(247 days)
The CEDIA Mycophenolic Acid Assay is an in vitro diagnostic medical device intended for the quantitative measurement of mycophenolic acid in human plasma using automated clinical chemistry analyzers as an aid in the management of mycophenolic acid therapy in renal and cardiac transplant patients.
The CEDIA Mycophenolic Acid Calibrators are intended for use in the calibration of the CEDIA MPA Assay.
The MAS Mycophenolic Acid Controls are intended for use as assayed quality control material for validation of MPA assays.
The CEDIA Mycophenolic Acid Assay is a homogeneous assay based on the enzyme ()-galactosidase, which has been genetically engineered into two inactive fragments termed enzyme donor (ED) and enzyme acceptor (EA). These fragments spontaneously re-associate to form fully active enzymes that, in assay format, cleave a substrate, generating a color change that can be measured spectrophotometrically.
The assay consists of a set of four reagents: Enzyme Acceptor Buffer, Enzyme Acceptor Reagent, Enzyme Donor Buffer, and Enzyme Donor Reagent. A two-level (Low and High) set of calibrators is used to calibrate the assay. A three-level set of controls (1 through 3) is used for quality control of the assay.
Here's an analysis of the provided text regarding the acceptance criteria and study for the CEDIA Mycophenolic Acid Assay:
This submission is a 510(k) premarket notification for a new in vitro diagnostic (IVD) device, the CEDIA® Mycophenolic Acid Assay. The primary purpose of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. Therefore, the "acceptance criteria" for this submission are not expressed as specific performance thresholds for sensitivity, specificity, etc., as one might find in an AI/software device submission for an imaging modality. Instead, the acceptance criteria are implicitly that the device performs comparably to the predicate device across various technological characteristics. The study presented is a "performance testing" to verify that the device functions as intended and that design specifications have been satisfied, in comparison to the predicate.
Here's the information as requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for an in vitro diagnostic device seeking substantial equivalence to a predicate, the "acceptance criteria" are the functional and performance characteristics of the predicate device that the new device aims to match or be comparable to. The reported "device performance" is how the new device measures up against those characteristics. The document doesn't provide specific quantitative acceptance ranges for parameters like analytical sensitivity or precision, but rather a direct comparison of the characteristics.
| Characteristic | Acceptance Criteria (Predicate Device - Roche Mycophenolic Acid Assay) | Reported Device Performance (CEDIA Mycophenolic Acid Assay) |
|---|---|---|
| Intended Use | Quantitative determination for total mycophenolic acid in human serum or plasma as an aid in the management of mycophenolic acid therapy in renal and cardiac transplant patients. | Quantitative measurement of mycophenolic acid in human plasma using automated clinical chemistry analyzers as an aid in the management of mycophenolic acid therapy in renal and cardiac transplant patients. |
| Test Principle | Enzyme-mimicking assay with MPA concentration inversely proportional to the assay signal (absorbance change). | Enzyme immunoassay with MPA concentration directly proportional to the assay signal (absorbance change). |
| Matrix | Non-hemolyzed human serum or plasma | Human plasma |
| Reagents | Two reagent assay | Two reagent assay |
| Calibrators | Six levels (0, 1, 3, 5, 10, 15 µg/mL) | Two levels (0 and 10 µg/mL) |
| Controls | Liquid serum-based (0.86, 3.40, 11.96 µg/mL) | Liquid plasma-based (1.0, 2.5, 6.0 µg/mL) |
| Assay Range | 0.4 to 15 ug/mL | 0.2 to 10.0 µg/mL |
Conclusion on Acceptance: The document explicitly states: "As summarized, the CEDIA Mycophenolic Acid Assay is substantially equivalent to the Roche Total Mycophenolic Acid assay. Substantial equivalence has been demonstrated through performance testing to verify that the device functions as intended and that design specifications have been satisfied." This indicates that the device met the implicit acceptance criteria of being comparable to the predicate for the purpose of a 510(k) clearance.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size used for the performance testing (test set) or the data provenance (e.g., country of origin, retrospective or prospective). For IVD devices, such studies would typically involve a certain number of patient samples, but this detail is not present in the summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and therefore not provided in the document. For an IVD assay measuring a chemical compound (mycophenolic acid), the "ground truth" is typically established by reference methods (e.g., mass spectrometry, HPLC) or by the performance of the predicate device itself, not by expert human graders or clinicians evaluating images.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided in the document. Adjudication methods like 2+1 or 3+1 are relevant for tasks involving subjective human interpretation (e.g., radiology reads), which is not the case for a quantitative chemical assay.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for imaging devices where multiple human readers interpret cases. For an IVD assay, the comparison is directly between the new assay's quantitative results and those of a predicate device or reference method.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone algorithm/assay in the context of its function, meaning it directly measures mycophenolic acid concentration. The performance testing outlined in the 510(k) (though not detailed here) would be analogous to a "standalone" evaluation of the assay's accuracy, precision, linearity, and other analytical performance characteristics against established laboratory standards or the predicate device. There is no human "in-the-loop" for the measurement process itself, although clinicians use the results in patient management.
7. The Type of Ground Truth Used
The "ground truth" for this type of IVD device is generally established by:
- Comparison to a legally marketed predicate device: The new device's results are compared to the predicate device's results using patient samples.
- Analytical performance studies: This involves assessing parameters like accuracy (recovery), precision (reproducibility), linearity, limit of detection, and interference studies against known standards or reference materials.
- In some cases for quantitative assays, reference methods (e.g., mass spectrometry, HPLC) are considered the "gold standard" for establishing true values.
The provided summary emphasizes substantial equivalence to the predicate device based on "performance testing," suggesting the predicate's results served as a primary reference for comparison.
8. The Sample Size for the Training Set
The provided text does not state the sample size for any "training set." For a traditional IVD assay like this, there isn't typically a "training set" in the machine learning sense. The assay is developed and optimized, and then its performance is validated in studies. If any statistical models or thresholds were optimized during development, those would involve internal R&D data, not a formally defined "training set" as understood in AI/ML contexts.
9. How the Ground Truth for the Training Set Was Established
As there's no explicitly defined "training set" in the AI/ML sense, this information is not applicable and not provided. The development of the assay would have involved standard chemical and biochemical experimentation with known concentrations of mycophenolic acid and other substances to optimize the reagent formulations and reaction conditions.
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510K SUMMARY
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
The assigned 510(k) number is: K081083
COMPANY/CONTACT PERSON
Thermo Fisher Scientific Microgenics Corporation 46360 Fremont Blvd. Fremont, CA 94538
DEC 1 9 2008
Establishment registration No: 2937369
Jack Rogers Manager of Regulatory Affairs Telephone: (317) 610-3823 Fax: (317) 610-0018
DATE PREPARED
November 4, 2008
DEVICE NAME
| Trade Name: | CEDIA® Mycophenolic Acid AssayCEDIA® Mycophenolic Acid CalibratorsMAS® Mycophenolic Acid Controls |
|---|---|
| Common Name: | Mycophenolic Acid Test System |
| Device Classification: | 21 CFR 862.3840 Mycophenolic Acid Test System; Class II21 CFR 862.3200 Clinical Toxicology Calibrator; Class II21 CFR 862.3280 Clinical Toxicology Control Material; Class I |
INTENDED USE
The CEDIA Mycophenolic Acid Assay is an in vitro diagnostic medical device intended for the quantitative measurement of mycophenolic acid in human plasma using automated clinical chemistry analyzers as an aid in the management of mycophenolic acid therapy in renal and cardiac transplant patients.
The CEDIA Mycophenolic Acid Calibrators are intended for use in the calibration of the CEDIA MPA Assay.
The MAS Mycophenolic Acid Controls are intended for use as assayed quality control material for validation of MPA assays
LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCY IS CLAIMED
Roche Total Mycophenolic Acid assay (K063520)
DESCRIPTION OF DEVICE
The CEDIA Mycophenolic Acid Assay is a homogeneous assay based on the enzyme ()-galactosidase, which has been genetically engineered into two inactive fragments termed enzyme donor (ED) and enzyme acceptor (EA). These fragments spontaneously re-associate to form fully active enzymes that, in assay format, cleave a substrate, generating a color change that can be measured spectrophotometrically.
The assay consists of a set of four reagents: Enzyme Acceptor Buffer, Enzyme Acceptor Reagent, Enzyme Donor Buffer, and Enzyme Donor Reagent. A two-level (Low and High) set of calibrators is used to calibrate the assay. A three-level set of controls (1 through 3) is used for quality control of the assay.
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| Comparison | CEDIA Mycophenolic AcidAssay | Predicate Device - RocheMycophenolic Acid Assay |
|---|---|---|
| Intended Use | Quantitative measurement ofmycophenolic acid in humanplasma using automated clinicalchemistry analyzers as an aid inthe management ofmycophenolic acid therapy inrenal and cardiac transplantpatients. | Quantitative determination fortotal mycophenolic acid inhuman serum or plasma as anaid in the management ofmycophenolic acid therapy inrenal and cardiac transplantpatients. |
| Test Principle | Enzyme immunoassay withMPA concentration directlyproportional to the assay signal(absorbance change). | Enzyme-mimicking assay withMPA concentration inverselyproportional to the assay signal(absorbance change). |
| Matrix | Human plasma | Non-hemolyzed human serumor plasma |
| Reagents | Two reagent assay | Two reagent assay |
| Calibrators | Two levels(0 and 10 µg/mL) | Six levels(0, 1, 3, 5, 10, 15 µg/mL) |
| Controls | Liquid plasma-based(1.0, 2.5, 6.0 µg/mL) | Liquid serum-based(0.86, 3.40, 11.96 µg/mL) |
| Assay Range | 0.2 to 10.0 µg/mL | 0.4 to 15 ug/mL |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
CONCLUSION
As summarized, the CEDIA Mycophenolic Acid Assay is substantially equivalent to the Roche Total Mycophenolic Acid assay. Substantial equivalence has been demonstrated through performance testing to verify that the device functions as intended and that design specifications have been satisfied.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wing-like shapes, symbolizing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Thermo Fisher Scientific Microgenics Corporation c/o Mr. Jack Rogers Manager of Regulatory Affairs 46360 Fremont Blvd. Fremont, CA 94538
DEC 1 9 2008
Re: K081083
Trade/Device Name: Cedia Mycophenolic Acid Assay, Mycophenolic Acid Calibrators, Mas Mycophenolic Acid Controls
Regulation Number: 21 CFR 862.3840 Regulation Name: Sirolimus Test System. Regulatory Class: Class II Product Code: OAV, DLJ, LAS Dated: November 11, 2008 Received: November 12, 2008
Dear Mr. Rogers:
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) 276-0490. 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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Indications for Use
510(k) Number (if known): K081083
CEDIA Mycophenolic Acid Assay Device Name:
Indications for Use:
The CEDIA Mycophenolic Acid Assay is an in vitro diagnostic medical device intended for the quantitative measurement of mycophenolic acid in human plasma using automated clinical chemistry analyzers as an aid in the management of mycophenolic acid therapy in renal and cardiac transplant patients.
The CEDIA Mycophenolic Acid Calibrators are intended for use in the calibration of the CEDIA MPA Assay.
The MAS Mycophenolic Acid Controls are intended for use as assayed quality control material for validation of MPA assays.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
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Office of In Vitro Diagnostic Device Evaluation and Safet
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§ 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.