510(k) · Cleared
ClearedLin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diatron Group · LAF Gas Chromatography, Methamphetamine
Cleared on Jul 31, 2020 as substantially equivalent to K113661 (Lin-Zhi International, Inc., 2012) after a 60-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Jul 31, 2020
- Review
- 60 days
- Class
- Class II
- Product code
- LAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K934891 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backK934891 Amphetamines Eia Assay ModificationDiagnostic Reagents, Inc. · 1994
- 3 generations backK020395 Amphetamines Enzyme Immunoassay, Catalog #0040 (500 Tests Kit)…Lin-Zhi International, Inc. · 2002
- 2 generations backK102210 Lzi Amphetamines 500 Homogenous Enzyme Immunoassay; Lzi Amphetamines…Lin-Zhi International, Inc. · 2010
- 1 generation backK113661 Lzi Methamphetamine Enzyme Mmunoassay, Lzi Methamphetamine…Lin-Zhi International, Inc. · 2012
- This deviceK201442 Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay…Diatron Group · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K934891 | Amphetamines Eia Assay Modification | Diagnostic Reagents, Inc. | 1994 | — |
| −3 | K020395 | Amphetamines Enzyme Immunoassay, Catalog #0040 (500 Tests Kit), Catalog #0041… | Lin-Zhi International, Inc. | 2002 | — |
| −2 | 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 | — |
| 0 (this device) | K201442 | Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for… | Diatron Group | 2020 | — |
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 LAF? 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 LAF device
- #1 K203647 SEFRIA Methamphetamine Oral Fluid Enzyme…score 3.8 · 5 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K113661 | Lzi Methamphetamine Enzyme Mmunoassay, Lzi Methamphetamine Calibrators, Lzi…Summary page 4…Panel: Toxicology 91 807.92 (a)(3): Identification of the legally marketed predicate devices LZI Methamphetamine Immunoassay reagent cleared under K113661 807.92 (a)(4): Device Description Methamphetamine Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for P… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 3 companies; a new generation was cleared every 8.5 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All LAF devicesLAF Gas Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LAF
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LAF
43in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LAF
No recall names LAF since 2007.
Adverse event reports per year · LAF
No MAUDE report names LAF since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 345 | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 43 | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers is intended for the qualitative determination of d-methamphetamine in human urine at a cutoff value of 500 ng/mL. The system was calibrated with d-methamphetamine. The assay provides a rapid screening procedure for determining the presence of d-methamphetamine in urine. The assay provides only a preliminary analytical result. A more specific alternative…
Read the full statement (112 words)
The Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers is intended for the qualitative determination of d-methamphetamine in human urine at a cutoff value of 500 ng/mL. The system was calibrated with d-methamphetamine. The assay provides a rapid screening procedure for determining the presence of d-methamphetamine in urine.
The assay provides only a preliminary analytical result. A more specific alternative analytical chemistry method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS) are the preferred confirmatory methods. 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/K201442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201442: Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201442
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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