510(k) · Cleared
ClearedSEFRIA™ Hydrocodone Oral Fluid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immunalysis Corporation · DJG Enzyme Immunoassay, Opiates
Cleared on Sep 11, 2025 as substantially equivalent to K203564 (Immunalysis Corporation, 2021) after a 31-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Sep 11, 2025
- Review
- 31 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K924446 (1992). No later device cites it as a predicate yet.
- Root · 4 generations backK924446 Micro-Plate Opiates AssaySolarcare Technologies Corp,Inc. · 1992
- 3 generations backK981341 STC Opiates Micro-Plate Eia (Orasure Application)OraSure Technologies, Inc. · 1998
- 2 generations backK101754 Thermo Scientific Cedia Opiate Oft AssayMicrogenics Corp. · 2011
- 1 generation backK203564 SEFRIA Oxycodone Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2021
- This deviceK252520 SEFRIA™ Hydrocodone Oral FluidImmunalysis Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K924446 | Micro-Plate Opiates Assay | Solarcare Technologies Corp,Inc. | 1992 | — |
| −3 | K981341 | STC Opiates Micro-Plate Eia (Orasure Application) | OraSure Technologies, Inc. | 1998 | — |
| −2 | K101754 | Thermo Scientific Cedia Opiate Oft Assay | Microgenics Corp. | 2011 | — |
| −1 | K203564 | SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay | Immunalysis Corporation | 2021 | — |
| 0 (this device) | K252520 | SEFRIA™ Hydrocodone Oral Fluid | Immunalysis Corporation | 2025 | — |
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 |
|---|---|---|---|
| * | K203564 | SEFRIA Oxycodone Oral Fluid Enzyme ImmunoassaySummary page 6…Toxicology (91) 2. Predicate Information Company: Immunalysis Corporation Device: SEFRIA™ Oxycodone Oral Fluid Enzyme Immunoassay (K203564) 3. Device Description The Immunalysis SEFRIA™ Hydrocodone Oral Fluid Enzyme Immunoassay is a homogenous enzyme immunoassay wi… | 2021 |
| † | K223781 | Quantisal™ II Oral Fluid Collection Device | 2023 |
| † | K232898 | Quantisal™ Oral Fluid Collection Device | 2023 |
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 33 years and passes through 4 companies; a new generation was cleared every 10.7 years on median.
- None of the 4 ancestors has a recall.
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 Immunalysis SEFRIA™ Hydrocodone Oral Fluid Enzyme Immunoassay is an enzyme immunoassay with a cutoff of 30 ng/mL in neat oral fluid collected by Quantisal™ or Quantisal™ II Oral Fluid Collection Device. The assay is intended for the qualitative and semi-quantitative analysis of hydrocodone in human oral fluid to be used with clinical analyzers. This assay is calibrated against hydrocodone. The semi-quantitative mode is for purposes of enabling…
Read the full statement (162 words)
The Immunalysis SEFRIA™ Hydrocodone Oral Fluid Enzyme Immunoassay is an enzyme immunoassay with a cutoff of 30 ng/mL in neat oral fluid collected by Quantisal™ or Quantisal™ II Oral Fluid Collection Device. The assay is intended for the qualitative and semi-quantitative analysis of hydrocodone in human oral fluid to be used with clinical analyzers. This assay is calibrated against hydrocodone.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.
The Immunalysis SEFRIA™ Hydrocodone Oral Fluid Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC-MS or LC-MS/MS are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any test result, particularly when preliminary positive results are used.
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/K252520 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252520: SEFRIA™ Hydrocodone Oral Fluid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252520
Report an extraction error
Are you the manufacturer?
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