(19 days)
No
The summary describes a standard in vitro diagnostic test for measuring Cyclosporine A levels using a reagent cartridge on an automated system. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The submission is a Special 510(k) for a packaging modification, explicitly stating the fundamental scientific technology is unchanged.
No
This device is an in vitro diagnostic test used to measure cyclosporine levels in blood, aiding in the management of transplant patients, rather than directly providing therapy.
Yes
The device is explicitly stated as an "in vitro diagnostic test" and an "in vitro diagnostic device" in both the "Intended Use / Indications for Use" and "Device Description" sections, and its measurements are used as an aid in patient management.
No
The device is described as an in vitro diagnostic test method (assay) packaged in a reagent cartridge, which is a physical component containing chemical reagents. It is designed to be used on a physical instrument system (Dimension Vista™ System). This clearly indicates it is a hardware-based device with associated software for operation, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly Stated: The "Intended Use / Indications for Use" section clearly states: "The CSA method is an in vitro diagnostic test..." and "The Dimension Vista™ Cyclosporine (CSA) Flex® reagent cartridge is an in vitro device...".
- Definition of IVD: An in vitro diagnostic device is a medical device intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, in order to provide information for diagnostic, monitoring or compatibility purposes. This device fits this definition as it measures Cyclosporine A in human whole blood to aid in patient management.
- Device Description: The "Device Description" also refers to the reagent cartridges as "prepackaged in-vitro diagnostic test methods (assays)".
Therefore, based on the provided text, this device is definitively an IVD.
N/A
Intended Use / Indications for Use
The CSA 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 Dimension Vista™ Cyclosporine (CSA) Flex® reagent cartridge is an in vitro device intended to quantitatively determine cyclosporine concentrations in human whole blood. Measurements of CSA are used as an aid in the management of heart, liver, and kidney transplant patients receiving therapy with this drug.
Product codes
MKW
Device Description
Dade Behring Dimension Vista™ Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Dade Behring 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 (CSA) Flex® reagent cartridge (K023065), an in-vitro diagnostic device that has been cleared under the 510(k) process. The packaging change is to allow use on the Dimension Vista™ system.
The reagents contained in the Dimension Vista™ CSA Flex® reagent cartridges are the same as those contained in the CSA Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The packaging modification, does not affect the intended use of the device, nor does it alter the fundamental scientific technology of the device.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Dimension® Cyclosporine (CSA) Flex® reagent cartridge (K023065)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary of Safety and Effectiveness Informati
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.
| Submitter's Name: | Lorraine H Piestrak
Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101 |
|----------------------|------------------------------------------------------------------------------------|
| Date of Preparation: | August 1, 2006 |
| Name of Products: | Dimension Vista™ Cyclosporine (CSA) Flex® reagent cartridge |
AUG 2 1 2006### FDA Classification Name:
| Classification Name: | Common/Usual Name: |
|---|---|
| 862.1235 Cyclosporine | Cyclosporine test system |
Product code: MK W
Predicate Device:
Dimension® Cyclosporine (CSA) Flex® reagent cartridge (K023065)
Device Description:
Dade Behring Dimension Vista™ Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Dade Behring 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 (CSA) Flex® reagent cartridge (K023065), an in-vitro diagnostic device that has been cleared under the 510(k) process. The packaging change is to allow use on the Dimension Vista™ system.
The reagents contained in the Dimension Vista™ CSA Flex® reagent cartridges are the same as those contained in the CSA Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The packaging modification, does not affect the intended use of the device, nor does it alter the fundamental scientific technology of the device.
Intended Use:
The CSA method is an in vitro diagnostic test for the quantitative measurement of Cyclosporine A (CSA) in human whole blood on the Dimension Vista™ System.
1
Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.
Comparison to Predicate Device:
Both the Dimension Vista™ CSA Flex® reagent cartridges and the predicate Dimension® CSA Flex® reagent cartridges contain prepackaged reagents in flexible plastic cartridges. A comparison of the important similarities and differences between the two Flex® carridges is provided in the following table:
| Feature | Dimension Vista™ CSA
Flex® reagent cartridge | Dimension® CSA
Flex® reagent cartridge
K023065 |
|-----------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reagents | Prepackaged, 12-well plastic, Dade
Behring Flex® reagent cartridges | Prepackaged, 8 well plastic, Dade
Behring Flex® reagent cartridges |
| Intended Use | in vitro diagnostic use | in vitro diagnostic use |
| Indications for Use | Same as Dimension® analyzer | The CSA Flex® reagent cartridge
is an in vitro diagnostic test
intended to quantitatively measure
cyclosporine concentrations in
human whole blood for the
Dimension® clinical chemistry
system. Measurements of CSA are
used as an aid in the management
of heart, liver, and kidney
transplant patients. |
| Tablet Sizes | 7/32" | 7/32" |
| Total tests contained
in each Flex®
cartridge | 20 | 20 |
| Calibration | 30 days | 30 days |
| Sample Type | whole blood | whole blood |
| Reportable Range | 25 - 500 ng/mL | 25 - 500 ng/mL |
| Sample Size | 1.9 µL | 5 µL |
| Measurement | Bichromatic rate
@ 577 & 700 nm | Bichromatic rate
@ 577 & 700 nm |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" written around it.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Lorraine H Piestrak Regulatory Affairs and Compliance Manager Dade Behring Inc. P.O. Box 6101, M/S 514 Newark, DE 19714-6101
AUG 2 1 2006
K062236 Re:
Trade/Device Name: Dimension Vista™ Cyclosporine (CSA) Flex® reagent cartridge Regulation Number: 21 CFR 862.1235 Regulation Name: Cyclosporine test system Regulatory Class: Class II Product Code: MKW Dated: August 1, 2006 Received: August 2, 2006
Dear:
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) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto Garcia
Alberto Gutierrez, Ph.D. 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 for Use
510(k) Number (if known):
ﻣﺮ ﻣ
Dimension Vista™ Cyclosporine (CSA) Flex® reagent cartridge Device Name:
Indications For Use:
The Dimension Vista™ Cyclosporine (CSA) Flex® reagent cartridge is an in vitro device intended to quantitatively determine cyclosporine concentrations in human whole blood. Measurements of CSA are used as an aid in the management of heart, liver, and kidney transplant patients receiving therapy with this drug.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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CACL
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Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K062236