LZI Cotinine II Enzyme Immunoassay
The LZI Cotinine II Enzyme Immunoassay detects cotinine in human urine as an aid in assessing use of or exposure to tobacco products. It is intended for prescription laboratory use with…
The LZI Cotinine II Enzyme Immunoassay detects cotinine in human urine as an aid in assessing use of or exposure to tobacco products. It is intended for prescription laboratory use with automated clinical chemistry analysers, providing qualitative or semiquantitative results at a cutoff of 200 ng/mL.
The ready-to-use kit contains two separately bottled reagents: an antibody and substrate solution and an enzyme-labelled cotinine conjugate. Cotinine in the sample competes for antibody binding, altering enzyme activity and producing a light-absorbance change measured at 340 nm.
Screening and Confirmation
The assay provides a preliminary result. A more specific chemical method, such as chromatography with mass spectrometry, is required for confirmation. Semiquantitative testing supports specimen dilution for confirmation or laboratory quality control.
Who Else Makes It
All of them in Zhejiang. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Hangzhou Biotest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 41 |
Record
| Listed by | LIN-ZHI International, Inc., United States |
|---|---|
| FDA product code | MKU |
| Device type | Enzyme Immunoassay, Nicotine And Nicotine Metabolites |
| Device class | Class 1 |
| Regulation | 21 CFR 862.3220 |
| Establishment | Manufacturer |
| 510(k) | K192299 |
| Record published | 2022-04-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0521 | In distribution | |
| 0520 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DRI Cotinine Assay | Microgenics Corporation | 3 |
| Auto-Lyte | Orasure Technologies, Inc. | 2 |
| DRI Cotinine Low Control | Microgenics Corporation | 1 |
| Kit, MP Cotinine Serum 100 plate | Orasure Technologies, Inc. | 1 |
| Nano-CheckTM Nicotine 500 | Nano-Ditech Corporation | 1 |
| Cotinine Serum 5 Plate Kit | Orasure Technologies, Inc. | 1 |
| AccuSign® Nicotine card | Princeton BioMeditech Corp. | 1 |
| DRI Cotinine High Control | Microgenics Corporation | 1 |
| Cotinine OraSure 100 Plate Kit | Orasure Technologies, Inc. | 1 |
| SureStep™ Urine Test Drug Screen Cassette, Cotinine (COT 200) | Alere San Diego, Inc. | 1 |
| DRI Cotinine Calibrator Kit | Microgenics Corporation | 1 |
| Cotinine OraSure 5 Plate Kit | Orasure Technologies, Inc. | 1 |
Showing 12 of 17. All products under Enzyme Immunoassay, Nicotine And Nicotine Metabolites
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192299 | 2019-11-21 |
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.