(378 days)
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No
The description details a standard immunoassay technique (PETINIA) and its calibration, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is an in vitro diagnostic test used to measure Mycophenolic acid levels in human plasma, which aids in managing mycophenolic acid therapy, but it does not directly treat or prevent a disease or condition.
Yes
The device is described as an "in vitro diagnostic "test for the quantitative measurement of Mycophenolic acid (MPA) in human plasma." It is used as an aid in the management of mycophenolic acid therapy, which falls under the scope of diagnosis and monitoring for treatment.
No
The device is an in vitro diagnostic test kit consisting of liquid reagents and calibrators, which are physical components used in a clinical chemistry system. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "The Dimension® Mycophenolic Acid Flex® reagent cartridge is an in vitro diagnostic test..." and "The Dimension® Mycophenolic Acid Calibrator is an in vitro diagnostic product...".
- Measurement in Human Samples: The device is designed to measure Mycophenolic acid (MPA) in human plasma. This is a key characteristic of IVDs, which analyze samples taken from the human body.
- Clinical Purpose: The measurements are used "as an aid in the management of mycophenolic acid therapy in renal, hepatic, and cardiac transplant patients." This indicates a clinical purpose for the test results, which is another defining feature of IVDs.
- Laboratory Setting: The description mentions use on the "Dimension® clinical chemistry system," which is a laboratory instrument. IVDs are typically used in a laboratory or clinical setting.
- Methodology: The description of the methodology (homogenous particle enhanced turbidimetric inhibition immunoassay) is consistent with techniques used in IVD tests.
The provided information strongly supports the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Dimension® Mycophenolic Acid Flex® reagent cartridge is an in vitro diagnostic test for the quantitative measurement of Mycophenolic acid (MPA) in human plasma on the Dimension® clinical chemistry system. Measurements of MPA are used as an aid in the management of mycophenolic acid therapy in renal, hepatic, and cardiac transplant patients.
The Dimension® Mycophenolic Acid Calibrator is an in vitro diagnostic product for the calibration of the Mycophenolic Acid method on the Dimension® clinical chemistry system.
Product codes (comma separated list FDA assigned to the subject device)
OAV, DLJ
Device Description
MPAT
The liquid reagents are configured in an eight well "Flex®"; the content of each Flex® well is described in the Instructions for Use.
The methodology for the Dimension® MPAT assay is based on a homogenous particle enhanced turbidimetric inhibition immunoassay (PETINIA) technique, which uses a latex particle mycophenolic acid conjugate (PR) and monoclonal mycophenolic acid specific antibody (Ab). Mycophenolic acid present in the sample competes with the mycophenolic acid on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of mycophenolic acid in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340 nm and 700 nm.
The concentration is determined by means of a mathematical function:
Mycophenolic acid + PR + Ab --------------------------------------------------------------------------------------------------------------------------------------------------(scatters light at 340 nm)
To perform the MPAT assay, a sample cup containing the plasma or serum sample to be analyzed and a Dimension® MPAT reagent Flex® Reagent Cartridge are placed appropriately on the Dimension® analyzer.
Calibrator
The Dimension MPAT Calibrator is used to calibrate the MPAT assay on the Dimension system. The calibrator is a five level aqueous BSA matrix product containing Mycophenolic acid. The typical calibration levels for levels 1 through 5 respectively, are 0.0, 0.7, 2.3, 6.7 and 30.0 µg/mL. Level 1 is a zero level, and can be used to dilute samples that exceed 30 µg/mL.
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)
Split sample comparison between the Dimension® Mycophenolic Acid Flex® Reagent Cartridge and HPLC/LC-MS assays gave the following correlation statistics, when tested with clinical samples from kidney, heart and liver transplant patients:
Reference Method: HPLC/LC-MS
Slope: 1.04
Intercept (µg/mL): -0.02
Correlation Coefficient (r): 0.98
n: 109
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation Coefficient (r): 0.98
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3840 Sirolimus test system.
(a)
Identification. A sirolimus test system is a device intended to quantitatively determine sirolimus concentrations in whole blood. Measurements are used as an aid in management of transplant patients receiving therapy with sirolimus.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Sirolimus Test Systems.” See § 862.1(d) for the availability of this guidance document.
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This 510(k) summary is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Submitter's Name: Helen M. Lee Siemens Healthcare Inc. P.O. Box 6101 Newark, DE 19714-6101 Phone 302.631.8706 Fax 302.631.6299
Date of Preparation: October 6, 2011
Name of Product: 1. Dimension® Mycophenolic Acid Flex® Reagent Cartridge 2. Dimension® Mycophenolic Acid Calibrator
- FDA Classification Name: 1. Immunoassay, Mycophenolic Acid (MPA) 2. Calibrator
Predicate Device:
The following table describes the predicate devices, device classification, regulation and product code associated with this pre-market notification:
| New
Product | Predicate
Device | 510(k)
number | Device
Class | Regulation | Product
Code |
|-----------------------------------------------|----------------------------------------------------------------|------------------|-----------------|--------------------|-----------------|
| Dimension® MPAT
Flex® Reagent
Cartridge | Roche Total MPA assay for
the COBAS INTEGRA
system | K063520 | II | 21 CFR
862.3840 | OAV |
| Dimension® MPAT
Calibrator | Roche Total MPA
Calibrators for the COBAS
INTEGRA system | K063520 | II | 21 CFR
862.3200 | DLJ |
Device Description:
MPAT
The liquid reagents are configured in an eight well "Flex®"; the content of each Flex® well is described in the Instructions for Use.
The methodology for the Dimension® MPAT assay is based on a homogenous particle enhanced turbidimetric inhibition immunoassay (PETINIA) technique, which uses a latex particle
1
mycophenolic acid conjugate (PR) and monoclonal mycophenolic acid specific antibody (Ab). Mycophenolic acid present in the sample competes with the mycophenolic acid on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of mycophenolic acid in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340 nm and 700 nm.
The concentration is determined by means of a mathematical function:
Mycophenolic acid + PR + Ab --------------------------------------------------------------------------------------------------------------------------------------------------(scatters light at 340 nm)
To perform the MPAT assay, a sample cup containing the plasma or serum sample to be analyzed and a Dimension® MPAT reagent Flex® Reagent Cartridge are placed appropriately on the Dimension® analyzer.
Calibrator
The Dimension MPAT Calibrator is used to calibrate the MPAT assay on the Dimension system. The calibrator is a five level aqueous BSA matrix product containing Mycophenolic acid. The typical calibration levels for levels 1 through 5 respectively, are 0.0, 0.7, 2.3, 6.7 and 30.0 µg/mL. Level 1 is a zero level, and can be used to dilute samples that exceed 30 µg/mL.
Intended Use:
MPAT
The MPAT assay is an in vitro diagnostic test for the quantitative measurement of mycophenolic acid (MPA) in human serum and plasma on the Dimension® Clinical Chemistry System. Measurements of MPA are used as an aid in the management of mycophenolic acid therapy in renal, hepatic and cardiac transplant patients.
Calibrator
The MPAT calibrator is an in vitro diagnostic product for the calibration of the Mycophenolic Acid (MPAT) method on the Dimension® clinical chemistry system.
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Comparison to Predicate Device:
Both the Dimension® Mycophenolic Acid Flex® Reagent Cartridge and the predicate Roche Total MPA assay for the COBAS INTEGRA system employ prepackaged reagents for use on automated clinical chemistry test systems. A comparison of the important similarities and differences of these methods is provided in the following table:
| Feature | Dimension® Mycophenolic Acid
Flex® Reagent Cartridge | Roche Total MPA assay for
the COBAS INTEGRA
system |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | in vitro diagnostic use; quantitative
measurement of Mycophenolic Acid
in human serum and plasma as an aid
in the management of MPA therapy
in renal, hepatic and cardiac
transplant patients. | in vitro diagnostic use;
quantitative measurement of
Mycophenolic Acid in human
serum or plasma as an aid in
the management of MPA
therapy in renal and cardiac
transplant patients. |
| Sample Type | EDTA Plasma | Serum, EDTA Plasma |
| Assay Range | 0.2 - 30.0 µg/mL
[0.62 - 93.60 µmol/L] | 0.4 - 15 µg/mL, extendable
with post-dilution to 50 µg/mL |
| Technology | Homogenous particle enhanced
turbidimetric inhibition immunoassay
(PETINIA) technique with the MPA
rate of aggregation inversely
proportional to the MPA
concentration in the sample. | Enzyme-mimicking assay with
MPA concentration inversely
proportional to the formation
of NADH. |
| Detection | Bichromatic turbidimetric readings at
340 nm and 700 nm. | Spectrophotometric readings |
| Sample Size | 5 µL | 3 µL |
| Binding
Protein | monoclonal mycophenolic acid
specific antibody | N/A |
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Both the Dimension® Mycophenolic Acid Calibrator and the predicate Roche Total MPA Calibrators for the COBAS INTEGRA system have similar intended use. A comparison of the important similarities and differences is provided in the following table:
| Feature | Dimension® Mycophenolic Acid
Calibrator | Roche Total MPA Calibrators for
the COBAS INTEGRA system |
|------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Intended
Use | Calibrate MPAT on the
Dimension® clinical chemistry
system | Calibrate MPA on the COBAS
INTEGRA system |
| Analytes | MPA | MPA |
| Matrix | Bovine Serum Albumin | Negative human serum |
| Traceable
to: | Gravimetric preparation | Gravimetric preparation |
| Form | Liquid, stored at 2-8°C | Liquid |
| Volume | Vial containing Level 1 with 5.0
mL and Levels 2-5 have 2.0 mL
per vial. | Levels A- F with 5.0 mL each and
one vial of diluents (10.0 mL) |
| Levels | 5 levels (0, 0.7, 2.3, 6.7, and
30.0 µg/mL) | 6 levels (0, 1, 3, 5, 10, 15 µg/mL) |
Comments on Substantial Equivalence:
Split sample comparison between the Dimension® Mycophenolic Acid Flex® Reagent Cartridge and HPLC/LC-MS assays gave the following correlation statistics, when tested with clinical samples from kidney, heart and liver transplant patients:
| Dimension® | Reference
Method | Slope | Intercept
(µg/mL) | Correlation
Coefficient (r) | n |
|------------|---------------------|-------|----------------------|--------------------------------|-----|
| MPAT | HPLC/
LC-MS | 1.04 | -0.02 | 0.98 | 109 |
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Conclusion:
The Dimension® Mycophenolic Acid Flex® Reagent Cartridge with the associated Dimension® MPAT Calibrator are substantially equivalent in principle and performance to the Roche COBAS INTEGRA system based on the split sample comparison versus HPLC and HPLC/LC-MS reference methods discussed above.
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Image /page/5/Picture/0 description: The image shows a logo with a stylized bird in the center. The bird is composed of three curved lines that suggest wings and a body. The bird is facing to the right. Surrounding the bird is a circular arrangement of text. The text is small and difficult to read, but it appears to be a series of words or phrases. The logo has a simple, clean design.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Siemens Healthcare Diagnostics, Inc. c/o Ms. Helen Lee 500 GBC Drive M/S 514 Newark. DE 19714-6101
OCT - 7 2011
Re: K102772
Trade Name: Dimension®Mycophenolic Acid Flex® reagent cartridge Dimension® Mycophenolic Acid Calibrator Regulation Number: 21 CFR 862.3840 Regulation Name: Sirolimus test system Regulatory Class: Class II Product Code: OAV, DLJ Dated: September 30, 2011 Received: October 4, 2011
Dear Ms. Lee:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Virro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the responing of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 for (1 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/de{autt.html
Sincerely yours,
jz
Courtney H. Lias, 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 Form
510(k) Number (if known): K102772
Device Name: Dimension® Mycophenolic Acid Flex® reagent cartridge
Indications for Use:
The Dimension® Mycophenolic Acid Flex® reagent cartridge is an in vitro diagnostic test for the quantitative measurement of Mycophenolic acid (MPA) in human plasma on the Dimension® clinical chemistry system. Measurements of MPA are used as an aid in the management of mycophenolic acid therapy in renal, hepatic, and cardiac transplant patients.
Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart C) - ,
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) | 02772
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Indications for Use Form
1,02772 510(k) Number (if known): _
Device Name: Dimension® Mycophenolic Acid Calibrator
Indications for Use:
The Dimension® Mycophenolic Acid Calibrator is an in vitro diagnostic product for the calibration of the Mycophenolic Acid method on the Dimension® clinical chemistry system.
Prescription Use X Prescription Use X__________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Rudd Chesler
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 102772
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