# K033566: Micromedic Drugs of Abuse Panel Test (9), Catalog Number 07RD-7062

- Pathway: 510(k) (Traditional)
- Applicant: Rapid Diagnostics, Inc.
- Decided: May 17, 2004 after 187 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K051958: MP Rapidoxy Test Strip, Model 07RD-7073 (2006), 1 descendant of its own
- K162395: MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup (2017), 0 descendants of its own

## Indications for use
The MICROMEDIC® Drugs of Abuse Panel Test is an immunochromatographic one-step in-vitro test intended for the qualitative determination of up to nine different drug substances in human urine at the following cut-off levels (amphetamine, 1000 ng/ml; barbiturate [secobarbitall, 300 ng/ml; benzodiazepine loxazepaml, 300 ng/ml; cocaine, 300 ng/ml; methadone, 300 ng/ml; methamphetamine, 1000 ng/ml; opiates, 2000 ng/ml; phencyclidine, 25 ng/ml; and cannabinoid, 50 ng/ml). The MICROMEDIC® Drugs of Abuse Panel Test is intended for use in a point-of-care (POC) setting to include emergency hospitals and medical care facilities (i.e., emergency rooms, ambulances, etc.), as well as the workplace, criminal justice and transportation arenas, and walk-in, or mobile drug testing facilities. The MICROMEDIC® Drugs of Abuse Panel Test will provide a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. It is the responsibility of those organizations required to follow Department of Transportation (DOT) or the Substance Abuse and Mental Health Administration (SAMHSA) Workplace Drug Testing Guidelines to determine that use of this product satisfies the criteria for workplace testing established under DOT and SAMHSA.

Source page: https://510kreport.com/device/K033566
Methodology: https://510kreport.com/methodology