← Product Code [NFT](/productcode/NFT) · K261984

# AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup (K261984)

_Assure Tech., LLC · NFT · Jul 17, 2026 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K261984

## Device Facts

- **Applicant:** Assure Tech., LLC
- **Product Code:** [NFT](/productcode/NFT.md)
- **Decision Date:** Jul 17, 2026
- **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).

## Submission Summary (Full Text)

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# **510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION  
TRIAGE-QUICK REVIEW DECISION MEMORANDUM**

510(k) Number: K261984

This 510(k) was reviewed under the OHT7/OHT8 OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.

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**Source:** [https://fda.innolitics.com/device/K261984](https://fda.innolitics.com/device/K261984)

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