← Product Code [DJG](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJG) · K011353

# ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE (K011353)

_ACON Laboratories, Inc. · DJG · Jul 30, 2001 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJG/K011353

## Device Facts

- **Applicant:** ACON Laboratories, Inc.
- **Product Code:** [DJG](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJG.md)
- **Decision Date:** Jul 30, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3650
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

## Special Controls

*Classification.* Class II (special controls). An opiate 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/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJG/K011353](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJG/K011353)

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