510(k) · Cleared
ClearedLzi Amphetamines 500 Homogenous Enzyme Immunoassay; Lzi Amphetamines 500 Calibrators; Lzi Amphetamines 500 Controls
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 Dec 28, 2010 as substantially equivalent to K020395 (Lin-Zhi International, Inc., 2002) after a 145-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.
- Decided
- Dec 28, 2010
- Review
- 145 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K934891 (1994). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK934891 Amphetamines Eia Assay ModificationDiagnostic Reagents, Inc. · 1994
- 1 generation backK020395 Amphetamines Enzyme Immunoassay, Catalog #0040 (500 Tests Kit)…Lin-Zhi International, Inc. · 2002
- This deviceK102210 Lzi Amphetamines 500 Homogenous Enzyme Immunoassay; Lzi Amphetamines…Lin-Zhi International, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK113661 Lzi Methamphetamine Enzyme Mmunoassay, Lzi Methamphetamine…Lin-Zhi International, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK201442 Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay…Diatron Group · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K934891 | Amphetamines Eia Assay Modification | Diagnostic Reagents, Inc. | 1994 | — |
| −1 | K020395 | Amphetamines Enzyme Immunoassay, Catalog #0040 (500 Tests Kit), Catalog #0041… | Lin-Zhi International, Inc. | 2002 | — |
| 0 (this device) | K102210 | Lzi Amphetamines 500 Homogenous Enzyme Immunoassay; Lzi Amphetamines 500… | Lin-Zhi International, Inc. | 2010 | — |
| +1 | K113661 | Lzi Methamphetamine Enzyme Mmunoassay, Lzi Methamphetamine Calibrators, Lzi… | Lin-Zhi International, Inc. | 2012 | — |
| +2 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K020395 | Amphetamines Enzyme Immunoassay, Catalog #0040 (500 Tests Kit), Catalog #0041 (5000…Summary page 2…e Immunoassay (EJA) is substantially equivalent to the Lin-Zhi International, Inc. Amphetamines Enzyme Immunoassay, Calibrators and Controls for Hitachi 717 Systems (k020395) manufactured by Lin-Zhi International, Inc. The LZI Amphetamines 500 Enzyme Immunoassay is identical or similar to its predica… | 2002 |
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 |
|---|---|---|---|
| K113661 | Lzi Methamphetamine Enzyme Mmunoassay, Lzi Methamphetamine Calibrators, Lzi… | 2012 | 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?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 8.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K113661 (Lin-Zhi International, Inc., 2012) has gone furthest, with 1 descendant 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. 2010, this device’s year, is highlighted.
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 LZI Amphetamines 500 Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of amphetamine and methamphetarnine in human urine, at a cutoff value of 500 ng/mL when calibrated with d-methamnphetamine. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The LZI Amphetamines 500 Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and…
Read the full statement (162 words)
The LZI Amphetamines 500 Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of amphetamine and methamphetarnine in human urine, at a cutoff value of 500 ng/mL when calibrated with d-methamnphetamine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The LZI Amphetamines 500 Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Amphetamines Enzyme Immunoassay.
The LZI Amphetamines 500 Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the LZI Amphetamines 500 Enzyme Immunoassay.
The assay provides only a preliminary analytical result. 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 LC/MS) is the preferred confirmatory method). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102210 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102210: Lzi Amphetamines 500 Homogenous Enzyme Immunoassay; Lzi Amphetamines 500 Calibrators; Lzi Amphetamines 500 Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102210
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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