CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE

K023065 · Dade Behring, Inc. · MKW · Oct 16, 2002 · Clinical Chemistry

Device Facts

• Record ID: K023065
• Device Name: CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
• Applicant: Dade Behring, Inc.
• Product Code: MKW · Clinical Chemistry
• Decision Date: Oct 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1235
• Device Class: Class 2

Indications for Use

The CSA Flex® reagent cartridge is an in vitro diagnostic test intended to quantitatively measure cyclosporine A (CSA) 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.

Device Story

The CSA Flex® reagent cartridge is an in vitro diagnostic assay for use on the Dimension® clinical chemistry system. It processes human whole blood samples using an affinity particle-mediated immunoassay. The device separates free and CSA-bound antibody-enzyme species via magnetic particles; the resulting complex reacts with a substrate, where β-galactosidase catalyzes the hydrolysis of CPRG to produce chlorophenol red. The system measures the change in absorbance at 577 nm (bichromatic 577/700 nm) to quantify CSA concentration. Used in clinical laboratory settings by trained personnel, the output provides quantitative CSA levels to healthcare providers to assist in managing transplant patients. The device aids in therapeutic drug monitoring, helping clinicians adjust immunosuppressive therapy.

Clinical Evidence

Clinical performance was evaluated via a split-sample comparison against the Abbott TDx® CSA assay using 667 patient samples. Results showed a correlation coefficient of 0.957, a slope of 0.83, and an intercept of -20.7 ng/mL. The slope variance was attributed to differences in metabolite cross-reactivity between the two assays.

Technological Characteristics

Affinity particle-mediated immunoassay; mouse monoclonal antibody; bichromatic rate measurement (577 nm and 700 nm); magnetic particle separation; reagent cartridge format for use on the Dimension® clinical chemistry system.

Indications for Use

Indicated for the quantitative measurement of cyclosporine A (CSA) in human whole blood to aid in the management of heart, liver, and kidney transplant patients.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Abbott TDx® Cyclosporine Monoclonal Whole Blood Assay (P890025)

Submission Summary (Full Text)

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Uui 16 2002

DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714

ul 1 6 2002

DADE BEHRING
K023065

### Summary of Safety and Effectiveness Information

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 Piestrak<br>Dade Behring Inc.<br>P.O. Box 6101<br>Newark, DE 19714-6101 |
|--------------------------|----------------------------------------------------------------------------------|
| Date of Preparation: | April 10, 2001 |
| Name of Product: | Cyclosporine (CSA) Flex® reagent cartridge |
| FDA Classification Name: | Cyclosporine Test System |
| Predicate Device: | Abbott TDx® Cyclosporine Monoclonal Whole Blood Assay (P890025) |

Device Description: The automated Dimension® CSA method uses an immunoassay technique in which free and CSA-bound antibody-enzyme species are separated using magnetic particles. Following separation, the CSA-antibody-enzyme complex is mixed with the substrate. Bgalactosidase catalyzes the hydrolysis of CPRG (chlorophenol red ß-d- galactopyranoside) to produce CPR (chlorophenol red) that absorbs light maximally at 577 nm. The change in absorbance at 577 nm 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, 700 nm) rate technique.

Intended Use: The CSA Flex® reagent cartridge is an in vitro diagnostic test intended to quantitatively measure cyclosporine A (CSA) 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.

#### Comparison to Predicate Device:

| Item | CSA Flex® reagent cartridge | TDx® CSA |
|-------------------|----------------------------------------------|------------------------------------------|
| Sample Type | Whole blood | Whole blood |
| Technology | Affinity Particle<br>Mediated Immunoassay | Fluorescence Polarization<br>Immunoassay |
| Antibody | Mouse monoclonal | Mouse monoclonal |
| Detection | Bichromatic (577,700 nm)<br>rate measurement | Fluorometric endpoint<br>measurement |
| Assay sensitivity | 25.00 ng/mL | 25.00 ng/mL |

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## Comments on Substantial Equivalence:

Split sample comparison between the CSA Flex® reagent cartridge on the Dimension® clinical chemistry system and the Abbott TDx® CSA assay gave a correlation coefficient of 0.957, slope of 0.83, and an intercept of - 20.7 ng/mL [-18.6 nmol/L] when tested with 667 clinical patient samples. Comparative method slope results were expected due to metabolite cross-reactivity differences.

The Cyclosporine(CSA) Flex® reagent cartridge is substantially equivalent in Conclusion: principle and performance to the Abbott TDx® Cyclosporine Monoclonal Whole Blood assay.

Louanie Prestiak

Lorraine Piestrak Regulatory Affairs and Compliance Manager April 10, 2001

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Lorraine Piestrak Regulatory Affairs and Compliance Manager Dade Behring, Inc. Chemistry/Immunochemistry Glasglow Business Community P.O. Box 6101 - Building 500 Newark, DE 19714

OCT 1 6 2002

k023065 Re:

Trade/Device Name: Cyclosporine (CSA) Flex® reagent cartridge Regulation Number: 21 CFR 862.1235 Regulation Name: Cyclosporine test system Regulatory Class: Class II Product Code: MK W Dated: September 13, 2002 Received: September 16, 2002

Dear Ms. Piestrak:

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. Iisting 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications For Use Statement

K023065

Device Name: Cyclosporine (CSA) Flex® reagent cartridge

## Indications for Use:

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The CSA Flex® reagent cartridge is an in vitro diagnostic test intended to quantitatively measure cyclosporine A (CSA) 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.

Louane Pertiak

orraine Piestrak Regulatory Affairs and Compliance Manager

April 10, 2001 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the-counter Use

(Optional format 1-2-96)

Sean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K023065