(475 days)
P890025
Abbott TDx 77DxFLx® Cyclosporine Monoclonal Whole Blood assay, P890025
No
The summary describes a standard immunoassay technology and does not mention any AI or ML components.
No.
The device is an in vitro diagnostic immunoassay that quantifies cyclosporine levels in blood, providing information for managing therapy, but it does not directly provide therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The ADVIA Centaur Cyclosporine assay is an in vitro diagnostic immunoassay". This directly labels the device as diagnostic.
No
The device description clearly outlines a competitive immunoassay using physical reagents (Lite Reagent, biotin-labeled monoclonal mouse anti-cyclosporine antibody, streptavidin coupled to paramagnetic particles) and a manual sample pretreatment process. This indicates a hardware-dependent in vitro diagnostic system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The ADVIA Centaur Cyclosporine assay is an in vitro diagnostic immunoassay for the quantitative determination of cyclosporine in human whole blood using the ADVIA Centaur systems."
This statement directly identifies the device as an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The ADVIA Centaur® Cyclosporine assay is an in vitro diagnostic immunoassay for the quantitative determination of cyclosporine in human whole blood using the ADVIA Centaur systems. This assay is intended for use as an aid in the management of cyclosporine therapy in kidney, heart, and liver transplant patients.
The ADVIA Centaur® Cyclosporine Calibrator is for in vitro diagnostic use in the calibration of the Cyclosporine assay on the ADVIA Centaur® system.
Product codes
MKW, DLJ
Device Description
The ADVIA Centaur® Cyclosporine assay is a competitive immunoassay using direct chemiluminescent technology. Cyclosporine in the patient sample competes with acridinium ester-labeled cyclosporine in the Lite Reagent for a limited amount of biotin-labeled monoclonal mouse anti-cyclosporine antibody. Biotinlabeled anti-cyclosporine binds to streptavidin that is covalently coupled to paramagnetic particles in the Solid Phase. In the ADVIA Centaur® Cyclosporine assay the sample is manually pretreated to lyse the cells and solubilize the cyclosporine.
An inverse relationship exists between the amount of cyclosporine present in the patient sample and the amount of relative light units (RLUs) detected by the system.
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
Method comparison studies were conducted at three external sites comparing the ADVIA Centaure Cyclosporine assay against two predicates:
- Tandem Mass Spectrometry, and
- The Abbott TDx 77DxFLx® Cyclosporine Monoclonal Whole Blood assay.
Samples from three transplant patient groups (heart, kidney and liver) were used in the studies. The data from all three sites were analyzed by Deming regression.
Number of Patient Samples:
- Tandem-MS: kidney (108), liver (75), heart (67), all (250)
- Tandem-MS (by site): site 1 (97), site 2 (105), site 3 (48), all (250)
- Abbott TDx (by site): site 1 (97), site 2 (97), site 3 (48), all (242)
- Abbott AxSym: site 1 (219)
- Tandem-MS (trough, peak): trough (182), peak (68), all (250)
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method comparison studies were conducted at three external sites comparing the ADVIA Centaure Cyclosporine assay against two predicates: Tandem Mass Spectrometry and the Abbott TDx 77DxFLx® Cyclosporine Monoclonal Whole Blood assay. Samples from three transplant patient groups (heart, kidney and liver) were used in the studies. The data from all three sites were analyzed by Deming regression.
Key Results (Slopes, Intercepts, Correlation Coefficients):
Tandem-MS vs. ADVIA Centaur® Cyclosporine assay:
- kidney: Slope 1.11, Intercept -8, Correlation Coefficient 0.962
- liver: Slope 1.04, Intercept -5, Correlation Coefficient 0.967
- heart: Slope 0.89, Intercept 20, Correlation Coefficient 0.966
- all: Slope 1.03, Intercept -1, Correlation Coefficient 0.963
Tandem-MS vs. ADVIA Centaur® Cyclosporine assay (by site):
- site 1: Slope 0.88, Intercept 13, Correlation Coefficient 0.979
- site 2: Slope 0.85, Intercept 23, Correlation Coefficient 0.988
- site 3: Slope 1.11, Intercept 46, Correlation Coefficient 0.965
- all: Slope 0.94, Intercept 19, Correlation Coefficient 0.960
Abbott TDx vs. ADVIA Centaur® Cyclosporine assay (by site):
- site 1: Slope 0.78, Intercept 8, Correlation Coefficient 0.977
- site 2: Slope 0.68, Intercept -3, Correlation Coefficient 0.988
- site 3: Slope 0.71, Intercept 22, Correlation Coefficient 0.977
- all: Slope 0.72, Intercept 6, Correlation Coefficient 0.977
Abbott AxSym vs. ADVIA Centaur® Cyclosporine assay:
- site 1: Slope 0.68, Intercept 18, Correlation Coefficient 0.960
Tandem-MS vs. ADVIA Centaur® Cyclosporine assay (trough/peak):
- trough: Slope 1.02, Intercept 8, Correlation Coefficient 0.909
- peak: Slope 1.15, Intercept -104, Correlation Coefficient 0.898
- all: Slope 1.03, Intercept -1, Correlation Coefficient 0.963
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Abbott TDx 77DxFLx® Cyclosporine Monoclonal Whole Blood assay, P890025
Reference Device(s)
Not Found
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.
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SEP 1 1 2008
510(k) Summary ADVIA Centaur® Cyclosporine Assay
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: ______________________________________________________________________________________________________________________________________________________________________________
1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation
Submitter:
Siemens Healthcare Diagnostics 511 Benedict Avenue Tarrytown, New York 10591-5097
Contact Information:
Mary Seeger, Ph.D. Phone: 914-524-2908 Fax : 914-524-2500
Date of Preparation:
August 19, 2008
2. Device Name / Classification
:
Common Name: Cyclosporine Trade Name: ADVIA Centaur® Cyclosporine Assay ADVIA Centaur® Cyclosporine Calibrator FDA Classification: Sec. 862.1235, 862.3200 Cyclosporine Test system - Class II Special controls Clinical Toxicology Calibrator
3. Identification of the Predicate Devices
Abbott TDx 77DxFLx® Cyclosporine Monoclonal Whole Blood assay, P890025
4. Device Description
The ADVIA Centaur® Cyclosporine assay is a competitive immunoassay using direct chemiluminescent technology. Cyclosporine in the patient sample competes with acridinium ester-labeled cyclosporine in the Lite Reagent for a limited amount of biotin-labeled monoclonal mouse anti-cyclosporine antibody. Biotinlabeled anti-cyclosporine binds to streptavidin that is covalently coupled to paramagnetic particles in the
1
Solid Phase. In the ADVIA Centaur® Cyclosporine assay the sample is manually pretreated to lyse the cells and solubilize the cyclosporine.
An inverse relationship exists between the amount of cyclosporine present in the patient sample and the amount of relative light units (RLUs) detected by the system.
5. Device Intended Use
The ADVIA Centaur® Cyclosporine assay is an in vitro diagnostic immunoassay for the quantitative determination of cyclosporine in human whole blood using the ADVIA Centaur systems. This assay is intended for use as an aid in the management of cyclosporine therapy in kidney, heart, and liver transplant patients.
The ADVIA Centaur® Cyclosporine Calibrator is for in vitro diagnostic use in the calibration of the Cyclosporine assay on the ADVIA Centaur® system.
6. Comparison to Predicate Devices
The ADVIA Centaur® Cyclosporine assay is substantially equivalent to Abbott TDx 9TDxFLx® Cyclosporine Monoclonal Whole Blood assay in that:
- Both are immunoassays intended for use in the quantitative measurement of cyclosporine in human . whole blood.
- Both assays use mouse monoclonal antibody .
- . Both assays require pretreatment of patient samples.
The ADVIA Centaur® Cyclosporine assay and Abbott TDx®TDxFLx® Cyclosporine Monoclonal Whole Blood assay differ in that:
- The ADVIA Centaur® Cyclosporine assay does not require whole blood precipitation reagent before . testing.
- . The ADVIA Centaur® Cyclosporine assay does not require pretreatment of calibrators.
Comparison Information
Method comparison studies were conducted at three external sites comparing the ADVIA Centaure Cyclosporine assay against two predicates:
- . Tandem Mass Spectrometry, and
- The Abbott TDx 77DxFLx® Cyclosporine Monoclonal Whole Blood assay. .
2
| Samples from three transplant patient groups (heart, kidney and liver) were used in the studies. The data |
|---|
| from all three sites were analyzed by Deming regression. |
| Comparative
Method | Transplant
Type | Number of
Patient
Samples | Slope | Intercept | Correlation
Coefficient |
|-----------------------|--------------------|---------------------------------|-------|-----------|----------------------------|
| Tandem-MS | kidney | 108 | 1.11 | -8 | 0.962 |
| Tandem-MS | liver | 75 | 1.04 | -5 | 0.967 |
| Tandem-MS | heart | 67 | 0.89 | 20 | 0.966 |
| Tandem-MS | all | 250 | 1.03 | -1 | 0.963 |
:
:
| Comparative
Method | Site | Number of
Patient
Samples | Slope | Intercept | Correlation
Coefficient |
|-----------------------|--------|---------------------------------|-------|-----------|----------------------------|
| Tandem-MS | site 1 | 97 | 0.88 | 13 | 0.979 |
| Tandem-MS | site 2 | 105 | 0.85 | 23 | 0.988 |
| Tandem-MS | site 3 | 48 | 1.11 | 46 | 0.965 |
| Tandem-MS | all | 250 | 0.94 | 19 | 0.960 |
| Abbott TDx | site 1 | 97 | 0.78 | 8 | 0.977 |
| Abbott TDx | site 2 | 97 | 0.68 | -3 | 0.988 |
| Abbott TDx | site 3 | 48 | 0.71 | 22 | 0.977 |
| Abbott TDx | all | 242 | 0.72 | 6 | 0.977 |
| Abbott AxSym | site 1 | 219 | 0.68 | 18 | 0.960 |
:
| Comparative
Method | Site | Number of
Patient
Samples | Slope | Intercept | Correlation
Coefficient |
|-----------------------|--------|---------------------------------|-------|-----------|----------------------------|
| Tandem-MS | trough | 182 | 1.02 | 8 | 0.909 |
| | peak | 68 | 1.15 | -104 | 0.898 |
| | all | 250 | 1.03 | -1 | 0.963 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The image is in black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 1 2008
Siemens Medical Solutions Diagnostics c/o Dr. Mary Sceger Manager Regulatory Affairs 511 Benedict Avenue Tarrytown, NY 10591
Re: K071455
Trade/Device Name: Advia Centaur® Cyclosporine Assay and Advia Centaur® Cyclosporine Calibrator Regulation Number: 21 CFR 862.1235 Regulation Name: Cyclosporine Test System. Regulatory Class: Class II Product Code: MKW, DLJ Dated: September 3, 2008 Received: September 4, 2008
Dear Dr. Seeger:
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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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.
Yean 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
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Indication for Use
510(k) Number (if known): K071455
Device Name: ADVIA Centaur Cyclosporine Assay and Calibrators
Indication For Use: The ADVIA Centaur Cyclosporine assay is an in vitro diagnostic immunoassay for the quantitative determination of cyclosporine in human whole blood using the ADVIA Centaur systems. This assay is intended for use as an aid in the management of cyclosporine therapy in kidney, heart, and liver transplant patients.
Prescription Use (21 CFR Part 801 Subpart D)
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
C
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K071455