QMS Tacrolimus Immunoassay
The QMS Tacrolimus Immunoassay measures tacrolimus in human whole blood on automated clinical chemistry analyzers. Clinical laboratories use the result to aid management of kidney, liver…
The QMS Tacrolimus Immunoassay measures tacrolimus in human whole blood on automated clinical chemistry analyzers. Clinical laboratories use the result to aid management of kidney, liver and heart transplant patients receiving tacrolimus therapy. The assay’s measurement range is 1.0 to 30.0 ng/ml.
Tacrolimus in the sample competes with tacrolimus-coated microparticles for antibody binding sites. Antibody normally causes the particles to agglutinate; sample drug inhibits that reaction. The analyzer measures the resulting rate of absorbance change photometrically, with slower agglutination corresponding to higher drug concentrations.
Reagents
The separately packaged liquid reagents comprise an anti-tacrolimus antibody reagent, a tacrolimus-coated microparticle reagent and a zinc sulfate extraction reagent. They are supplied ready to use and stored at 2 to 8 degrees Celsius.
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Yunze Biotechnology Co., Ltd. | Minhang Disctrict | Shanghai | Manufacturer | 1 |
Record
| Listed by | Microgenics Corporation, United States |
|---|---|
| FDA product code | MLM |
| Device type | Enzyme Immunoassay, Tracrolimus |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1678 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K123343 |
| Record published | 2016-09-22 |
| Record revised | 2019-06-05 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10015556 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Architect | Abbott Ireland Diagnostics | 2 |
| Elecsys Tacrolimus | Roche Diagnostics Gmbh | 2 |
| Alinity | Abbott Ireland Diagnostics | 2 |
| Dimension® Flex® reagent cartridge TAC | Siemens Healthcare Diagnostics Inc | 1 |
| Syva® Emit® 2000 Tacrolimus Assay | Siemens Healthcare Diagnostics Inc | 1 |
| MassTrak™ | Waters Corporation | 1 |
| Alinity-Architect | Abbott Laboratories | 1 |
| Atellica CH Tacr | Siemens Healthcare Diagnostics Inc | 1 |
| Dimension® Flex® reagent cartridge Tacr | Siemens Healthcare Diagnostics Inc | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K123343 | 2013-07-11 |
| K050206 | 2005-03-15 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Microgenics Corporation | 510(k) number | 2022-01-20 | Class II | Process control | Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in over-quantitation in tacrolimus patient result values when used with the QMS Tacrolimus Immunoassay. | 615 kits |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P970007 | 2002-09-05 | IMX TACROLIMUS II | Abbott Laboratories |
| P970025 | 1999-04-27 | PRO-TRAC II TACROLIMUS ELISA KIT | Diasorin Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.