510(k) · Cleared
ClearedDoa Liquid Drugs of Abuse Controls Levls 2,3,& 4,G2,G3,& G4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Analysis Systems, Inc. · DIF Drug Mixture Control Materials
Cleared on Jul 20, 1994 after a 170-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Jul 20, 1994
- Review
- 170 days
- Class
- Class I
- Product code
- DIF
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK940433 Doa Liquid Drugs of Abuse Controls Levls 2,3,& 4,G2,G3,& G4Medical Analysis Systems, Inc. · 1994
- Descendant · cites it directly · 8 of its ownK983807 Lyphochek Tumor Marker Control, Model #580Bio-Rad · 1998
- Descendant · 2 generations on · 7 of its ownK992172 Lyphochek Tumor Marker Control, Model 580Bio-Rad · 1999
- Descendant · 3 generations on · 6 of its ownK011579 Lyphochek Tumor Marker Control, Levels 1 and 2, 2ML, Model 580Bio-Rad · 2001
- Descendant · 4 generations on · 2 of its ownK071675 Liquichek Tumor Marker ControlBio-Rad Laboratories · 2007
- Descendant · 4 generations on · 1 of its ownK082036 Lyphochek Tumor Market Plus Control Level 1, 2 and 3 and MinipakBio-Rad Laboratories · 2008
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K983807Lyphochek Tumor Marker Control, Model #580Bio-Rad · 1998 · cites it directly8descendants
- K992172Lyphochek Tumor Marker Control, Model 580Bio-Rad · 1999 · 2 generations on7descendants
- K011579Lyphochek Tumor Marker Control, Levels 1 and 2, 2ML, Model 580Bio-Rad · 2001 · 3 generations on6descendants
- K071675Liquichek Tumor Marker ControlBio-Rad Laboratories · 2007 · 4 generations on2descendants
- K082036Lyphochek Tumor Market Plus Control Level 1, 2 and 3 and MinipakBio-Rad Laboratories · 2008 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940433 | Doa Liquid Drugs of Abuse Controls Levls 2,3,& 4,G2,G3,& G4 | Medical Analysis Systems, Inc. | 1994 | — |
| +1 | K983807 | Lyphochek Tumor Marker Control, Model #580 | Bio-Rad | 1998 | — |
| +2 | K992172 | Lyphochek Tumor Marker Control, Model 580 | Bio-Rad | 1999 | — |
| +3 | K011579 | Lyphochek Tumor Marker Control, Levels 1 and 2, 2ML, Model 580 | Bio-Rad | 2001 | — |
| +4 | K071675 | Liquichek Tumor Marker Control | Bio-Rad Laboratories | 2007 | — |
| +4 | K082036 | Lyphochek Tumor Market Plus Control Level 1, 2 and 3 and Minipak | Bio-Rad Laboratories | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 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 DIF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983807 | Lyphochek Tumor Marker Control, Model #580 | 1998 | 8 |
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, K983807 (Bio-Rad, 1998) has gone furthest, with 8 descendants of its own.
How does its category compare?
All DIF devicesDIF Drug Mixture Control Materials: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIF
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DIF
35in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIF
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIF
1in 2016
MAUDE reports naming product code DIF, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 3 | 35 | 0 | 3 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 5 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K940433 · printed Nov 4, 2026
Cite this page
510(k) Report. “K940433: Doa Liquid Drugs of Abuse Controls Levls 2,3,& 4,G2,G3,& G4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K940433
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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