Elecsys Tacrolimus
Elecsys Tacrolimus measures tacrolimus in EDTA human whole blood to assist management of liver and kidney transplant patients receiving the drug. It is an in vitro immunoassay for use with…
Elecsys Tacrolimus measures tacrolimus in EDTA human whole blood to assist management of liver and kidney transplant patients receiving the drug. It is an in vitro immunoassay for use with Elecsys and cobas e immunoassay analyzers.
Tacrolimus in the sample competes with a ruthenium labeled derivative for antibody binding. Streptavidin coated magnetic microparticles capture the reaction complex, and an applied voltage produces light emission that the analyzer measures to calculate concentration.
Sample Preparation
Samples, calibrators and controls require treatment with Elecsys ISD Pretreatment Reagent before testing. This lyses cells, extracts tacrolimus and precipitates blood proteins. After centrifugation, the supernatant is tested using an instrument calibration curve derived from two calibration points and the reagent’s master curve.
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 | Roche Diagnostics Gmbh, Germany |
|---|---|
| FDA product code | MLM |
| Device type | Enzyme Immunoassay, Tracrolimus |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1678 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K173857 |
| Record published | 2019-02-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 07251254190 | In distribution | |
| 05889057160 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Architect | Abbott Ireland Diagnostics | 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 |
| QMS Tacrolimus Immunoassay | Microgenics 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 |
|---|---|
| K173857 | 2018-11-06 |
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.