# K121231: Ind Drug Home Multi-Panel Test (2-5) Ind Morphine Home Test

- Pathway: 510(k) (Traditional)
- Applicant: Ind Ndiagnostic, Inc.
- Decided: Jul 30, 2012 after 97 days
- Product code: NGT (Saline, Vascular Access Flush)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The IND Drug Home Test is a rapid chromatographic immunoassay multi-panel or single drug test for the qualitative detection of one or more of the following drugs: Amphetamine, Methamphetamine, Cocaine, Marijuana, and Morphine in human urine. It is intended for over-the-counter use. Drug Name (Code) Cut-off Amphetamine (AMP) 1000 ng/mL Methamphetamine (MET) 1000 ng/mL Cocaine (COC) 300 ng/mL Marijuana (THC) 50 ng/mL Morphine (MOR) 300 ng/mL The test is intended for over-the counter (OTC) use as the first step in a two step process to provide consumers with information concerning the presence or absence of the above stated drugs or metabolites in a urine sample. The test provides only preliminary test results. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GCIMS (Gas Chromatography / Mass Spectrometry) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive. Information regarding confirmatory testing, the second step in the process, is provided in the package labeling.

Source page: https://510kreport.com/device/K121231
Methodology: https://510kreport.com/methodology