(758 days)
Not Found
No
The summary describes a standard in vitro diagnostic assay using immunoturbidimetry, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The Tacrolimus Assay Kit is an in vitro diagnostic device used for quantitative determination of tacrolimus concentration in human whole blood, intended as an aid in managing patients receiving tacrolimus therapy. It does not directly provide therapy to a patient.
Yes
Explanation: The device is described as an "Assay Kit" used for "quantitative determination of the tacrolimus concentration in human whole blood" and is intended to be used "as an aid in the management of liver and kidney allograft patients." This type of measurement and its use "as an aid in the management" of patients clearly indicates its role in providing information for diagnosis or therapeutic monitoring, which falls under the definition of a diagnostic device. The statement "For In Vitro Diagnostic Use" further confirms this.
No
The device is an in vitro diagnostic assay kit, which includes physical reagents and components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use."
- Nature of the Assay: The device is a "Tacrolimus Assay Kit" used for "quantitative determination of the tacrolimus concentration in human whole blood." This is a classic example of an in vitro test performed on a biological sample (whole blood) outside of the body.
- Methodology: The "Device Description" mentions a "latex-enhanced competitive immunoturbidimetry method," which is a laboratory-based analytical technique.
- Components: The kit consists of "reagents, sample extract and calibrator," which are typical components of an in vitro diagnostic assay.
- Intended Use: The intended use is to "aid in the management of liver and kidney allograft patients receiving tacrolimus therapy," which is a clinical application of laboratory test results.
All these factors strongly indicate that this device is designed and intended for use as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Tacrolimus Assay Kit is used for quantitative determination of the tacrolimus concentration in human whole blood on the Beckman Coulter AU480. It is to be used as an aid in the management of liver and kidney allograft patients receiving tacrolimus therapy.
For In Vitro Diagnostic Use.
Product codes (comma separated list FDA assigned to the subject device)
MLM
Device Description
The Tacrolimus Assay Kit utilizes the latex-enhanced competitive immunoturbidimetry method for quantitative determination of the tacrolimus concentration in human whole blood. The assay consists of reagents, sample extract and calibrator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human whole blood
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For prescription use only.
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)
Analytical studies were performed to evaluate the precision, linearity, assay reportable range, recovery, specificity, and accuracy of the candidate device.
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
§ 862.1678 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.
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January 27, 2023
Shanghai Genext Medical Technology Co., Ltd. % Giselle Zhang Regulatory Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746
Re: K203833
Trade/Device Name: Tacrolimus Assay Kit Regulation Number: 21 CFR 862.1678 Regulation Name: Tacrolimus Test System Regulatory Class: Class II Product Code: MLM Dated: August 19, 2022 Received: August 19, 2022
Dear Giselle Zhang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
| Paula Caposino -S | Digitally signed by Paula Caposino -S |
|---|---|
| Date: 2023.01.27 | |
| 15:31:02 -05'00' |
Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203833
Device Name Tacrolimus Assay Kit
Indications for Use (Describe)
The Tacrolimus Assay Kit is used for quantitative determination of the tacrolimus concentration in human whole blood on the Beckman Coulter AU480. It is to be used as an aid in the management of liver and kidney allograft patients receiving tacrolimus therapy.
For In Vitro Diagnostic Use.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Submission Number: K203833
The following information is provided in accordance with 21 CFR 807.92:
Submitter Information
| Company: | Shanghai Genext Medical Technology
Co., Ltd. | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------|--|
| Address: | Rml101, 11th Floor, Bldg 2,
Pujiang Hi-Tech Plaza, No.2388
Chenhang Road, Minhang District,
Shanghai, China | |
| Contact Name: | Kimmy Zong | |
| Contact Title: | RA Associate Director | |
| Tel: | + 86-13918832180 | |
| Fax: | N/A | |
| Email: | wenwen.zong@genext.com.cn | |
| Regulatory Correspondent | Giselle Zhang | |
| Email: | LST.AUS.ProjectManagement@ul.com | |
| Date Summary Prepared: | January 24, 2023 | |
Name of the Device
| Device Trade Name: | Tacrolimus Assay Kit |
|---|---|
| Common Name: | Tacrolimus Assay Kit |
| Classification Name: | Toxicology |
| Review Panel | Clinical Chemistry (TX) |
| Regulation Number: | 862.1678 |
| Classification: | II |
| Product Code: | MLM |
Intended Use:
Indications for Use:
The Tacrolimus Assay Kit is used for quantitative determination of the tacrolimus concentration in human whole blood on the Beckman Coulter AU480. It is to be used as an aid in the management of liver and kidney allograft patients receiving tacrolimus therapy.
For In Vitro Diagnostic Use.
Reagent:
- Reagent 1 (R1): FK506-protein complex, stored in MES buffer; Preservative: sodium azide. .
- Reagent 2(R2): Latex particles sensitized by anti-FK506 monoclonal antibody, 4-(2-. hydroxyerhyl) piperazine-1-erhaesulfonic acid; Preservative: sodium azide.
Pretreatment Reagent:
-
Sample extractant: Containing methanol and inorganic salt protein denaturant. ●
Calibrator: -
Calibrator: Bovine whole blood solution containing different concentrations of FK506 (the . calibration target list please see the following table); preservative.: sodium azide.
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- The calibrators yield the following concentrations: ●
| Calibrator name | Target value (ng/mL) |
|---|---|
| Calibrator A | 0.0 |
| Calibrator B | 3.0 |
| Calibrator C | 6.0 |
| Calibrator D | 10.0 |
| Calibrator E | 20.0 |
| Calibrator F | 30.0 |
Special Conditions for use statement(s):
-
For prescription use only. ●
Special Instrument Requirements: -
Beckman Coulter AU480. ●
Device Description
The Tacrolimus Assay Kit utilizes the latex-enhanced competitive immunoturbidimetry method for quantitative determination of the tacrolimus concentration in human whole blood. The assay consists of reagents, sample extract and calibrator.
Test Principle
The kit is based on the principle of latex-enhanced competitive immunoturbidimetry method; The sample should be pretreated, and the protein-bound tacrolimus in the whole blood should be extracted for detection before the tacrolimus concentration is determined in the detection process. FK506 in the sample competes with FK506 in the FK506- protein complex in the reagent to bind the anti-FK506 antibody on the surface of the sensitized latex particles. The higher the concentration of FK506 in the sample, the greater the degree to which the latex surface antibody is bound by it, and the lower the latex aggregation extent induced by FK506- protein complex. The turbidity of the reaction system is negatively correlated with the concentration of FK506 in the sample. Therefore, a calibration curve can be established and the concentration of the whole blood sample FK506 can be calculated by measuring the absorbance at 546 nm.
Substantial Equivalence Information
Predicate Device Identification: ARCHITECT TACROLIMUS: MODEL IL 77 (K070820)
Comparison with Predicate:
| Device & Predicate
Device(s): | Candidate Device
K203833 | Predicate Device
K070820 |
|-----------------------------------------------|-----------------------------|---------------------------------------------------------------------------------|
| Device Trade Name | Tacrolimus Assay Kit | ARCHITECT
Tacrolimus Assay |
| General Device
Characteristic Similarities | | |
| Intended Use/Indications
For Use | Same | For the quantitative
determination of
tacrolimus in human
whole blood. |
| Sample pre-treatment | Same | Manual |
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| General Device
Characteristic Differences | Candidate Device
K203833 | Candidate Device
K070820 |
|----------------------------------------------|---------------------------------------------------------------------------|--------------------------------------------------|
| Measuring Range | 1.5 - 30 ng/mL | 2 - 30 ng/mL |
| Methodology | Particle-enhanced
turbidimetric inhibition
immunoassay
(PETINIA) | Chemiluminescent
microparticle
immunoassay |
| Analyzer platform | Beckman Coulter
AU480 analyzer | ARCHITECT i System. |
Summary of Testing:
Analytical studies were performed to evaluate the precision, linearity, assay reportable range, recovery, specificity, and accuracy of the candidate device.
Conclusion:
Tacrolimus Assay Kit has the same indications for use as the predicate device. Any minor differences in the technological characteristics of the subject device when compared to the predicate device have been evaluated through performance testing which demonstrates that the Tacrolimus Assay Kit is substantially equivalent.