510(k) · Cleared
ClearedThermo Scientific Cedia Opiate Oft Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corp. · DJG Enzyme Immunoassay, Opiates
Cleared on Apr 8, 2011 as substantially equivalent to K981341 (OraSure Technologies, Inc., 1998) after a 290-day review. Its family tree reaches back 2 generations to 1992. 3 later devices descend from it.
- Decided
- Apr 8, 2011
- Review
- 290 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K924446 (1992). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK924446 Micro-Plate Opiates AssaySolarcare Technologies Corp,Inc. · 1992
- 1 generation backK981341 STC Opiates Micro-Plate Eia (Orasure Application)OraSure Technologies, Inc. · 1998
- This deviceK101754 Thermo Scientific Cedia Opiate Oft AssayMicrogenics Corp. · 2011
- Descendant · cites it directly · 1 of its ownK203564 SEFRIA Oxycodone Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2021
- Descendant · 2 generations on · 0 of its ownK252520 SEFRIA™ Hydrocodone Oral FluidImmunalysis Corporation · 2025
- Descendant · cites it directly · 0 of its ownK133642 Rapidfret Oral Fluid Assay for Opiates; Rapidfret Oral Fluid…Biophor Diagnostics, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See all- K203564SEFRIA Oxycodone Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2021 · cites it directly1descendant
- K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis Corporation · 2025 · 2 generations on0descendants
- K133642Rapidfret Oral Fluid Assay for Opiates; Rapidfret Oral Fluid Calibrators, Controls…Biophor Diagnostics, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K924446 | Micro-Plate Opiates Assay | Solarcare Technologies Corp,Inc. | 1992 | — |
| −1 | K981341 | STC Opiates Micro-Plate Eia (Orasure Application) | OraSure Technologies, Inc. | 1998 | — |
| 0 (this device) | K101754 | Thermo Scientific Cedia Opiate Oft Assay | Microgenics Corp. | 2011 | — |
| +1 | K203564 | SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay | Immunalysis Corporation | 2021 | — |
| +2 | K252520 | SEFRIA™ Hydrocodone Oral Fluid | Immunalysis Corporation | 2025 | — |
| +1 | K133642 | Rapidfret Oral Fluid Assay for Opiates; Rapidfret Oral Fluid Calibrators… | Biophor Diagnostics, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K981341 | STC Opiates Micro-Plate Eia (Orasure Application)Summary page 2…keted device to which equivalency is claimed CEDIA® Opiate OFT Assay is substantially equivalent to the previously cleared STC Opiates MICRO-PLATE EIA, K981 341 (At present OTI, OraSure Technologies Inc.) DESCRIPTION OF DEVICE Principle of the CEDIA® Opiate OFT Assay Microgenics; CEDIA® O… | 1998 |
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 19 years and passes through 3 companies; a new generation was cleared every 12.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K203564 (Immunalysis Corporation, 2021) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K981341.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 CEDIA® Opiate OFT Assay is intended for use in the qualitative determination of opiate in human oral fluid at a cutoff concentration of 30 nglmL in neat oral fluid. The specimen must be collected exclusively with the Oral-EzeTM Saliva Collection System. The assay is calibrated against morphine and performed on the MG0240. This in vitro diagnostic device is intended for clinical laboratory use only. The CEDIA Opiate OFT Assay provides only a…
Read the full statement (128 words)
The CEDIA® Opiate OFT Assay is intended for use in the qualitative determination of opiate in human oral fluid at a cutoff concentration of 30 nglmL in neat oral fluid. The specimen must be collected exclusively with the Oral-EzeTM Saliva Collection System. The assay is calibrated against morphine and performed on the MG0240. This in vitro diagnostic device is intended for clinical laboratory use only.
The CEDIA Opiate OFT Assay provides only a preliminary analytical test result. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography-Tandem Mass Spectrometry (LG-MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result particularly when preliminary positive results are used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101754 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101754: Thermo Scientific Cedia Opiate Oft Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101754
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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