510(k) · Cleared
ClearedAmphetamines Enzyme Immunoassay, Catalog #0040 (500 Tests Kit), Catalog #0041 (5000 Tests Kit)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lin-Zhi International, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Jun 4, 2002 as substantially equivalent to K934891 (Diagnostic Reagents, Inc., 1994) after a 118-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it.
- Decided
- Jun 4, 2002
- Review
- 118 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934891 (1994). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK934891 Amphetamines Eia Assay ModificationDiagnostic Reagents, Inc. · 1994
- This deviceK020395 Amphetamines Enzyme Immunoassay, Catalog #0040 (500 Tests Kit)…Lin-Zhi International, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK102210 Lzi Amphetamines 500 Homogenous Enzyme Immunoassay; Lzi Amphetamines…Lin-Zhi International, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK113661 Lzi Methamphetamine Enzyme Mmunoassay, Lzi Methamphetamine…Lin-Zhi International, Inc. · 2012
- Descendant · 3 generations on · 0 of its ownK201442 Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay…Diatron Group · 2020
Most influential descendants
Showing 3 of 3 · See all- K102210Lzi Amphetamines 500 Homogenous Enzyme Immunoassay; Lzi Amphetamines 500 Calibrators…Lin-Zhi International, Inc. · 2010 · cites it directly2descendants
- K113661Lzi Methamphetamine Enzyme Mmunoassay, Lzi Methamphetamine Calibrators, Lzi…Lin-Zhi International, Inc. · 2012 · 2 generations on1descendant
- K201442Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus AnalyzersDiatron Group · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934891 | Amphetamines Eia Assay Modification | Diagnostic Reagents, Inc. | 1994 | — |
| 0 (this device) | K020395 | Amphetamines Enzyme Immunoassay, Catalog #0040 (500 Tests Kit), Catalog #0041… | Lin-Zhi International, Inc. | 2002 | — |
| +1 | K102210 | Lzi Amphetamines 500 Homogenous Enzyme Immunoassay; Lzi Amphetamines 500… | Lin-Zhi International, Inc. | 2010 | — |
| +2 | K113661 | Lzi Methamphetamine Enzyme Mmunoassay, Lzi Methamphetamine Calibrators, Lzi… | Lin-Zhi International, Inc. | 2012 | — |
| +3 | K201442 | Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for… | Diatron Group | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 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 DKZ? 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 DKZ device
- #1 K233019 AllTest Multi-Drug Rapid Test Cup; AllTest…score 14.6 · 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? (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 |
|---|---|---|---|
| * | K934891 | Amphetamines Eia Assay ModificationSummary page 1…s. ’I equivafent to the Amphetamines Enzyme Immunoassay by Diagnostic Reagents kc. (now Mcrogenics, kc.), cleared under pemarket notification K934891. LZI’s Amphetamines Enzyme Immunoassay is identical or similar to its predicate in terns of intended use, method principle, devi… | 1994 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102210 | Lzi Amphetamines 500 Homogenous Enzyme Immunoassay; Lzi Amphetamines 500 Calibrators… | 2010 | 2 |
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?
- Its one ancestor has no recall.
- Of its descendants, K102210 (Lin-Zhi International, Inc., 2010) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DKZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DKZ
180in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DKZ
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKZ
2in 2025
MAUDE reports naming product code DKZ, 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 | — | 1 | 0 |
| 2008 | 2 | — | 3 | 12 |
| 2009 | 2 | — | 5 | 1 |
| 2010 | 4 | 233 | 0 | 1 |
| 2011 | 6 | 123 | 4 | 2 |
| 2012 | 5 | 55 | 0 | 0 |
| 2013 | 8 | 103 | 1 | 1 |
| 2014 | 8 | 128 | 3 | 9 |
| 2015 | 5 | 107 | 0 | 8 |
| 2016 | 5 | 215 | 0 | 8 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 3 | 128 | 0 | 0 |
| 2019 | 3 | 180 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 7 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Amphetamines Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 1000 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of amphetamines in human urine.
The Amphetamines 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 as stated in the FDA summary.
https://510kreport.com/device/K020395 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020395: Amphetamines Enzyme Immunoassay, Catalog #0040 (500 Tests Kit), Catalog #0041 (5000 Tests Kit).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020395
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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