Cedia Methamphatemine OFT Assay
The CEDIA Methamphetamine OFT Assay screens oral fluid for methamphetamine in a clinical laboratory. It is performed on the MGC 240 and uses a cutoff of 120 ng/mL in undiluted oral fluid.…
The CEDIA Methamphetamine OFT Assay screens oral fluid for methamphetamine in a clinical laboratory. It is performed on the MGC 240 and uses a cutoff of 120 ng/mL in undiluted oral fluid. Specimens must be collected with the Oral-Eze Saliva Collection System.
The homogeneous enzyme immunoassay uses two inactive fragments of beta-galactosidase. Methamphetamine in the sample competes with an enzyme-fragment conjugate for antibody binding. When sample drug binds the antibody, the fragments can rejoin to form active enzyme, producing a measurable color change.
Result and Setting
The assay is for professional laboratory use and is not intended for point-of-care testing. Results are preliminary and require confirmation by a more specific method, preferably gas chromatography/mass spectrometry or liquid chromatography with tandem mass spectrometry.
Who Else Makes It
Concentrated in Zhejiang (4), Guangdong (2), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Abon Biopharm (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 17 |
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 44 |
| W.h.p.m. Bioresearch & Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 37 |
| Changchun Wancheng BIO-Electron Co., Ltd. | Changchun | Jilin | Contract manufacturer | 34 |
| Co-Innovation Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 29 |
| Hongkong Conlight Medical Group Limited | Tai Kok Tsui | Hong Kong | Specification developer | 11 |
| Nantong Egens Biotechnology Co., Ltd. | Nantong | Jiangsu | Manufacturer | 7 |
Record
| Listed by | Microgenics Corporation, United States |
|---|---|
| FDA product code | LAF |
| Device type | Gas Chromatography, Methamphetamine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3610 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K101753 |
| Record published | 2016-09-21 |
| 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 |
|---|---|---|
| 10014949 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| iScreen™ | Instant Technologies, Inc. | 52 |
| DrugCheck | Express Diagnostics Int’l., Inc. | 27 |
| Gas Chromatography, Methamphetamine | W.h.p.m., Inc. | 25 |
| iCup™ | Instant Technologies, Inc. | 19 |
| MD DugScreen | Medical Disposables Corp | 18 |
| DrugCheck | Express Diagnostic Int’l, Inc. | 9 |
| Healgen | Healgen Scientific Limited Liability Company | 8 |
| Statdip® | Micro Distributing, L.C | 8 |
| ProScreen | Instant Tech Subsidiary Acquisition | 6 |
| QuickProfile™ Drugs of Abuse Test Cup | Lumiquick Diagnostics, Inc. | 5 |
| First Sign® | Hemosure Inc. | 5 |
| Generic | Chemtron Biotech, Inc. | 5 |
Showing 12 of 76. All products under Gas Chromatography, Methamphetamine
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K101753 | 2011-04-08 |
| K010496 | 2001-05-29 |
| K904413 | 1990-11-05 |
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.