(46 days)
IMx® Tacrolimus II (MEIA)
Not Found
No
The description details a homogeneous enzyme immunoassay based on recombinant DNA technology and spectrophotometric measurement. There is no mention of AI, ML, or any computational methods that would suggest their use in the device's operation or analysis.
No
This device is an in vitro diagnostic medical device used to measure tacrolimus levels in blood to aid in managing transplant recipients. It does not directly treat or prevent a disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "The CEDIA® Tacrolimus Assay is an in vitro diagnostic medical device intended for the quantitative determination of tacrolimus in human whole blood...".
No
The device description clearly outlines a chemical assay system involving enzymes, antibodies, and spectrophotometric measurement, indicating a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the CEDIA® Tacrolimus Assay is an "in vitro diagnostic medical device".
- Purpose: The assay is designed to be used in vitro (outside the body) to analyze a human sample (whole blood) for the presence and quantity of tacrolimus.
- Clinical Application: The results are intended to aid in the management of patients, which is a key characteristic of IVDs.
The description of the device and its mechanism further supports its classification as an IVD, as it describes a laboratory test performed on a biological sample.
N/A
Intended Use / Indications for Use
The CEDIA® Tacrolimus Assay is an in vitro diagnostic medical device intended for the quantitative determination of tacrolimus in human whole blood using automated clinical chemistry analyzers as an aid in the management of kidney and liver transplant recipients receiving tacrolimus therapy.
CEDIA® Tacrolimus Calibrators are intended for calibration of the CEDIA® Tacrolimus Assay in whole blood.
Product codes
MLM, JIT
Device Description
The CEDIA® Tacrolimus Assay uses recombinant DNA technology (US Patent No. 4708929) to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ß-galactosidase, which has been genetically engineered into two inactive fragments i.e., enzyme acceptor (EA) and enzyme donor (ED). These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically.
In the assay, analyte in the sample competes with analyte conjugated to one inactive fragment (ED) of ß-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the reassociation of inactive ß-galactosidase fragments, and no active enzyme is formed. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of analyte present in the sample.
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)
IMx® Tacrolimus II (MEIA)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1678 Tacrolimus test system.
(a)
Identification. A tacrolimus test system is a device intended to quantitatively determine tacrolimus 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 tacrolimus.(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.
0
MAR 1 5 2005
Section II
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFRS807 92.
510(k) Number:
Submitter:
Microgenics Corporation 46360 Fremont Blvd Fremont, CA 94538 Telephone: (510)-979-5142 Facsimile: (510) 979-5455
Contact Person:
Lisa Charter Research and Development Supervisor Telephone: (510)-979-5142 Facsimile: (510) 979-5455
Alternate Contact: Candice Betz Manager of Regulatory and Quality Affairs Telephone: (510)-979-5169
Preparation Date:
January 27, 2005
Device Information:
| Proprietary Name: | CEDIA® Tacrolimus Assay |
|---|---|
| Device Description: | Enzyme Immunoassay, Tacrolimus |
| Product Code: | MLM |
| Regulation Number: | 21 CFR§862.1678. |
| Regulatory Class: | Class 2 (special controls) |
Predicate Device(s):
The data and results described herein demonstrate that the CEDIA® Tacrolimus Assay is substantially equivalent to IMx® Tacrolimus II (MEIA) for the quantitative determination of tacrolimus (FK506) concentration in human whole blood as an aid in the management of kidney and liver transplant patients receiving therapy with tacrolimus.
1
Device Description:
The CEDIA® Tacrolimus Assay uses recombinant DNA technology (US Patent No. 4708929) to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ß-galactosidase, which has been genetically engineered into two inactive fragments i.e., enzyme acceptor (EA) and enzyme donor (ED). These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically.
In the assay, analyte in the sample competes with analyte conjugated to one inactive fragment (ED) of ß-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the reassociation of inactive ß-galactosidase fragments, and no active enzyme is formed. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of analyte present in the sample.
Intended Use:
The CEDIA® Tacrolimus Assay is an in vitro diagnostic medical device intended for the quantitative determination of tacrolimus in human whole blood using automated clinical chemistry analyzers as an aid in the management of kidney and liver transplant recipients receiving tacrolimus therapy.
CEDIA® Tacrolimus Calibrators are intended for calibration of the CEDIA® Tacrolimus Assay in whole blood.
Comparison to Predicate Device(s):
The CEDIA® Tacrolimus Assay is substantially equivalent to IMx® Tacrolimus II (MEIA) in its intended use and in for the quantitative determination of tacrolimus (FK-506) concentration as an aid in the management of kidney and liver transplant patients receiving therapy with tacrolimus.
2
| Device
Characteristics | Subject Device
(CEDIA® Tacrolimus Assay) | Predicate Device
Abbott Laboratories IMx®
Tacrolimus II (MEIA) |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The CEDIA® Tacrolimus Assay
is an in vitro diagnostic medical
device intended for the
quantitative determination of
tacrolimus in human whole
blood using automated clinical
chemistry analyzers as an aid
in the management of kidney
and liver transplant recipients
receiving tacrolimus therapy.
CEDIA® Tacrolimus Calibrators
are intended for calibration of
the CEDIA® Tacrolimus Assay
in whole blood. | The IMx® Tacrolimus II assay is
an in vitro reagent system for
the quantitative determination
of tacrolimus and some
metabolites in human whole
blood and as an aid in the
management of liver allograft
patients receiving tacrolimus
therapy.
The IMx® Tacrolimus II
Calibrators are for calibration of
the IMx® analyzer when used
for the quantitative
determination of tacrolimus in
human whole blood. |
| Analyte | Tacrolimus | Tacrolimus |
| Matrix | Whole blood extract | Whole blood extract |
| Calibrator
Form | Liquid | Liquid |
| Calibrator
Level | Two (2) Levels (0 and 30
ng/mL) | Six (6) Levels (0, 3, 6, 12, 20,
and 30 ng/mL) |
| Storage | Reagents are stored at 2°C to
8°C until expiration date.
Calibrators are stored at -20°C
until expiration date. | Reagents are stored at 2°C to
8°C until expiration date.
Calibrators are stored frozen
until expiration date. |
| Stability | Until expiration date noted on
vial label and Package Insert. | Until expiration date noted on
vial label. |
Summary:
The information provided in this pre-market notification demonstrates that the CEDIA® Tacrolimus Assay is substantially equivalent to the IMx® Tacrolimus II assay. The IMx® Tacrolimus II assay is commonly used for determination of tacrolimus concentration in whole blood samples obtained from patients receiving tacrolimus for post-operative management following hepatic transplant. Data and results provided in this premarket notification were collected and prepared, respectively, in accordance with the established guideline, "Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA", dated September 16, 2002. , These data and results amply demonstrate that the CEDIA® Tacrolimus Assay is substantially equivalent to the IMx® Tacrolimus II assay for the quantitative determination of tacrolimus (FK506) in human whole blood using automated clinical chemistry analyzers as an aid in the management of kidney and liver transplant patients receiving therapy with tacrolimus.
CEDIA® is a registered trademark of Roche Diagnostics.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, and three horizontal lines above it.
MAR 15 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Lisa Charter Research and Development Microgenics Corp. 46360 Fremont Blvd Fremont, CA 94538
K050206 Re: Resoleco
Trade/Device Name: CEDIA® Tacrolimus Assay CEDIA® Tacrolimus Calibrators Regulation Number: 21 CFR 862.1678 Regulation Name: Tacrolimus test system Regulatory Class: Class II Product Code: MLM, JIT Dated: January 27, 2005 Received: January 28, 2005
Dear Ms. Charter:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because in and the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to togals) the enactment date of the Medical Device Amendments, or to commerce pror to they 20, 2017, 11:12
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de necs mat have occh require approval of a premarket approval application (PMA). and Cosmetic For , recy that the device, subject to the general controls provisions of the Act. The r ou may, mererors, mains of the Act include requirements for annual registration, listing of general controls provisions gractice, 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 it may be subject to Sach adde 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 ana + Federal statutes and regulations administered by other Federal agencies. You must or any I caeral statues and equirements, 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).
4
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin marketing your intial equivalence of your device to a legally premarket notification. "The PDA Imang of cassification 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, If you desn't specific information actually of your device, please contact the Office of In of questions on the promotion and Safety at (240)276-0484. Also, please note the Vill o Diagnostic Dovies Dranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may obtain other general memational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Jean M. Cooper MS, DVM
Jean M. Cooper, MS, 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
5
SECTION III
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K050206
CEDIA® Tacrolimus Assay Device name: CEDIA® Tacrolimus Calibrators
Indications for Use:
The CEDIA® Tacrolimus Assay is an in vitro diagnostic device intended for use with The CEDIA - Tacrolinius Assay is an the quantitative determination of tacrolimus in a automated cifilioar of charj2019 and liver transplant of kidney and liver transplant recipients receiving tacrolimus therapy.
CEDIA® Tacrolimus Calibrators are intended for calibration of the CEDIA® Tacrolimus Assay in whole blood.
Prescription Use × (Part 21 CFR §801 Subpart D) AND/OR .
Over-the Counter Use (21 CFR §807 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)
Carol C. Benson
Premarket Notification - CEDIA® Tacrolimus Assay Microgenics Corporation
$
49