510(k) · Cleared
ClearedQuest Diagnostics Methamphetamine Micro-Plate Eia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quest Diagnostics, Inc. · LAF Gas Chromatography, Methamphetamine
Cleared on Jun 25, 2008 after a 133-day review. The FDA summary names its predicate without a number.
- Decided
- Jun 25, 2008
- Review
- 133 days
- Class
- Class II
- Product code
- LAF
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | Orasure Methamphetamine Intercept® Micro-Plate EIA Named without a submission number |
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.
How does its category compare?
All LAF devicesLAF Gas Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Quest Diagnostics Methamphetamine Micro-Plate EIA is intended for the qualitative detection of Methamphetamine in oral fluid collected with the OrasureTM Oral Specimen Collection Device. It is a screen test with a cutoff of 40 ng/ml. The Quest Diagnostics Methamphetamine Micro-Plate EIA provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a…
Read the full statement (180 words)
The Quest Diagnostics Methamphetamine Micro-Plate EIA is intended for the qualitative detection of Methamphetamine in oral fluid collected with the OrasureTM Oral Specimen Collection Device. It is a screen test with a cutoff of 40 ng/ml.
The Quest Diagnostics Methamphetamine Micro-Plate EIA provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain confirmed analytical results a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.
The Quest Diagnostics Methamphetamine Micro-Plate EIA Calibrators are intended for medical purposes and for use only with the Quest Diagnostics Methamphetamine Micro-Plate EIA to establish points of reference that are used in the measurement of methamphetamine in oral fluid samples collected with OraSureT Oral Specimen Collection Device.
The Quest Diagnostics Methamphetamine Micro-Plate EIA Controls are intended for use as an assay quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for methamphetamine in oral fluid samples collected with OraSure TM Oral Specimen Collection Device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080381: Quest Diagnostics Methamphetamine Micro-Plate Eia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080381
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026