510(k) · Cleared
ClearedOral Fluid Cocaine Metabolite Homogeneous Enzyme Immunoassays, 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 Mar 29, 2006 as substantially equivalent to K001197 (OraSure Technologies, Inc., 2000) after a 349-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Mar 29, 2006
- Review
- 349 days
- Class
- Class II
- Product code
- DIO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001197 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK001197 Cocaine Metabolite Intercept Micro-Plate EiaOraSure Technologies, Inc. · 2000
- This deviceK050945 Oral Fluid Cocaine Metabolite Homogeneous Enzyme Immunoassays…Lin-Zhi International, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK063024 Lzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay…Lin-Zhi International, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK131653 Lzi Oral Fluid Amphetamine Enzyme Immunoassay, Calibrators, ControlsLin-Zhi International, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See all- K063024Lzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay: Lzi Amphetamine Oral…Lin-Zhi International, Inc. · 2006 · cites it directly1descendant
- K131653Lzi Oral Fluid Amphetamine Enzyme Immunoassay, Calibrators, ControlsLin-Zhi International, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001197 | Cocaine Metabolite Intercept Micro-Plate Eia | OraSure Technologies, Inc. | 2000 | — |
| 0 (this device) | K050945 | Oral Fluid Cocaine Metabolite Homogeneous Enzyme Immunoassays, Calibrators &… | Lin-Zhi International, Inc. | 2006 | — |
| +1 | K063024 | Lzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay: Lzi… | Lin-Zhi International, Inc. | 2006 | — |
| +2 | K131653 | Lzi Oral Fluid Amphetamine Enzyme Immunoassay, Calibrators, Controls | Lin-Zhi International, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2014 | 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 3.1 · 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 |
|---|---|---|---|
| * | K001197 | Cocaine Metabolite Intercept Micro-Plate Eia | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063024 | Lzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay: Lzi Amphetamine Oral… | 2006 | 1 |
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 (Benzoylecgonine) Enzyme Immunoassays for Drugs of Abuse in Oral Fluid is a homogeneous enzyme immunoassay system to detect cocaine metabolite in human saliva with a cutoff of 15 ng/mL when testing oral fluid specimen collected with Salivette collector (manufactured by Sarstedt ) and diluted with 1 mL of buffer. The calibrators and controls of the analyte (Benzoylecgonine) are prepared with oral fluid buffer so that it can be used…
Read the full statement (172 words)
The Cocaine Metabolite (Benzoylecgonine) Enzyme Immunoassays for Drugs of Abuse in Oral Fluid is a homogeneous enzyme immunoassay system to detect cocaine metabolite in human saliva with a cutoff of 15 ng/mL when testing oral fluid specimen collected with Salivette collector (manufactured by Sarstedt ) and diluted with 1 mL of buffer. The calibrators and controls of the analyte (Benzoylecgonine) are prepared with oral fluid buffer so that it can be used to verify and validate the assay. The assay is intended for use in the qualitative determination for cocaine/cocaine metabolite drugs. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Cocaine Metabolite (Benzoylecgonine) Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay system 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 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/K050945 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050945: Oral Fluid Cocaine Metabolite Homogeneous Enzyme Immunoassays, Calibrators & Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050945
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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