510(k) Report

510(k) · Cleared

Cleared

Psychemedics Ria Methamphetamine and Mdma Assay

K011185510(k) TraditionalCleared Jan 24, 2002281-day reviewClass II21 CFR 862.3610

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Psychemedics Corp. · DJC Thin Layer Chromatography, Methamphetamine

Cleared on Jan 24, 2002 after a 281-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Jan 24, 2002
Review
281 days
Class
Class II
Product code
DJC
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2021: 1 descendant cleared200020052010201520202025
  1. This deviceK011185 Psychemedics Ria Methamphetamine and Mdma AssayPsychemedics Corp. · 2002
  2. Descendant · cites it directly · 1 of its ownK111927 Psychemedics Methamphetamine EiaPsychemedics Corp. · 2012
  3. Descendant · 2 generations on · 0 of its ownK210212 Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairPsychemedics Corporation · 2021

Most influential descendants

Showing 2 of 2 · See all
  • K111927Psychemedics Methamphetamine EiaPsychemedics Corp. · 2012 · cites it directly1descendant
  • K210212Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairPsychemedics Corporation · 2021 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011185Psychemedics Ria Methamphetamine and Mdma AssayPsychemedics Corp.2002—
+1K111927Psychemedics Methamphetamine EiaPsychemedics Corp.2012—
+2K210212Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairPsychemedics Corporation2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
202110
FIG. 1 — Lineage of K011185, 2002–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DJC? 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 DJC device

  1. #1 K253705 Healgen® Accurate Oral Fluid Drug Testscore 12.2 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K111927Psychemedics Methamphetamine EiaPsychemedics Corp.20121

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?

  • Of its descendants, K111927 (Psychemedics Corp., 2012) has gone furthest, with 1 descendant of its own.

How does its category compare?

All DJC devices

DJC Thin Layer Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DJC

1in 2025

2008: 12013: 12016: 12018: 32025: 12026 (partial year): 1
2007high 3 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DJC

258in 2018

2018: 258 days median
2007high 258 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DJC

No recall names DJC since 2007.

Adverse event reports per year · DJC

2in 2018

2017: 12018: 2
2007high 2 (2018) · low 0 (2007)2025

MAUDE reports naming product code DJC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20081—00
20090—00
20100—00
20110—00
20120—00
20131—00
20140—00
20150—00
20161—00
20170—01
2018325802
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20251—00
20261—0—

More from Psychemedics Corp.

12 FDA decisions under this applicant name. See the company

  • K130811Psychemedics Microplate Eia for AmphetaminePsychemedics Corp. · 2013
  • K123799Psychemedics Microplate Eia for Oxycodone in HairPsychemedics Corp. · 2013
  • K111927Psychemedics Methamphetamine EiaPsychemedics Corp. · 2012
  • K111926Psychemedics Opiates EiaPsychemedics Corp. · 2012
  • K111928Psychemedics Phencyclidine EiaPsychemedics Corp. · 2012

Recent decisions in DJC

The DJC category page

  • K253705Healgen® Accurate Oral Fluid Drug TestHealgen Scientific,, LLC · 2026
  • K240287LYHER® Oral fluid Multi-Drug Test Kit (Cube)Hangzhou Laihe Biotech Co., Ltd. · 2025
  • K180878BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC…Shanghai Venture Bio-Tech Co., Ltd. · 2018
  • K181305OralTox Oral fluid Drug TestPremier Biotech, Inc. · 2018
  • K171403OralTox Oral Fluid Drug TestPremier Biotech, Inc. · 2018

https://510kreport.com/device/K011185 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011185: Psychemedics Ria Methamphetamine and Mdma Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011185

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026