510(k) · Cleared
ClearedHealgen® Accurate Oral Fluid Drug Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healgen Scientific,, LLC · DJC Thin Layer Chromatography, Methamphetamine
Cleared on Mar 16, 2026 as substantially equivalent to K181305 (Premier Biotech, Inc., 2018) after a 112-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Mar 16, 2026
- Review
- 112 days
- Class
- Class II
- Product code
- DJC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K924446 (1992). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK924446 Micro-Plate Opiates AssaySolarcare Technologies Corp,Inc. · 1992
- 4 generations backK981341 STC Opiates Micro-Plate Eia (Orasure Application)OraSure Technologies, Inc. · 1998
- 3 generations backK103227 Oratect Oral Fluid Drug Screen DevicesBranan Medical Corporation · 2012
- 2 generations backK171403 OralTox Oral Fluid Drug TestPremier Biotech, Inc. · 2018
- 1 generation backK181305 OralTox Oral fluid Drug TestPremier Biotech, Inc. · 2018
- This deviceK253705 Healgen® Accurate Oral Fluid Drug TestHealgen Scientific,, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K924446 | Micro-Plate Opiates Assay | Solarcare Technologies Corp,Inc. | 1992 | — |
| −4 | K981341 | STC Opiates Micro-Plate Eia (Orasure Application) | OraSure Technologies, Inc. | 1998 | — |
| −3 | K103227 | Oratect Oral Fluid Drug Screen Devices | Branan Medical Corporation | 2012 | — |
| −2 | K171403 | OralTox Oral Fluid Drug Test | Premier Biotech, Inc. | 2018 | — |
| −1 | K181305 | OralTox Oral fluid Drug Test | Premier Biotech, Inc. | 2018 | — |
| 0 (this device) | K253705 | Healgen® Accurate Oral Fluid Drug Test | Healgen Scientific,, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 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 K240287 LYHER® Oral fluid Multi-Drug Test Kit (Cube)score 9.9 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K181305 | OralTox Oral fluid Drug TestSummary page 5…cology DJR 21 CFR, 862.3610 Methadone Test System Toxicology 5. Predicate Devices: Premier Biotech OralTox® Oral Fluid Drug Test, K181305 6. Intended Use The Healgen® Accurate Oral Fluid Drug Test is a competitive binding lateral flow immunochromatographic as… | 2018 |
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.
What does this lineage say?
- The line of descent spans 34 years and passes through 5 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 10 ancestors has a recall of any class.
How does its category compare?
All DJC devicesDJC Thin Layer Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Healgen® Accurate Oral Fluid Drug Test is a competitive binding lateral flow immunochromatographic assay for the qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana, Methadone, Methamphetamine, Opiates, Oxycodone, 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)…
Read the full statement (149 words)
The Healgen® Accurate Oral Fluid Drug Test is a competitive binding lateral flow immunochromatographic assay for the qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana, Methadone, Methamphetamine, Opiates, Oxycodone, 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
Methadone (MTD) Methadone 30
Methamphetamine (MET) d-Methamphetamine 50
Opiates (OPI) Morphine 40
Oxycodone (OXY) Oxycodone 20
Phencyclidine (PCP) Phencyclidine 10
The test provides only preliminary test results. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Liquid Chromatography/Mass Spectrometry/ Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. It is not intended to distinguish between prescription use or abuse of the drug. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
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/K253705 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253705: Healgen® Accurate Oral Fluid Drug Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253705
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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