Revised Labeling for ADX Amphetamine/Methampheta
by Abbott Laboratories 510(k)
Active
510(k) K880013
Overview
This is an enzyme immunoassay device for the detection of amphetamine. It is a Class II medical device designed for clinical toxicology applications.
The device is manufactured by Abbott Laboratories and received FDA 510(k) clearance with number K880013 on March 1, 1988. It is regulated under product code DKZ and regulation number 862.3100. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK880013 | Date1 Mar 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DKZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3100
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the ADX Amphetamine/Methamphet device used for?
This device is an enzyme immunoassay designed for the detection of amphetamine in clinical toxicology applications. It helps laboratories identify amphetamine presence in patient samples for diagnostic purposes.
Is the ADX Amphetamine/Methamphet device single-use or reusable?
The device information does not specify whether it is designed for single-use or reusable applications. This detail should be confirmed in the product labeling or by contacting the manufacturer directly for specific usage instructions.
What regulatory approvals does the ADX Amphetamine/Methamphet device have?
The device received FDA 510(k) clearance with number K880013 on March 1, 1988. It is classified as a Class II medical device under product code DKZ and regulation number 862.3100, designed for clinical toxicology applications.
Are there different models or sizes available for the ADX Amphetamine/Methamphet device?
The device data does not specify different models or sizes. The information provided refers to a single device type for amphetamine detection. For specific model variations, additional product information would be required.