510(k) · Cleared
ClearedPsychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Psychemedics Corporation · LAF Gas Chromatography, Methamphetamine
Cleared on Dec 15, 2021 as substantially equivalent to K111927 (Psychemedics Corp., 2012) and 1 other predicate after a 322-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Dec 15, 2021
- Review
- 322 days
- Class
- Class II
- Product code
- LAF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K933052 (1993). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK933052 Abuscreen Online (R) for Amphetamines, ModifiedRoche Diagnostic Systems, Inc. · 1993
- 3 generations backK992918 STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103IOraSure Technologies, Inc. · 2000
- 2 generations backK033743 Cozart Eia Amphetamines Oral Fluid Microplate KitCozart Bioscience, Ltd. · 2004
- 1 generation backK130811 Psychemedics Microplate Eia for AmphetaminePsychemedics Corp. · 2013
- This deviceK210212 Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairPsychemedics Corporation · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933052 | Abuscreen Online (R) for Amphetamines, Modified | Roche Diagnostic Systems, Inc. | 1993 | — |
| −3 | K992918 | STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103I | OraSure Technologies, Inc. | 2000 | — |
| −2 | K033743 | Cozart Eia Amphetamines Oral Fluid Microplate Kit | Cozart Bioscience, Ltd. | 2004 | — |
| −1 | K130811 | Psychemedics Microplate Eia for Amphetamine | Psychemedics Corp. | 2013 | — |
| 0 (this device) | K210212 | Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair | Psychemedics Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2012 | 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
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K111927 | Psychemedics Methamphetamine EiaSummary page 4…Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair Predicate Device: Psychemedics Microplate EIA for Methamphetamine in Hair, k111927; Psychemedics Microplate EIA for Amphetamine in Hair, k130811 Product Code:… | 2012 |
| * | K130811 | Psychemedics Microplate Eia for AmphetamineSummary page 4…Psychemedics Microplate EIA for Methamphetamine in Hair, k111927; Psychemedics Microplate EIA for Amphetamine in Hair, k130811 Product Code: LAF (Methamphetamine Test System), DKZ (Amphetamine Test System) Device/Classification Nam… | 2013 |
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 28 years and passes through 5 companies; a new generation was cleared every 8.6 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All LAF devicesLAF Gas Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 homogeneous enzyme immunoassay (HEIA) for amphetamines in hair is an enzyme immunoassay system for the preliminary qualitative detection of methamphetamine in human head and body hair using a methamphetamine calibrator at 3 ng methamphetamine/10 mg hair or 5 ng methamphetamine/10 mg hair for the purpose of identifying methamphetamine use, and for the preliminary qualitative detection of amphetamine in human head and body hair using an…
Read the full statement (143 words)
The Psychemedics homogeneous enzyme immunoassay (HEIA) for amphetamines in hair is an enzyme immunoassay system for the preliminary qualitative detection of methamphetamine in human head and body hair using a methamphetamine calibrator at 3 ng methamphetamine/10 mg hair or 5 ng methamphetamine/10 mg hair for the purpose of identifying methamphetamine use, and for the preliminary qualitative detection of amphetamine in human head and body hair using an amphetamine calibrator at 3 ng amphetamine/10 mg hair for the purpose of identifying amphetamine use.
This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not for sale to anyone. The Psychemedics HEIA for amphetamines in hair provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC/MS/MS) is the preferred confirmatory method.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210212 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210212: Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210212
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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