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.

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.

AI/ML Overview

The provided text describes a 510(k) Special submission for a packaging modification of a device, the Dimension Vista™ Cyclosporine (CSA) Flex® reagent cartridge. This submission is primarily about demonstrating that the modified device (for use on the Dimension Vista™ system) is substantially equivalent to an existing predicate device (the Dimension® Cyclosporine (CSA) Flex® reagent cartridge, K023065).

The information provided focuses on the comparison between the new device and the predicate device, rather than a detailed study proving the new device's performance against specific acceptance criteria. The core of the submission is that the reagents and fundamental scientific technology are the same, and the packaging change does not affect its intended use.

Therefore, the study supporting this submission is not a typical clinical trial with detailed performance metrics against a defined ground truth, but rather a comparative study demonstrating substantial equivalence based on the device's characteristics and functionality.

Here's an analysis based on the provided text, addressing your questions where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria in this context are not explicitly stated as numerical performance targets (e.g., specific sensitivity/specificity values). Instead, the acceptance is based on demonstrating substantial equivalence to the predicate device. This means showing that the new device performs comparably to the predicate device and that any differences do not raise new questions of safety or effectiveness.

Feature	Acceptance Criteria (Implied)	Reported Device Performance (vs. Predicate)
Reagents	Same as predicate device	"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."
Intended Use	Same as predicate device	"in vitro diagnostic 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."
Indications for Use	Same as predicate device	"Same as Dimension® analyzer" and "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."
Tablet Sizes	Same as predicate device	7/32"
Total tests/cartridge	Same as predicate device	20
Calibration	Same as predicate device	30 days
Sample Type	Same as predicate device	whole blood
Reportable Range	Same as predicate device	25 - 500 ng/mL
Sample Size	Acceptable and demonstrated not to negatively impact performance (despite difference)	1.9 µL (predicate is 5 µL - this is a key difference)
Measurement Method	Same as predicate device	Bichromatic rate @ 577 & 700 nm
Packaging modification	Does not affect intended use or alter fundamental scientific technology	"The packaging modification, does not affect the intended use of the device, nor does it alter the fundamental scientific technology of the device."

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the sample size used for any specific testing to demonstrate substantial equivalence, nor does it specify data provenance (country of origin, retrospective/prospective). Given that this is a Special 510(k) for a packaging modification with the same reagents, the focus would likely be on analytical performance aspects (e.g., precision, accuracy using control materials or spiked samples) rather than a large-scale clinical study with patient samples. The only stated change with a potential impact on sample requirements is the "Sample Size" of 1.9 µL for the new device vs. 5 µL for the predicate. This would require validation that the reduced sample volume does not compromise performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable for this type of submission. The ground truth for in vitro diagnostic devices like this is typically established by reference methods or validated control materials, not expert consensus in the way a diagnostic imaging device might use radiologists.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the validation focuses on analytical performance characteristics of the assay rather than a subjective interpretation needing expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in vitro diagnostic reagent cartridge; it does not involve human readers or AI in the context of interpretation of medical images or other clinical data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device itself is a standalone assay system once integrated onto the Dimension Vista™ analyzer. Performance is measured by the accuracy and precision of the quantitative cyclosporine measurement. The "study" mentioned here is the comparison to the predicate device to demonstrate substantial equivalence, which would involve assessing the quantitative output of the device.

7. The Type of Ground Truth Used

The ground truth for this type of in vitro diagnostic quantitative assay would typically be established using:

Reference materials/calibrators: Materials with a known, accurately assigned concentration of cyclosporine.
Split samples: Comparing results from the new device with results from the predicate device (or another validated method) on the same patient samples.
Spiked samples: Samples (e.g., whole blood matrix) to which a known amount of cyclosporine has been added, allowing for recovery studies.

The document does not specify the exact type of ground truth used, but these are standard practices for IVD validation.

8. The Sample Size for the Training Set

Not applicable. This device is a reagent cartridge for a quantitative assay; it does not employ machine learning or AI models that require a "training set" in the conventional sense. Its performance is based on the chemical reactions and optical measurement principles of the assay.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

Summary

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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 PiestrakDade Behring Inc.P.O. Box 6101Newark, 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:

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.

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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™ CSAFlex® reagent cartridge	Dimension® CSAFlex® reagent cartridgeK023065
Reagents	Prepackaged, 12-well plastic, DadeBehring Flex® reagent cartridges	Prepackaged, 8 well plastic, DadeBehring Flex® reagent cartridges
Intended Use	in vitro diagnostic use	in vitro diagnostic use
Indications for Use	Same as Dimension® analyzer	The CSA Flex® reagent cartridgeis an in vitro diagnostic testintended to quantitatively measurecyclosporine concentrations inhuman whole blood for theDimension® clinical chemistrysystem. Measurements of CSA areused as an aid in the managementof heart, liver, and kidneytransplant patients.
Tablet Sizes	7/32"	7/32"
Total tests containedin 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

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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

K062236

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)

Page 1 of 1

CACL

Division Sign Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K062236

Regulation Number and Section

§ 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.