510(k) · Cleared
ClearedMethamphetamine Oral Fluid Homogeneous Enzyme Immunoassay; Calibrators and 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 Sep 29, 2006 as substantially equivalent to K993208 (OraSure Technologies, Inc., 2000) and 2 other predicates after a 58-day review. Its family tree reaches back 3 generations to 1992. 3 later devices descend from it.
- Decided
- Sep 29, 2006
- Review
- 58 days
- Class
- Class II
- Product code
- LAF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K924446 (1992). 7 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK924446 Micro-Plate Opiates AssaySolarcare Technologies Corp,Inc. · 1992
- 2 generations backK981341 STC Opiates Micro-Plate Eia (Orasure Application)OraSure Technologies, Inc. · 1998
- 1 generation backK050988 Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and…Lin-Zhi International, Inc. · 2006
- This deviceK062242 Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay…Lin-Zhi International, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK131652 Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators…Lin-Zhi International, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK203647 SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2021
- Descendant · 2 generations on · 0 of its ownK142293 Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid…Biophor Diagnostics, Inc. · 2015
Most influential descendants
Showing 3 of 3 · See all- K131652Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, ControlsLin-Zhi International, Inc. · 2014 · cites it directly2descendants
- K203647SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2021 · 2 generations on0descendants
- K142293Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine…Biophor Diagnostics, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K924446 | Micro-Plate Opiates Assay | Solarcare Technologies Corp,Inc. | 1992 | — |
| −2 | K981341 | STC Opiates Micro-Plate Eia (Orasure Application) | OraSure Technologies, Inc. | 1998 | — |
| −1 | K050988 | Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and Controls | Lin-Zhi International, Inc. | 2006 | — |
| 0 (this device) | K062242 | Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay; Calibrators and… | Lin-Zhi International, Inc. | 2006 | — |
| +1 | K131652 | Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, Controls | Lin-Zhi International, Inc. | 2014 | — |
| +2 | K203647 | SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay | Immunalysis Corporation | 2021 | — |
| +2 | K142293 | Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid… | Biophor Diagnostics, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2021 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K993208 | STC Methamphetamine Intercept Micro-Plate Eia, Model 1104ISummary page 2…egally Marketed Predicate Device(s) The LZI Oral Fluid Methamphetamine Enzyme Immunoassay is substantially equivalent to the Methamphetamine Intercept® Micro-plate EIA (K993208) manufactured by OraSure Technologies Inc. (formerly known as STC Technologies, Inc) for its general intended use. The current su… | 2000 |
| Kept off the family tree | K050904 | FDA’s K050904 is Cpap Humidifier, Model HC238JHU Our reading of the summary gave K050904, FDA’s number for Cpap Humidifier, Model HC238JHU (Fisher & Paykel Healthcare, Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Oral Fluid Cocaine Homogeneous Enzyme Immunoassay”. Kept off the family tree. Summary page 2…s, Inc) for its general intended use. The current subject device is also substantially equivalent to other LZI test systems cleared by FDA, e.g., the Oral Fluid Cocaine (K0509045), Opiate (K050988), and Methadone (K051058) Homogeneous Enzyme Immunoassay for its stated intended use. Device Description LZI… | 2005 |
| * | K050988 | Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and ControlsSummary page 2…eral intended use. The current subject device is also substantially equivalent to other LZI test systems cleared by FDA, e.g., the Oral Fluid Cocaine (K0509045), Opiate (K050988), and Methadone (K051058) Homogeneous Enzyme Immunoassay for its stated intended use. Device Description LZI's Oral Fluid Metha… | 2006 |
| * | K051058 | Methadone Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and ControlsSummary page 2…rrent subject device is also substantially equivalent to other LZI test systems cleared by FDA, e.g., the Oral Fluid Cocaine (K0509045), Opiate (K050988), and Methadone (K051058) Homogeneous Enzyme Immunoassay for its stated intended use. Device Description LZI's Oral Fluid Methamphetamine Enzyme Immunoa… | 2006 |
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 |
|---|---|---|---|
| K131652 | Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, Controls | 2014 | 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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K131652 (Lin-Zhi International, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K993208.
How does its category compare?
All LAF devicesLAF Gas Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Methamphetamine Enzyme Immunoassays for Drugs of Abuse in Oral Fluid is a homogeneous enzyme immunoassay system to detect methamphetamine in human saliva with a cutoff of 45 ng/mL when testing oral fluid specimen collected with Salivette collector (manufactured by Sarstedt) and diluted with I mL of buffer. The calibtators and controls of the analyte (d-methamphetamine) are prepared with oral fluid buffer so that it can be used to verify and validate…
Read the full statement (164 words)
The Methamphetamine Enzyme Immunoassays for Drugs of Abuse in Oral Fluid is a homogeneous enzyme immunoassay system to detect methamphetamine in human saliva with a cutoff of 45 ng/mL when testing oral fluid specimen collected with Salivette collector (manufactured by Sarstedt) and diluted with I mL of buffer. The calibtators and controls of the analyte (d-methamphetamine) 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 methamphetamine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Oral Fluid Methamphetamine 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/K062242 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062242: Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay; Calibrators and Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062242
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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