® clinical chemistry systems, another family of Siemens analyzers. The packaging modification does not affect the intended use of the devices, nor does it alter the fundamental scientific technology of the device.
The CSAE method uses an immunoassay technique in which free and CSA bound antibody-enzyme species are separated using magnetic particles. The CSAE Flex® reagent cartridge contains a pretreatment reagent, B-galactosidase-CSA antibody conjugate, CSA immobilized on chromium dioxide particles, chlorophenol red B-dgalactopyranoside (CPRG) substrate, and diluent to hydrate the tablets. To perform the CSAE assay, a sample cup containing the whole blood sample to be analyzed and a CSAE Flex® reagent cartridge are placed appropriately on the Dimension Vista® system. The Dimension Vista® system mixes and lyses the whole blood sample. The lysed sample is then mixed with the antibody conjugate reagent. The CSA present in the sample is bound by the CSA antibody conjugate reagent. Magnetic particles coated with cyclosporine A are added to bind free (unbound) antibody-enzyme conjugate. The reaction mixture is then separated magnetically. Following separation, the supernatant containing the CSA antibody-enzyme complex is transferred to a cuvette and mixed with the substrate. B-galactosidase catalyzes the hydrolysis of CPRG (chlorophenol red B-dgalactopyranoside) to produce CPR (chlorophenol red) that absorbs light maximally at 577mm. The change in absorbance at 577nm due to the formation of CPR is directly proportional to the amount of CSA in the patient's sample and is measured using a bichromatic (577, 700nm) rate technique.
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)
A split sample method comparison study was conducted on the Dimension Vista® CSAE Flex vs, the Dimension® CSAE Flex using one hundred and sixteen (116) transplant samples. The data was analyzed using least squares linear regression and produced the following regression statistics:
Slope: 0.92
Intercept: 37.9 ng/mL
r: 0.990
n: 116
The proposed Dimension Vista® CSAE method is substantially equivalent to the legally marketed device, the Dimension® CSAE method in design, principle, and performance. They have the same intended use and indications for use. Comparative testing also 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
§ 862.1235 Cyclosporine test system.
(a)
Identification. A cyclosporine test system is a device intended to quantitatively determine cyclosporine concentrations as an aid in the management of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and chromatographic assays for cyclosporine.(b)
Classification. Class II (special controls). The special control is “Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA.” See § 862.1(d) for the availability of this guidance document.
0
Dimension Vista® CSAE Flex® reagent cartridge Special 510(k) Premarket Notification
510(k) Summary of Safety and Effectiveness Dimension Vista® CSAE Flex® reagent cartridge
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
AUG - 5 2008
The assigned 510(k) number is: KO81992
1. Submitter's Contact Information and Date of Preparation
Siemens Healthcare Diagnostics Inc. Submitter's Contact Information: P.O. Box 6101 Newark, DE 19714-6601 Attn: Yuk-Ting Lewis Tel: 302-631-7626
Date of Preparation:
July 7, 2008
- Proprietary Device Name / FDA Classification Name 2. Dimension Vista® CSAE Flex® reagent cartridge / Cyclosporine test system
Identification of the Predicate Device 3. Dimension® CSAE Flex® reagent cartridge, K052017
4. Device Description
The Dimension Vista® CSAE 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 the Dimension® Cyclosporine Extended Range (CSAE) Flex® reagent cartridge (K052017), an in-vitro diagnostic device that has been cleared under the 510(k) process for use on Dimension® clinical chemistry systems. The packaging change is to allow use on the Dimension Vista® system. The modifications also include a change in method parameters (sample size and reagent volume) but the final concentration of sample/reagent ratio in test milieu remains the same.
The reagents contained in the Dimension Vista® CSAE Flex® reagent cartridges are the same as those contained in the Dimension® CSAE Flex® reagent cartridges manyfactured for the Dimension® clinical chemistry systems, another family of Siemens analyzers. The packaging modification does not affect the intended use of the devices, nor does it alter the fundamental scientific technology of the device.
1
The CSAE method uses an immunoassay technique in which free and CSA bound antibody-enzyme species are separated using magnetic particles. The CSAE Flex® reagent cartridge contains a pretreatment reagent, B-galactosidase-CSA antibody conjugate, CSA immobilized on chromium dioxide particles, chlorophenol red B-dgalactopyranoside (CPRG) substrate, and diluent to hydrate the tablets. To perform the CSAE assay, a sample cup containing the whole blood sample to be analyzed and a CSAE Flex® reagent cartridge are placed appropriately on the Dimension Vista® system. The Dimension Vista® system mixes and lyses the whole blood sample. The lysed sample is then mixed with the antibody conjugate reagent. The CSA present in the sample is bound by the CSA antibody conjugate reagent. Magnetic particles coated with cyclosporine A are added to bind free (unbound) antibody-enzyme conjugate. The reaction mixture is then separated magnetically. Following separation, the supernatant containing the CSA antibody-enzyme complex is transferred to a cuvette and mixed with the substrate. B-galactosidase catalyzes the hydrolysis of CPRG (chlorophenol red B-dgalactopyranoside) to produce CPR (chlorophenol red) that absorbs light maximally at 577mm. The change in absorbance at 577nm due to the formation of CPR is directly proportional to the amount of CSA in the patient's sample and is measured using a bichromatic (577, 700nm) rate technique.
5. Device Intended Use
The CSAE method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista® system. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.
Summary of the devices technological characteristics 6.
The Dimension Vista® CSAE Flex is substantially equivalent to other cyclosporine test systems, such as the Dimension® CSAE Flex® reagent cartridge (K052017). A comparison of features is provided.
| Feature | Modified Device:
Dimension Vista® CSAE
Flex® reagent cartridge | Predicate Device:
Dimension® CSAE Flex®
reagent cartridge |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reagents | Prepackaged, 12 well plastic Flex®
reagent cartridges | Prepackaged, 8 well plastic Flex®
reagent cartridges |
| Intended Use | The CSAE method is an in vitro
diagnostic test for the quantitative
measurement of cyclosporine A
(CSA) in human whole blood on
the Dimension Vista® system.
Measurements of CSA are used as
an aid in the management of heart,
liver and kidney transplant patients. | The CSAE method is an in vitro
diagnostic test for the quantitative
measurement of cyclosporine A
(CSA) in human whole blood on
the Dimension® clinical
chemistry system. Measurements
of CSA are used as an aid in the
management of heart, liver and
kidney transplant patients. |
2
Dimension Vista® CSAE Flex® reagent cartridge Special 510(k) Premarket Notification
| Feature | Modified Device:
Dimension Vista® CSAE
Flex® reagent cartridge | Predicate Device:
Dimension® CSAE Flex®
reagent cartridge |
|------------------------------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------|
| Final concentration
of sample/reagent
ratio in test milieu | Same concentration as the
predicate device | As described in K052017 |
| Reagent form | Same liquids and tablets | Liquids and tablets |
| # of chrome tablets | 2 | 3 |
| Total # of tests in
cach Flex®
cartridge | 30 | 20 |
| Calibration | 30 days | 30 days |
| Sample Type | Whole blood | Whole blood |
| Analytical
Measurement
Range | 350 – 2000 ng/mL | 350 - 2000 ng/mL |
| Sample Size | 1.12 µL | 3 µL |
| Measurement | Bichromatic endpoint
@ 577 and 700 nm | Bichromatic endpoint
@ 577 and 700 nm |
7. Method comparison to the predicate
A split sample method comparison study was conducted on the Dimension Vista® CSAE Flex vs, the Dimension® CSAE Flex using one hundred and sixteen (116) transplant samples. The data was analyzed using least squares linear regression and produced the following regression statistics:
| Slope | 0.92 |
|---|---|
| Intercept | 37.9 ng/mL |
| r | 0.990 |
| n | 116 |
8. Conclusion
The proposed Dimension Vista® CSAE method is substantially equivalent to the legally marketed device, the Dimension® CSAE method in design, principle, and performance. They have the same intended use and indications for use. Comparative testing also demonstrates substantially equivalent performance.
3
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services, USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the top half of the circle. In the center of the seal is a stylized image of an eagle.
SEP 2-2008
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Siemens Healthcare Diagnostics Inc. c/o Ms. Yuk-Ting Lewis Regulatory Affairs and Compliance Manager P.O. Box 6101, Mailbox 514 Newark, DE 19714-6101
Re: K081992
Trade/Device Name: Dimension Vista CSAE Flex Regent Cartridge, Model k4108 Regulation Number: 21 CFR 862.1235 Regulation Name: Cyclosporine Test System. Regulatory Class: Class II Product Code: MKW Dated: July 11, 2008 Received: July 14, 2008
Dear Ms. Lewis:
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. Ilsting 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 (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.
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
Indication for Use
510(k) Number (if known):
Device Name: Dimension Vista® CSAE Flex® reagent cartridge
2081992
Indications For Use:
The CSAE method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista® system. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.
Prescription Use ______x (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081992