510(k) · Cleared
ClearedPsychemedics Microplate EIA for Cotinine in Hair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Psychemedics Corporation · MKU Enzyme Immunoassay, Nicotine And Nicotine Metabolites
Cleared on Apr 22, 2020 as substantially equivalent to K974534 (OraSure Technologies, Inc., 1998) after a 222-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Apr 22, 2020
- Review
- 222 days
- Class
- Class I
- Product code
- MKU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974534 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK974534 Micro-Plate Cotinine EiaOraSure Technologies, Inc. · 1998
- This deviceK192517 Psychemedics Microplate EIA for Cotinine in HairPsychemedics Corporation · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974534 | Micro-Plate Cotinine Eia | OraSure Technologies, Inc. | 1998 | — |
| 0 (this device) | K192517 | Psychemedics Microplate EIA for Cotinine in Hair | Psychemedics Corporation | 2020 | — |
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 MKU? 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 |
|---|---|---|---|
| * | K974534 | Micro-Plate Cotinine EiaSummary page 4…ll Date Prepared: April 20, 2020 Device Trade Name: Psychemedics Microplate EIA for Cotinine in Hair, k192517 Predicate Device: STC Micro-Plate Cotinine EIA, k974534 Product Code: MKU Regulation: 862.3220 Carbon monoxide test system Device Classification/Name: Class I, exempt… | 1998 |
| † | K974234 | Micro-Plate Cotinine Eia | 1998 |
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?
- Its one ancestor has no recall.
How does its category compare?
All MKU devicesMKU Enzyme Immunoassay, Nicotine And Nicotine Metabolites: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MKU
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · MKU
Too few MKU 510(k)s in any year since 2007 to give a median.
Recalls per year · MKU
No recall names MKU since 2007.
Adverse event reports per year · MKU
No MAUDE report names MKU since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 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 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 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 Psychemedics Microplate EIA For Cotinine in Hair is an in vitro diagnostic device for the qualitative detection of cotinine in human head and body hair as an aid in the detection of cotinine after use or exposure to tobacco products. The assay is intended for a single site and uses a cutoff calibrator of 200 pg cotinine/mg hair. This device is intended exclusively for Psychemedics use only and is not intended for sale to anyone. The Psychemedics…
Read the full statement (146 words)
The Psychemedics Microplate EIA For Cotinine in Hair is an in vitro diagnostic device for the qualitative detection of cotinine in human head and body hair as an aid in the detection of cotinine after use or exposure to tobacco products. The assay is intended for a single site and uses a cutoff calibrator of 200 pg cotinine/mg hair. This device is intended exclusively for Psychemedics use only and is not intended for sale to anyone.
The Psychemedics Microplate EIA For Cotinine in Hair provides only a preliminary analytical test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Liquid Chromatography/Mass spectrometry/Mass spectrometry (LC/MS/MS) is the confirmatory method used by Psychemedics Corporation. The LC/MS/MS analysis uses a cutoff, after extensive washing of the hair, of 100 pg cotinine/mg hair with presence of hydroxycotinine at or above 10 pg/mg hair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192517: Psychemedics Microplate EIA for Cotinine 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/K192517
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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