(30 days)
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.
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.
The provided text describes the summary of safety and effectiveness information for the Dade Behring Inc. Cyclosporine (CSA) Flex® reagent cartridge. It primarily focuses on demonstrating substantial equivalence to a predicate device. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a typical quantitative framework (e.g., "correlation coefficient must be > 0.90"). Instead, it presents a comparison to a predicate device and then reports the performance of the new device against that predicate, implying that the reported values met the implicit criteria for substantial equivalence.
| Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (CSA Flex® vs. Abbott TDx® CSA) |
|---|---|
| Good correlation coefficient | 0.957 |
| Acceptable slope | 0.83 (Note: "Comparative method slope results were expected due to metabolite cross-reactivity differences," implying this value was acceptable despite not being closer to 1) |
| Acceptable intercept | -20.7 ng/mL [-18.6 nmol/L] |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 667 clinical patient samples
- Data Provenance: The data is described as "clinical patient samples," suggesting it's from human subjects. The country of origin is not specified but is implicitly within the region where Dade Behring Inc. operates (Newark, DE, USA). The study appears to be retrospective in nature as it involved collecting and testing existing clinical samples to compare the two methods.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly mention the use of experts to establish ground truth for this specific comparison study. The comparison is between two quantitative diagnostic assays (the investigational device, CSA Flex®, and the predicate device, Abbott TDx® CSA). In such cases, the "ground truth" for the comparison is typically the result from the established predicate method or a reference method.
4. Adjudication Method for the Test Set
Not applicable. This was a direct comparison study between two quantitative methods, not a study requiring expert adjudication of qualitative interpretations.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers' Improvement with AI vs. Without AI Assistance
Not applicable. This is an in vitro diagnostic device for quantitative measurement of cyclosporine A, not an imaging or diagnostic interpretation device that involves human readers or AI assistance in interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the study described is a standalone performance comparison. The CSA Flex® reagent cartridge on the Dimension® clinical chemistry system is a device that provides quantitative measurements. The comparison was directly between the quantitative results of the CSA Flex® and the predicate TDx® CSA assay, without human intervention in the result generation or interpretation that would change the quantitative output.
7. The Type of Ground Truth Used
The ground truth used for this comparison study was the results obtained from the predicate device, the Abbott TDx® Cyclosporine Monoclonal Whole Blood Assay. The study essentially compared the new device's performance against an established and legally marketed device.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" for the CSA Flex® reagent cartridge. This type of FDA submission (510(k) for an in vitro diagnostic assay) typically focuses on performance validation rather than machine learning model training as understood in AI/ML contexts. The device's development would involve internal validation and optimization, but distinct "training set" reporting as might be found for AI models is not present here.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" is mentioned in the context of machine learning for this device, the method for establishing its ground truth is not detailed. For chemical assays, the development process generally involves optimizing reagents and protocols against known standards and reference materials, rather than a labeled training dataset of patient samples.
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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 PiestrakDade Behring Inc.P.O. Box 6101Newark, 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 ParticleMediated Immunoassay | Fluorescence PolarizationImmunoassay |
| Antibody | Mouse monoclonal | Mouse monoclonal |
| Detection | Bichromatic (577,700 nm)rate measurement | Fluorometric endpointmeasurement |
| 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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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with no facial details. The image is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
Device Name: Cyclosporine (CSA) Flex® reagent cartridge
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.
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
§ 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.