DKZ · Enzyme Immunoassay, Amphetamine
Clinical Toxicology · 21 CFR 862.3100 · Class 2
Overview
| Product Code | DKZ |
|---|---|
| Device Name | Enzyme Immunoassay, Amphetamine |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.
Classification Rationale
Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Special Controls
*Classification.* Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Recent Cleared Devices (20 of 225)
Showing 20 most recent of 225 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240670 | DRI Ecstasy Plus Assay | Microgenics Corporation | Oct 30, 2024 | SESE |
| K233019 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx | Hangzhou AllTest Biotech Co., Ltd. | Dec 13, 2023 | SESE |
| K231137 | Xenta Drug Screen Cup, Xenta Drug Screen Dipcard | Xenta Biomedical Science Co., Ltd. | May 19, 2023 | SESE |
| K200363 | Quidel Triage® TOX Drug Screen, 94600 | Quidel Cardiovascular, Inc. | Mar 11, 2020 | SESE |
| K191099 | Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel | Atlas Medical | Oct 3, 2019 | SESE |
| K182719 | Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro | Quidel Cardiovascular, Inc. | Jun 19, 2019 | SESE |
| K182738 | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | Mar 27, 2019 | SESE |
| K180879 | BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use | Shanghai Venture Bio-Tech Co., Ltd. | Dec 14, 2018 | SESE |
| K181945 | QuickScreen Pro Multi Drug Screening Test, Model 9395Z | Phamatech, Inc. | Oct 18, 2018 | SESE |
| K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) | Alfa Scientific Designs, Inc. | Feb 23, 2018 | SESE |
| K161251 | CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests | Hangzhou Clongene Biotech Co., Ltd. | Aug 30, 2016 | SESE |
| K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) | Alfa Scientific Designs, Inc. | Jun 24, 2016 | SESE |
| K152908 | UCP COMPACT DRUG TESTS | Ucp Biosciences, Inc. | May 3, 2016 | SESE |
| K152590 | ACCU NEWS Drug Screening Test Card/Urine Cup | Coretests, Inc. | Apr 15, 2016 | SESE |
| K153465 | AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup) | Assure Tech. (Hangzhou) Co, Ltd. | Mar 31, 2016 | SESE |
| K152269 | Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card) | Healgen Scientific,, LLC | Sep 9, 2015 | SESE |
| K151213 | UCP Drug Test Mini Cups | Ucp Biosciences, Inc. | Aug 21, 2015 | SESE |
| K142855 | Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA) | Omega Laboratories, Inc. | Jul 28, 2015 | SESE |
| K141748 | RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET | Biophor Diagnostics, Inc. | May 20, 2015 | SESE |
| K143500 | Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set | Immunalysis Corporation | Feb 6, 2015 | SESE |
Top Applicants
- Roche Diagnostic Systems, Inc. — 17 clearances
- Syva Co. — 13 clearances
- American Bio Medica Corp. — 9 clearances
- Roche Diagnostics Corp. — 9 clearances
- Ucp Biosciences, Inc. — 9 clearances
