510(k) · Cleared
ClearedMicro-Plate Opiates Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solarcare Technologies Corp,Inc. · DJG Enzyme Immunoassay, Opiates
Cleared on Oct 15, 1992 after a 44-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 21 later devices descend from it.
- Decided
- Oct 15, 1992
- Review
- 44 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 1 citing it directly.
- This deviceK924446 Micro-Plate Opiates AssaySolarcare Technologies Corp,Inc. · 1992
- Descendant · cites it directly · 20 of its ownK981341 STC Opiates Micro-Plate Eia (Orasure Application)OraSure Technologies, Inc. · 1998
- Descendant · 2 generations on · 6 of its ownK103227 Oratect Oral Fluid Drug Screen DevicesBranan Medical Corporation · 2012
- Descendant · 2 generations on · 6 of its ownK050988 Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and…Lin-Zhi International, Inc. · 2006
- Descendant · 3 generations on · 3 of its ownK171403 OralTox Oral Fluid Drug TestPremier Biotech, Inc. · 2018
- Descendant · 2 generations on · 3 of its ownK101754 Thermo Scientific Cedia Opiate Oft AssayMicrogenics Corp. · 2011
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K981341STC Opiates Micro-Plate Eia (Orasure Application)OraSure Technologies, Inc. · 1998 · cites it directly20descendants
- K103227Oratect Oral Fluid Drug Screen DevicesBranan Medical Corporation · 2012 · 2 generations on6descendants
- K050988Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and ControlsLin-Zhi International, Inc. · 2006 · 2 generations on6descendants
- K171403OralTox Oral Fluid Drug TestPremier Biotech, Inc. · 2018 · 3 generations on3descendants
- K101754Thermo Scientific Cedia Opiate Oft AssayMicrogenics Corp. · 2011 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924446 | Micro-Plate Opiates Assay | Solarcare Technologies Corp,Inc. | 1992 | — |
| +1 | K981341 | STC Opiates Micro-Plate Eia (Orasure Application) | OraSure Technologies, Inc. | 1998 | — |
| +2 | K103227 | Oratect Oral Fluid Drug Screen Devices | Branan Medical Corporation | 2012 | — |
| +2 | K050988 | Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and Controls | Lin-Zhi International, Inc. | 2006 | — |
| +3 | K171403 | OralTox Oral Fluid Drug Test | Premier Biotech, Inc. | 2018 | — |
| +2 | K101754 | Thermo Scientific Cedia Opiate Oft Assay | Microgenics Corp. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2021 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (21)
See all 211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981341 | STC Opiates Micro-Plate Eia (Orasure Application) | 1998 | 20 |
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?
- Of its descendants, K981341 (OraSure Technologies, Inc., 1998) has gone furthest, with 20 descendants of its own.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K924446 · printed Nov 6, 2026
Cite this page
510(k) Report. “K924446: Micro-Plate Opiates Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924446
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026