510(k) · Cleared
ClearedHealgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healgen Scientific,, LLC · DJG Enzyme Immunoassay, Opiates
Cleared on Aug 15, 2025 as substantially equivalent to K240124 (Vivachek Biotech (Hangzhou) Co., Ltd., 2024) after a 50-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Aug 15, 2025
- Review
- 50 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K001178 (2000). 8 ancestors in all, the oldest K973547 (1998). No later device cites it as a predicate yet.
- Root · 7 generations backK001178 Cedia Dau 6-Acetylmorphine AssayMicrogenics Corp. · 2000
- 6 generations backK040316 Cedia Buprenorphine AssayMicrogenics Corp. · 2004
- 5 generations backK150606 Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug…Siemens Healthcare Diagnostics, Inc. · 2015
- 4 generations backK161216 Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis…Immunalysis Corporation · 2017
- 3 generations backK180427 ARK Fentanyl AssayArk Diagnostics, Inc. · 2018
- 2 generations backK220046 Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence…Shenzhen Superbio Technology Co., Ltd. · 2022
- 1 generation backK240124 BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA ReaderVivachek Biotech (Hangzhou) Co., Ltd. · 2024
- This deviceK251972 Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit -…Healgen Scientific,, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001178 | Cedia Dau 6-Acetylmorphine Assay | Microgenics Corp. | 2000 | — |
| −6 | K040316 | Cedia Buprenorphine Assay | Microgenics Corp. | 2004 | — |
| −5 | K150606 | Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug… | Siemens Healthcare Diagnostics, Inc. | 2015 | — |
| −4 | K161216 | Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl… | Immunalysis Corporation | 2017 | — |
| −3 | K180427 | ARK Fentanyl Assay | Ark Diagnostics, Inc. | 2018 | — |
| −2 | K220046 | Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer… | Shenzhen Superbio Technology Co., Ltd. | 2022 | — |
| −1 | K240124 | BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024 | — |
| 0 (this device) | K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit -… | Healgen Scientific,, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 DJG? 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 DJG device
- #1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K240124 | BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA ReaderSummary page 5….2560 Clinical Chemistry Fluorometer for clinical use 5. Predicate Devices: BioSieve™ Fentanyl FIA Test Kit, K240124 BioSieve™ ToxiSmart FIA Reader, K240124 6. Indications for Use Healgen AccuFluor Fentanyl Fluorescence Immunoassay (FIA) T… | 2024 |
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 25 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K240124.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DJG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJG
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJG
1in 2025
MAUDE reports naming product code DJG, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 187 | 0 | 0 |
| 2011 | 6 | 233 | 1 | 4 |
| 2012 | 5 | 95 | 0 | 1 |
| 2013 | 5 | 60 | 0 | 4 |
| 2014 | 9 | 62 | 0 | 0 |
| 2015 | 12 | 141 | 0 | 3 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 4 | 101 | 0 | 1 |
| 2018 | 5 | 134 | 0 | 1 |
| 2019 | 3 | 235 | 1 | 0 |
| 2020 | 5 | 30 | 0 | 0 |
| 2021 | 3 | 422 | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 10 | 140 | 0 | 0 |
| 2024 | 5 | 150 | 0 | 3 |
| 2025 | 3 | 31 | 2 | 1 |
| 2026 | 3 | 157 | 0 | — |
What is it indicated for?
The Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA) Test Kit-Qualitative is a fluorescence immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with Healgen® Immunofluorescence analyzer OG-H180. This in vitro diagnostic device is for prescription use only. This assay provides only a preliminary analytical test result. A more specific alternate…
Read the full statement (153 words)
The Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA) Test Kit-Qualitative is a fluorescence immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with Healgen® Immunofluorescence analyzer OG-H180. This in vitro diagnostic device is for prescription use only.
This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas Chromatography-Mass Spectrometry (GC-MS) and Liquid Chromatography-Mass Spectrometry (LC-MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to a Fentanyl test result, particularly when a preliminary positive result is obtained.
The Healgen® Immunofluorescence analyzer OG-H180 is a portable fluorescence instrument for in vitro diagnostic use only. The analyzer is designed to detect test results from in vitro diagnostic tests on clinical specimens. This analyzer can be used in a laboratory or point-of-care setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251972 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251972: Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251972
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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