510(k) · Cleared
ClearedCocaine Metabolite Enzyme Immunoassay Models #0030 (500 Tests Kit), #0031 (5000 Tests Kit)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lin-Zhi International, Inc. · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cleared on May 10, 2002 as substantially equivalent to K960187 (Diagnostic Reagents, Inc., 1996) after a 64-day review. Its family tree reaches back 1 generation to 1996. 4 later devices descend from it.
- Decided
- May 10, 2002
- Review
- 64 days
- Class
- Class II
- Product code
- DIO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960187 (1996). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK960187 Cocaine Metabolite Eia TestDiagnostic Reagents, Inc. · 1996 · Recalled
- This deviceK020763 Cocaine Metabolite Enzyme Immunoassay Models #0030 (500 Tests Kit)…Lin-Zhi International, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK113139 Lzi Cocaine Metabolite Homogeneous Enzyme…Lin-Zhi International, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK213211 Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme…Carolina Liquid Chemistries Corp. · 2022
- Descendant · 2 generations on · 0 of its ownK191638 Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DX · 2020
- Descendant · cites it directly · 0 of its ownK033866 Camp Multiple Analyte Enzyme Immunoassay, Cat.# 0510, 0511 (500 &…Lin-Zhi International, Inc. · 2004
Most influential descendants
Showing 4 of 4 · See all- K113139Lzi Cocaine Metabolite Homogeneous Enzyme Immunoassay,Calibrators,ControlsLin-Zhi International, Inc. · 2011 · cites it directly1descendant
- K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM)…Carolina Liquid Chemistries Corp. · 2022 · cites it directly0descendants
- K191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DX · 2020 · 2 generations on0descendants
- K033866Camp Multiple Analyte Enzyme Immunoassay, Cat.# 0510, 0511 (500 & 5000 Test Kits)Lin-Zhi International, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960187 | Cocaine Metabolite Eia Test | Diagnostic Reagents, Inc. | 1996 | 1 |
| 0 (this device) | K020763 | Cocaine Metabolite Enzyme Immunoassay Models #0030 (500 Tests Kit), #0031… | Lin-Zhi International, Inc. | 2002 | — |
| +1 | K113139 | Lzi Cocaine Metabolite Homogeneous Enzyme Immunoassay,Calibrators,Controls | Lin-Zhi International, Inc. | 2011 | — |
| +1 | K213211 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay… | Carolina Liquid Chemistries Corp. | 2022 | — |
| +2 | K191638 | Pointe Scientific Cocaine Metabolite Enzyme Immunoassay | Medtest DX | 2020 | — |
| +1 | K033866 | Camp Multiple Analyte Enzyme Immunoassay, Cat.# 0510, 0511 (500 & 5000 Test… | Lin-Zhi International, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2011 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 DIO? 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 DIO device
- #1 K213211 Carolina Liquid Chemistries Cocaine and…score 3.0 · 2 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 |
|---|---|---|---|
| * | K960187 | Cocaine Metabolite Eia TestSummary page 1…e Metabolite Enzyme Immunoassay is substantially equivalent to the Cocaine Metabolite Enzyme Immunoassay (By DRI/Microgenics Corp.), cleared under premarket notification K960187. LZI’s Cocaine Metabolite Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method principle… | 1996 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113139 | Lzi Cocaine Metabolite Homogeneous Enzyme Immunoassay,Calibrators,Controls | 2011 | 1 |
| K213211 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM)… | 2022 | 0 |
| K033866 | Camp Multiple Analyte Enzyme Immunoassay, Cat.# 0510, 0511 (500 & 5000 Test Kits) | 2004 | 0 |
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?
How does its category compare?
All DIO devicesDIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · DIO
267in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIO
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIO
1in 2023
MAUDE reports naming product code DIO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 5 | 65 | 0 | 4 |
| 2012 | 5 | 139 | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 3 | 88 | 0 | 9 |
| 2017 | 3 | 267 | 0 | 16 |
| 2018 | 1 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 22 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Cocaine Metabolite Enzyme Immunoassay is a homogeneous enzyme immunoassay
with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semi-
quantitative analyses of benzoylecgonine (cocaine metabolite) in human urine.
The Cocaine Metabolite Enzyme Immunoassay provides only a preliminary analytical test
result. A more specific alternative chemical method must be used to obtain a confirmed
analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred
confirmatory method. Clinical consideration and professional judgement should be applied
to any drug-of-abuse 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/K020763 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020763: Cocaine Metabolite Enzyme Immunoassay Models #0030 (500 Tests Kit), #0031 (5000 Tests Kit).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020763
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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