510(k) · Cleared
ClearedLzi Cocaine Metabolite Homogeneous Enzyme Immunoassay,Calibrators,Controls
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 Nov 22, 2011 as substantially equivalent to K020763 (Lin-Zhi International, Inc., 2002) and 1 other predicate after a 29-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it.
- Decided
- Nov 22, 2011
- Review
- 29 days
- Class
- Class II
- Product code
- DIO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K983159 (1998). 4 ancestors in all, the oldest K960187 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK983159 Drugs of Abuse Urine Calibrators and ControlsDiagnostic Reagents, Inc. · 1998
- 1 generation backK020769 Single Analyte Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc. · 2002
- This deviceK113139 Lzi Cocaine Metabolite Homogeneous Enzyme…Lin-Zhi International, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK191638 Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DX · 2020
Most influential descendants
Showing 1 of 1 · See all- K191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DX · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983159 | Drugs of Abuse Urine Calibrators and Controls | Diagnostic Reagents, Inc. | 1998 | — |
| −1 | K020769 | Single Analyte Urine Drugs of Abuse Calibrators and Controls | Lin-Zhi International, Inc. | 2002 | — |
| 0 (this device) | K113139 | Lzi Cocaine Metabolite Homogeneous Enzyme Immunoassay,Calibrators,Controls | Lin-Zhi International, Inc. | 2011 | — |
| +1 | K191638 | Pointe Scientific Cocaine Metabolite Enzyme Immunoassay | Medtest DX | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (2)
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 |
|---|---|---|---|
| * | K020763 | Cocaine Metabolite Enzyme Immunoassay Models #0030 (500 Tests Kit), #0031 (5000 Tests Kit)Summary page 2…d Predicate Device(s) The Cocaine Metabolite Enzyme Immunoiassay (EtA) at a cutoff of 150 ng/mL is substantially equivalent to the Cocaine Metabolite Enzyme Immunoassay (k020763), Calibrators and Controls for Hitachi 717 Systems (k020769) manufactured by Lin-Zhi International, Inc with a cutoff of 300 ng/m… | 2002 |
| * | K020769 | Single Analyte Urine Drugs of Abuse Calibrators and ControlsSummary page 2…ssay (EtA) at a cutoff of 150 ng/mL is substantially equivalent to the Cocaine Metabolite Enzyme Immunoassay (k020763), Calibrators and Controls for Hitachi 717 Systems (k020769) manufactured by Lin-Zhi International, Inc with a cutoff of 300 ng/mL. The Cocaine Metabolite Enzyme Immunoassay is… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191638 | Pointe Scientific Cocaine Metabolite Enzyme Immunoassay | 2020 | 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?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 9.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K191638 (Medtest DX, 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K020763.
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. 2011, this device’s year, is highlighted.
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 intended for the qualitative and semniquantitative determination of benzoylecgonine in human urine, at the cutoff value of 150 ng/mL. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The semi-quantitative mode is for purposes of (l) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS…
Read the full statement (199 words)
The Cocaine Metabolite Enzyme Immunoassay is intended for the qualitative and semniquantitative determination of benzoylecgonine in human urine, at the cutoff value of 150 ng/mL. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The semi-quantitative mode is for purposes of (l) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS or (2) permitting laboratories to establish quality control procedures.
The Cocaine Metabolite Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi -quantitative calibration of the Cocaine Metabolite Enzyme Immunoassay at a cutoff value of 150 ng/mL.
The Cocaine Metabolite Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the Cocaine Metabolite Enzyme Immunoassay at a cutoff value of 150 ng/mL.
The assay provides only a preliminary analyticalresult.A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC'/MS or LCAIS) is the preferred confirmatory method). Clinical consideration and professionaljudgment should be exercised with any drug of abuse test result, particularly when the preliminary test result ispositive
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113139: Lzi Cocaine Metabolite Homogeneous Enzyme Immunoassay,Calibrators,Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113139
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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