← Product Code [DKZ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ) · K983770

# 'RAPID DRUG SCREEN' 9-PANEL (K983770)

_American Bio Medica Corp. · DKZ · Dec 31, 1998 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K983770

## Device Facts

- **Applicant:** American Bio Medica Corp.
- **Product Code:** [DKZ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ.md)
- **Decision Date:** Dec 31, 1998
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3100
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory 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.

## 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).

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K983770](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K983770)

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