Immutest Drugs of Abuse Screen Device
The ImmuTest AMP, MET and THC screen is a professional-use urine test for preliminary detection of amphetamine, methamphetamine and a marijuana metabolite. It provides a visual, qualitative…
The ImmuTest AMP, MET and THC screen is a professional-use urine test for preliminary detection of amphetamine, methamphetamine and a marijuana metabolite. It provides a visual, qualitative result rather than measuring the amount of drug present.
Lateral-flow test strips produce a test line when the target substance is below the assay’s cutoff. Absence of that line indicates a preliminary positive result. A control line must appear regardless of whether the drug is present, confirming that the test has run.
Listed Item
Immutest AMP+MET+THC
Confirmation
A preliminary result requires clinical consideration and professional judgment. A more specific chemical method is needed for confirmation, with gas or liquid chromatography combined with mass spectrometry identified as the preferred methods.
Who Else Makes It
Concentrated in Zhejiang (9), Guangdong (3), Beijing (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Biotest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 41 |
| Abon Biopharm (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 17 |
| Core Technology Co., Ltd. | Changping District | Beijing | Contract manufacturer | 14 |
| Prometheus Bio Inc. | Hangzhou | Zhejiang | Contract manufacturer | 12 |
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Assure Tech. (Hangzhou) 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 |
| Guangzhou Decheng Biotechnology Co., Ltd. | Guangzhou | Guangdong | Complaint-file establishment | 35 |
| Changchun Wancheng BIO-Electron Co., Ltd. | Changchun | Jilin | Contract manufacturer | 34 |
| Co-Innovation Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 29 |
Showing 12 of 16. All 16 manufacturers in China registered for Enzyme Immunoassay, Amphetamine
Record
| Listed by | Ameditech, Inc., United States |
|---|---|
| FDA product code | DKZ |
| Device type | Enzyme Immunoassay, Amphetamine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3100 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K113046 |
| Record published | 2017-05-01 |
| Record revised | 2023-11-14 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C; Handling environment temperature 15 to 30 °C |
| Distribution end date | 2020-10-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IMD-3AMJ | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Healgen | Healgen Scientific Limited Liability Company | 69 |
| First Sign® | Hemosure Inc. | 39 |
| DrugCheck | Express Diagnostic Int’l, Inc. | 38 |
| DrugCheck | Express Diagnostics Int’l., Inc. | 21 |
| Advin Multi-Drug Screen Test | Advin Biotech, Inc. | 17 |
| T-Square | Wondfo USA Co., Ltd. | 15 |
| Enzyme Immunoassay, Amphetamine | W.h.p.m., Inc. | 15 |
| Statcup® II | Micro Distributing, L.C | 12 |
| MD DugScreen | Medical Disposables Corp | 12 |
| QuickProfile™ Drugs of Abuse Test Cup | Lumiquick Diagnostics, Inc. | 11 |
| Noble Drug Test Cup (Urine) | Noble Medical Inc | 10 |
| ECO II Cup ® | W.h.p.m., Inc. | 10 |
Showing 12 of 223. All products under Enzyme Immunoassay, Amphetamine
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K113046 | 2011-11-10 |
| K053175 | 2005-12-08 |
| K050186 | 2005-03-04 |
| K040092 | 2004-03-08 |
| K012484 | 2001-11-30 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ameditech, Inc. | 510(k) number | 2014-09-23 | Class II | Labeling Change Control | Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on the card cap graphic in the package insert. | 400 kits | 2015-02-27 |
| Ameditech, Inc. | 510(k) number | 2014-09-23 | Class II | Labeling Change Control | Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on the card cap graphic in the package insert. | 80 kits | 2015-02-27 |
| Ameditech, Inc. | 510(k) number | 2014-09-23 | Class II | Labeling Change Control | Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on the card cap graphic in the package insert. | 320 kits | 2015-02-27 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-08-18 | Class II | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. | 99,900 units | 2024-09-30 |
| 2020-08-18 | Class II | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. | 41,340 units | 2024-09-30 |
| 2020-08-18 | Class II | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. | 537,120 units | 2024-09-30 |
| 2011-06-07 | Not classified | Packaging process control | The recall was initiated because Ameditech, Inc. received a complaint from US Diagnostics (USD) that First Check Drug Screen Cups were packaged in the ProScreen Cup boxes. Some of US Diagnostics’ customers received ProScreen 5-panel cups t | 2000 test cups (800 kits) | 2012-01-18 |
| 2011-04-26 | Not classified | Process control | The recall was initiated because Ameditech’s internal review of regulatory files found that the two affected lots were manufactured without proper regulatory clearance. | 6000 test cards (120 kits) | 2011-08-11 |
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.