510(k) · Cleared
ClearedOpiate 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. · DLG Coating, Liquid, Glc
Cleared on Apr 6, 2006 as substantially equivalent to K981341 (OraSure Technologies, Inc., 1998) after a 352-day review. Its family tree reaches back 2 generations to 1992. 6 later devices descend from it.
- Decided
- Apr 6, 2006
- Review
- 352 days
- Class
- Class I
- Product code
- DLG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K924446 (1992). 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK924446 Micro-Plate Opiates AssaySolarcare Technologies Corp,Inc. · 1992
- 1 generation backK981341 STC Opiates Micro-Plate Eia (Orasure Application)OraSure Technologies, Inc. · 1998
- This deviceK050988 Opiate 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 |
|---|---|---|---|---|---|
| −2 | K924446 | Micro-Plate Opiates Assay | Solarcare Technologies Corp,Inc. | 1992 | — |
| −1 | K981341 | STC Opiates Micro-Plate Eia (Orasure Application) | OraSure Technologies, Inc. | 1998 | — |
| 0 (this device) | K050988 | Opiate 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 DLG? 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 |
|---|---|---|---|
| * | K981341 | STC Opiates Micro-Plate Eia (Orasure Application)Summary page 2…me: None Predicate Device(s) The LZI Opiate Oral Fluid Enzyme Immunoassay is substantially equivalent to the Opiates Intercept® Micro-plate EIA (K981341) manufactured by OraSure Technologies Inc. (formerly known as STC Technologies, Inc) for its general intended use. Device Descri… | 1998 |
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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K062242 (Lin-Zhi International, Inc., 2006) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K981341.
How does its category compare?
All DLG devicesDLG Coating, Liquid, Glc: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DLG
FDA has decided no DLG device since 2007.
Median 510(k) review, days · DLG
Too few DLG 510(k)s in any year since 2007 to give a median.
Recalls per year · DLG
No recall names DLG since 2007.
Adverse event reports per year · DLG
No MAUDE report names DLG 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 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 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Opiate Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay system to detect opiates 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 1 mL of buffer. The calibrators and controls of the analyte Morphine 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…
Read the full statement (154 words)
The Opiate Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay system to detect opiates 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 1 mL of buffer. The calibrators and controls of the analyte Morphine 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 opiate drugs. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Opiate Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassaysystem provides only a preliminary analyticaltest result. A more specific alternative chemical method must be used to obtain a confirmed analyticalresult Gas chromatography/massspectrometry (GC/MS) is the preferred confirmatory method. Clinical considerationandprofessional 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/K050988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050988: Opiate 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/K050988
Report an extraction error
Are you the manufacturer?
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