(247 days)
Not Found
No
The description details a homogeneous enzyme assay based on spectrophotometric measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is an in vitro diagnostic (IVD) medical device intended for quantitative measurement of mycophenolic acid, which aids in managing therapy but is not a therapeutic device itself.
Yes
The "Intended Use / Indications for Use" states that the device is an "in vitro diagnostic medical device intended for the quantitative measurement of mycophenolic acid in human plasma... as an aid in the management of mycophenolic acid therapy". This directly indicates its role in diagnosis and management of patient conditions.
No
The device description clearly outlines a set of four physical reagents (Enzyme Acceptor Buffer, Enzyme Acceptor Reagent, Enzyme Donor Buffer, and Enzyme Donor Reagent), calibrators, and controls, which are all tangible components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The CEDIA Mycophenolic Acid Assay is an in vitro diagnostic medical device intended for the quantitative measurement of mycophenolic acid in human plasma..."
This statement directly identifies the device as an in vitro diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OAV, DLJ, LAS
Device Description
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.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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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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 Assay
CEDIA® Mycophenolic Acid Calibrators
MAS® Mycophenolic Acid Controls |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Mycophenolic Acid Test System |
| Device Classification: | 21 CFR 862.3840 Mycophenolic Acid Test System; Class II
21 CFR 862.3200 Clinical Toxicology Calibrator; Class II
21 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 Acid
Assay | Predicate Device - Roche
Mycophenolic Acid Assay |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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. | 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. |
| Test Principle | Enzyme immunoassay with
MPA concentration directly
proportional to the assay signal
(absorbance change). | Enzyme-mimicking assay with
MPA concentration inversely
proportional to the assay signal
(absorbance change). |
| Matrix | Human plasma | Non-hemolyzed human serum
or 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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