510(k) · Cleared
ClearedPsychemedics Methamphetamine Eia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Psychemedics Corp. · LAF Gas Chromatography, Methamphetamine
Cleared on May 1, 2012 as substantially equivalent to K011185 (Psychemedics Corp., 2002) after a 300-day review. Its family tree reaches back 1 generation to 2002. 1 later device descends from it.
- Decided
- May 1, 2012
- Review
- 300 days
- Class
- Class II
- Product code
- LAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011185 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK011185 Psychemedics Ria Methamphetamine and Mdma AssayPsychemedics Corp. · 2002
- This deviceK111927 Psychemedics Methamphetamine EiaPsychemedics Corp. · 2012
- Descendant · cites it directly · 0 of its ownK210212 Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairPsychemedics Corporation · 2021
Most influential descendants
Showing 1 of 1 · See all- K210212Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairPsychemedics Corporation · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011185 | Psychemedics Ria Methamphetamine and Mdma Assay | Psychemedics Corp. | 2002 | — |
| 0 (this device) | K111927 | Psychemedics Methamphetamine Eia | Psychemedics Corp. | 2012 | — |
| +1 | K210212 | Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair | Psychemedics Corporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K011185 | Psychemedics Ria Methamphetamine and Mdma AssaySummary page 2…to the interpretation of any drug-of- abuse test result. 510k K111927 K011185 Measurand Metbarnphetamini Methamphetamine Matrix Human head or body hai… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210212 | Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair | 2021 | 0 |
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, K210212 (Psychemedics Corporation, 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LAF devicesLAF Gas Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Psychemedics Microplate EIA for Methamphietamine is an enzyme immunoassay (ETA) for the preliminary qualitative detection of methamphetamine in human head and body hair samples using a methamphetamine calibrator at 5 ng /10 mng hair cutoff for the purpose of identifying methamphetamine use; This product is intended exclusively for in-house professional use only and is not for sale to anyone. The Psychemedics Microplate ETA for Methamphetarnine in…
Read the full statement (114 words)
The Psychemedics Microplate EIA for Methamphietamine is an enzyme immunoassay (ETA) for the preliminary qualitative detection of methamphetamine in human head and body hair samples using a methamphetamine calibrator at 5 ng /10 mng hair cutoff for the purpose of identifying methamphetamine use; This product is intended exclusively for in-house professional use only and is not for sale to anyone.
The Psychemedics Microplate ETA for Methamphetarnine in Hair provides. only a preliminary analytical test result. To confirm a presumptive screen positiv'e result, a more specific alternate chemical method such as LC/MS/MS (liquid chromatography/mass spectrometry/mass spectrometry) must be used. Clinical consideration and professional judgment must be applied to the interpretation of any drug-of-abuse test result.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111927 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111927: Psychemedics Methamphetamine Eia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111927
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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