510(k) · Cleared
ClearedRoche Fludi Methamphetamine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · LAF Gas Chromatography, Methamphetamine
Cleared on Feb 25, 2011 as substantially equivalent to K993208 (OraSure Technologies, Inc., 2000) after a 434-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Feb 25, 2011
- Review
- 434 days
- Class
- Class II
- Product code
- LAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K933052 (1993). No later device cites it as a predicate yet.
- Root · 2 generations backK933052 Abuscreen Online (R) for Amphetamines, ModifiedRoche Diagnostic Systems, Inc. · 1993
- 1 generation backK993208 STC Methamphetamine Intercept Micro-Plate Eia, Model 1104IOraSure Technologies, Inc. · 2000 · Recalled
- This deviceK093884 Roche Fludi MethamphetamineRoche Diagnostics · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933052 | Abuscreen Online (R) for Amphetamines, Modified | Roche Diagnostic Systems, Inc. | 1993 | — |
| −1 | K993208 | STC Methamphetamine Intercept Micro-Plate Eia, Model 1104I | OraSure Technologies, Inc. | 2000 | 1 |
| 0 (this device) | K093884 | Roche Fludi Methamphetamine | Roche Diagnostics | 2011 | — |
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 |
|---|---|---|---|
| * | K993208 | STC Methamphetamine Intercept Micro-Plate Eia, Model 1104ISummary page 2…claim substantial equivalence to the currently marketed Methamphetamine Intercept® Micro-Plate ELA assay (K993208). _____ ____Comparison Table Feature… | 2000 |
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.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 10.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 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. 2011, 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?
DAT Oral Fluid Methamphetamine (OFMA) is an in vitro diagnostic test for the qualitative and semi quantitative detection of methamphetamine in human oral fluid at a cutoff concentration of 120 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Intercept® Oral Specimen Collection Device. Semniquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program and to…
Read the full statement (256 words)
DAT Oral Fluid Methamphetamine (OFMA) is an in vitro diagnostic test for the qualitative
and semi quantitative detection of methamphetamine in human oral fluid at a cutoff
concentration of 120 ng/mL in neat oral fluid. The specimen must be collected exclusively
with the Intercept® Oral Specimen Collection Device. Semniquantitative test results may be
obtained that permit laboratories to assess assay performance as part of a quality control
program and to estimate a dilution of the specimen for confirmation by a confirmatory
method such as LC/MS/MS.
DAT Oral Fluid Methamphetamine provides only a preliminary analytical test result. A
more specific alternate chemical method must be used in order to obtain a confirmed
analytical result. Chromatography/mass spectrometry 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.
The Oral Fluid DAT Control Set A is for use as assayed controls with the DAT Oral
Fluid assays on automated clinical chemistry analyzers for human oral fluid samples
collected with the Intercept Oral Specimen Collection Device.
The Oral Fluid DAT Qual Cal calibrators are designed for the calibration of oral fluid
assays for drugs of abuse on automated clinical chemistry analyzers for human oral fluid
samples collected with the Intercept Oral Specimen Collection Device.
The Oral Fluid DAT SQ Cal A calibrators are designed for the calibration of oral fluid
assays for drugs of abuse on automated clinical chemistry analyzers for human oral fluid
samples collected with the Intercept Oral Specimen Collection Device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093884 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093884: Roche Fludi Methamphetamine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093884
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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