510(k) · Cleared
ClearedMethadone 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. · DJR Enzyme Immunoassay, Methadone
Cleared on Mar 29, 2006 as substantially equivalent to K002010 (OraSure Technologies, Inc., 2000) after a 337-day review. Its family tree reaches back 1 generation to 2000. 6 later devices descend from it.
- Decided
- Mar 29, 2006
- Review
- 337 days
- Class
- Class II
- Product code
- DJR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002010 (2000). 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK002010 STC Methadone Intercept Micro-Plate Eia, Model 11421OraSure Technologies, Inc. · 2000
- This deviceK051058 Methadone Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and…Lin-Zhi International, Inc. · 2006
- Descendant · cites it directly · 3 of its ownK062242 Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay…Lin-Zhi International, Inc. · 2006
- Descendant · 2 generations on · 2 of its ownK131652 Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators…Lin-Zhi International, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK063024 Lzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay…Lin-Zhi International, Inc. · 2006
- Descendant · 3 generations on · 0 of its ownK203647 SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2021
- Descendant · 3 generations on · 0 of its ownK142293 Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid…Biophor Diagnostics, Inc. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K062242Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay; Calibrators and ControlsLin-Zhi International, Inc. · 2006 · cites it directly3descendants
- K131652Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, ControlsLin-Zhi International, Inc. · 2014 · 2 generations on2descendants
- K063024Lzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay: Lzi Amphetamine Oral…Lin-Zhi International, Inc. · 2006 · cites it directly1descendant
- K203647SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2021 · 3 generations on0descendants
- K142293Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine…Biophor Diagnostics, Inc. · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002010 | STC Methadone Intercept Micro-Plate Eia, Model 11421 | OraSure Technologies, Inc. | 2000 | — |
| 0 (this device) | K051058 | Methadone Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and Controls | Lin-Zhi International, Inc. | 2006 | — |
| +1 | K062242 | Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay; Calibrators and… | Lin-Zhi International, Inc. | 2006 | — |
| +2 | K131652 | Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, Controls | Lin-Zhi International, Inc. | 2014 | — |
| +1 | K063024 | Lzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay: Lzi… | Lin-Zhi International, Inc. | 2006 | — |
| +3 | K203647 | SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay | Immunalysis Corporation | 2021 | — |
| +3 | K142293 | Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid… | Biophor Diagnostics, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2014 | 2 | 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 DJR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K002010 | STC Methadone Intercept Micro-Plate Eia, Model 11421Summary page 2…None Predicate Device(s) The LZI Methadone Oral Fluid Enzyme Immunoassay is substantially equivalent to the Methadones Intercept® Micro-plate EIA (K0020 10) manufactured by OraSure Technologies Inc. (formerly known as STC Technologies, Inc) for its general intended use. Device Descri… | 2000 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K062242 (Lin-Zhi International, Inc., 2006) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DJR devicesDJR Enzyme Immunoassay, Methadone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DJR
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · DJR
59in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJR
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJR
1in 2025
MAUDE reports naming product code DJR, 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 | — | 0 | 0 |
| 2008 | 0 | — | 2 | 0 |
| 2009 | 1 | — | 1 | 0 |
| 2010 | 3 | 469 | 1 | 3 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 3 | 59 | 0 | 2 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Methadone Enzyme Immunoassays for Drugs of Abuse in Oral Fluid is a homogeneous enzyme immunoassay system to detect methadone in human saliva with a cutoff of 30 ng/mL when testing oral fluid specimen collected with Salivette collector (manufactured by Sarstedt and diluted with I mL of buffer. The calibrators and controls of the analyte (Methadone) are prepared with oral fluid buffer so that it can be used to verify and validate the assay. The assay…
Read the full statement (155 words)
The Methadone Enzyme Immunoassays for Drugs of Abuse in Oral Fluid is a homogeneous enzyme immunoassay system to detect methadone in human saliva with a cutoff of 30 ng/mL when testing oral fluid specimen collected with Salivette collector (manufactured by Sarstedt and diluted with I mL of buffer. The calibrators and controls of the analyte (Methadone) 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 Methadone drugs. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Methadone Oral FluidEnzyme Immunoassay is a homogeneous enzyme immunoassay system provides only a preliminary analyticaltest result. A more specific alternativechemical method must be used to obtain a confirmed analyticalresult. Gas chromatography/mass spectrometry (GCIMS) is the preferredconfirmatory method. Clinical considerationandprofessionaljudgment should be applied to any drug-of-abuse test result, particularlywhen preliminarypositive results are used
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051058 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051058: Methadone 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 5, 2026. https://510kreport.com/device/K051058
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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