510(k) · Cleared
ClearedOralTox Oral Fluid Drug Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Premier Biotech, Inc. · DJC Thin Layer Chromatography, Methamphetamine
Cleared on Feb 2, 2018 as substantially equivalent to K103227 (Branan Medical Corporation, 2012) after a 266-day review. Its family tree reaches back 3 generations to 1992. 3 later devices descend from it.
- Decided
- Feb 2, 2018
- Review
- 266 days
- Class
- Class II
- Product code
- DJC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K924446 (1992). 8 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK924446 Micro-Plate Opiates AssaySolarcare Technologies Corp,Inc. · 1992
- 2 generations backK981341 STC Opiates Micro-Plate Eia (Orasure Application)OraSure Technologies, Inc. · 1998
- 1 generation backK103227 Oratect Oral Fluid Drug Screen DevicesBranan Medical Corporation · 2012
- This deviceK171403 OralTox Oral Fluid Drug TestPremier Biotech, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK181305 OralTox Oral fluid Drug TestPremier Biotech, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK253705 Healgen® Accurate Oral Fluid Drug TestHealgen Scientific,, LLC · 2026
- Descendant · cites it directly · 0 of its ownK240287 LYHER® Oral fluid Multi-Drug Test Kit (Cube)Hangzhou Laihe Biotech Co., Ltd. · 2025
Most influential descendants
Showing 3 of 3 · See all- K181305OralTox Oral fluid Drug TestPremier Biotech, Inc. · 2018 · cites it directly1descendant
- K253705Healgen® Accurate Oral Fluid Drug TestHealgen Scientific,, LLC · 2026 · 2 generations on0descendants
- K240287LYHER® Oral fluid Multi-Drug Test Kit (Cube)Hangzhou Laihe Biotech Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K924446 | Micro-Plate Opiates Assay | Solarcare Technologies Corp,Inc. | 1992 | — |
| −2 | K981341 | STC Opiates Micro-Plate Eia (Orasure Application) | OraSure Technologies, Inc. | 1998 | — |
| −1 | K103227 | Oratect Oral Fluid Drug Screen Devices | Branan Medical Corporation | 2012 | — |
| 0 (this device) | K171403 | OralTox Oral Fluid Drug Test | Premier Biotech, Inc. | 2018 | — |
| +1 | K181305 | OralTox Oral fluid Drug Test | Premier Biotech, Inc. | 2018 | — |
| +2 | K253705 | Healgen® Accurate Oral Fluid Drug Test | Healgen Scientific,, LLC | 2026 | — |
| +1 | K240287 | LYHER® Oral fluid Multi-Drug Test Kit (Cube) | Hangzhou Laihe Biotech Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DJC? 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 DJC device
- #1 K253705 Healgen® Accurate Oral Fluid Drug Testscore 12.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K103227 | Oratect Oral Fluid Drug Screen DevicesSummary page 4…me Immunoassay Phencyclidine Test System Toxicology LDJ 21 CFR, 862.3870 Cannabinoids Test System Toxicology 5. Predicate Devices: K103227 The Oratect Oral Fluid Drug Screen Device 6. Intended Use The OralTox™ Oral Fluid Drug Test is a competitive binding, lateral… | 2012 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
What does this lineage say?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K181305 (Premier Biotech, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K103227.
How does its category compare?
All DJC devicesDJC Thin Layer Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DJC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJC
258in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJC
No recall names DJC since 2007.
Adverse event reports per year · DJC
2in 2018
MAUDE reports naming product code DJC, 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 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 3 | 258 | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The OralTox Oral Fluid Drug Test is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana (THC), Methamphetamine, Opiates and Phencyclidine, in human oral fluid at the cutoff concentrations listed below and their metabolites: Test Calibrator Cutoff (ng/mL) Amphetamine (AMP) d-Amphetamine 50 Cocaine (COC) Benzoylecgonine 20 Marijuana (THC) Delta-9 Tetrahydrocannabinol…
Read the full statement (133 words)
The OralTox Oral Fluid Drug Test is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana (THC), Methamphetamine, Opiates and Phencyclidine, in human oral fluid at the cutoff concentrations listed below and their metabolites:
Test Calibrator Cutoff (ng/mL)
Amphetamine (AMP) d-Amphetamine 50
Cocaine (COC) Benzoylecgonine 20
Marijuana (THC) Delta-9 Tetrahydrocannabinol 40
Methamphetamine (MET) d-Methamphetamine 40
Opiates (OPI) Morphine 40
Phencyclidine (PCP) Phencyclidine 10
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Liquid Chromatography/Mass Spectrometry, Mass Spectrometry (LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171403 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171403: OralTox Oral Fluid Drug Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171403
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026