Ind Drug Home Multi-Panel Test (2-5) Ind Morphine Home Test
by Ind Ndiagnostic, Inc. 510(k)
Active
510(k) K121231
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK121231 | Date30 Jul 2012 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- NGT
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5200
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a rapid chromatographic immunoassay designed for the qualitative detection of multiple drugs in human urine. It includes a multi-panel test capable of identifying Amphetamine, Methamphetamine, Cocaine, Marijuana, and Morphine, as well as a single-panel test for Morphine. The test is intended for home use and provides results through visual interpretation of a chromatographic strip.
The device is supplied as a single-use, non-sterile diagnostic test intended for use in home settings. It requires no special storage conditions and is regulated under FDA 510(k) clearance (K121231) as a Class II medical device. The test is intended for qualitative use only and does not provide quantitative measurements or clinical diagnosis. No MRI safety considerations apply, as it is not a magnetic resonance imaging-compatible device.
Other devices from Ind Diagnostic, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Ind Ndiagnostic Morphine Home Test used for?
The Ind Ndiagnostic Morphine Home Test is a rapid chromatographic immunoassay designed for the qualitative detection of morphine in human urine. It provides a visual result indicating whether morphine or its metabolites are present, but it does not measure exact quantities or provide a clinical diagnosis. This test is intended for home use to screen for morphine use, not for medical diagnosis or treatment decisions.
How is the Ind Ndiagnostic Morphine Home Test supplied and stored?
The test is supplied as a single-use, non-sterile device. No special storage conditions are required—it can be stored at room temperature until use. Always check the packaging for expiration dates and ensure the test remains in its original, unopened condition before use to maintain accuracy.
Is this test reusable, or is it meant for one-time use?
This device is explicitly designed for single-use only. After performing the test, the cassette or strip should be discarded. Reusing the test could lead to inaccurate results or contamination, compromising its reliability for detecting morphine in urine.
What drugs does the multi-panel version detect, and how does it differ from the Morphine Home Test?
The multi-panel version (IND DRUG HOME MULTI-PANEL TEST) detects amphetamine, methamphetamine, cocaine, marijuana, and morphine, while the Morphine Home Test is a standalone, single-panel test specifically for morphine. Both use the same rapid chromatographic immunoassay technology but differ in their panel scope and intended use.
Does this test require any special handling or preparation before use?
The test is simple to use and does not require special handling beyond following the included instructions. No preparation of the urine sample (like dilution or heating) is needed—just collect a fresh urine sample and apply it to the test cassette as directed. Results are visually interpreted on the chromatographic strip within minutes.