510(k) · Cleared
ClearedInd Drug Home Multi-Panel Test (2-5) Ind Morphine Home Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ind Ndiagnostic, Inc. · NGT Saline, Vascular Access Flush
Cleared on Jul 30, 2012 after a 97-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 30, 2012
- Review
- 97 days
- Class
- Class II
- Product code
- NGT
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NGT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NGT device
- #1 K250884 0.9 % Sodium Chloride Injection, USP, BD…score 11.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All NGT devicesNGT Saline, Vascular Access Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · NGT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NGT
142in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NGT
1in 2025
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · NGT
212in 2025
MAUDE reports naming product code NGT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 2 | 31 |
| 2008 | 1 | — | 0 | 64 |
| 2009 | 1 | — | 1 | 18 |
| 2010 | 2 | — | 7 | 23 |
| 2011 | 3 | 219 | 1 | 20 |
| 2012 | 4 | 106 | 1 | 5 |
| 2013 | 1 | — | 1 (1) | 25 |
| 2014 | 3 | 87 | 0 | 25 |
| 2015 | 1 | — | 0 | 14 |
| 2016 | 1 | — | 1 (1) | 82 |
| 2017 | 2 | — | 0 | 56 |
| 2018 | 1 | — | 0 | 270 |
| 2019 | 2 | — | 2 | 340 |
| 2020 | 2 | — | 0 | 322 |
| 2021 | 0 | — | 1 (1) | 566 |
| 2022 | 3 | 151 | 1 | 282 |
| 2023 | 6 | 142 | 3 (2) | 313 |
| 2024 | 1 | — | 0 | 332 |
| 2025 | 1 | — | 1 | 212 |
| 2026 | 0 | — | 1 (1) | — |
What is it indicated for?
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…
Read the full statement (178 words)
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K121231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121231: Ind Drug Home Multi-Panel Test (2-5) Ind Morphine Home Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121231
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026