510(k) · Cleared
ClearedLzi Methamphetamine Enzyme Mmunoassay, Lzi Methamphetamine Calibrators, Lzi Methamphetamine Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lin-Zhi International, Inc. · LAF Gas Chromatography, Methamphetamine
Cleared on Jan 23, 2012 as substantially equivalent to K102210 (Lin-Zhi International, Inc., 2010) after a 41-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- Jan 23, 2012
- Review
- 41 days
- Class
- Class II
- Product code
- LAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K934891 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK934891 Amphetamines Eia Assay ModificationDiagnostic Reagents, Inc. · 1994
- 2 generations backK020395 Amphetamines Enzyme Immunoassay, Catalog #0040 (500 Tests Kit)…Lin-Zhi International, Inc. · 2002
- 1 generation backK102210 Lzi Amphetamines 500 Homogenous Enzyme Immunoassay; Lzi Amphetamines…Lin-Zhi International, Inc. · 2010
- This deviceK113661 Lzi Methamphetamine Enzyme Mmunoassay, Lzi Methamphetamine…Lin-Zhi International, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK201442 Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay…Diatron Group · 2020
Most influential descendants
Showing 1 of 1 · See all- K201442Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus AnalyzersDiatron Group · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K934891 | Amphetamines Eia Assay Modification | Diagnostic Reagents, Inc. | 1994 | — |
| −2 | 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 | — |
| 0 (this device) | K113661 | Lzi Methamphetamine Enzyme Mmunoassay, Lzi Methamphetamine Calibrators, Lzi… | Lin-Zhi International, Inc. | 2012 | — |
| +1 | 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 |
|---|---|---|
| 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 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
- #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 |
|---|---|---|---|
| * | K102210 | Lzi Amphetamines 500 Homogenous Enzyme Immunoassay; Lzi Amphetamines 500 Calibrators…Summary page 4…the Lin-Zhi International, Inc. Amphetamines 500 Enzyme Immunoassay, Calibrators and Controls for Hitachi 717 Systems cleared by the FDA under the premarket notification k102210 for its stated intended use. The following table compares 1LZI's Methamphetamine Enzyme Immunoassay at the 500 ng/mL cutoff with… | 2010 |
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 |
|---|---|---|---|
| K201442 | Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers | 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 18 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K201442 (Diatron Group, 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LAF devicesLAF Gas Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 LZI Methamphetamine Enzyme Immunoassay is intended for the qualitative and semniquantitative determination of d-methamphetamine in human urine, at the cutoff value of 500 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 (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as…
Read the full statement (203 words)
The LZI Methamphetamine Enzyme Immunoassay is intended for the qualitative and semniquantitative determination of d-methamphetamine in human urine, at the cutoff value of 500 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 (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS and LCMS or (2) permitting laboratories to establish quality control procedures.
The LZI Methamphetamine Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Methamphetamine Enzyme Immunoassay at a cutoff value of 500 ng/nt.
The LZI Methamphetamine Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the Methamphetamine Enzyme Immunoassay at a cutoff value of 500 ng/nmh.
The assay provides only a preliminary analytical result. A more specific alternatfive 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K113661 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113661: Lzi Methamphetamine Enzyme Mmunoassay, Lzi Methamphetamine Calibrators, Lzi Methamphetamine Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113661
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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