510(k) · Cleared
ClearedAccu-Stat Home Drug Test Cup for Maijuanna (THC), Cocaine (Coc), Amphetamine (Amp), Methamphetamine (Mamp), Ecstasy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accu-Stat Diagnostics, Inc. · LDJ Enzyme Immunoassay, Cannabinoids
Cleared on Jul 13, 2004 as substantially equivalent to K031759 (ACON Laboratories, Inc., 2003) after a 64-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Jul 13, 2004
- Review
- 64 days
- Class
- Class II
- Product code
- LDJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K945610 (1995). 19 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 3 generations backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- 2 generations backK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
- 1 generation backK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
- This deviceK041221 Accu-Stat Home Drug Test Cup for Maijuanna (THC), Cocaine (Coc)…Accu-Stat Diagnostics, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −3 | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | ACON Laboratories, Inc. | 2001 | — |
| −2 | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | Acon Laboratories Co. | 2002 | — |
| −1 | K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum… | ACON Laboratories, Inc. | 2003 | 1 |
| 0 (this device) | K041221 | Accu-Stat Home Drug Test Cup for Maijuanna (THC), Cocaine (Coc), Amphetamine… | Accu-Stat Diagnostics, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 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 LDJ? 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 LDJ device
- #1 K232732 Rapid Marijuana (THC) Test Strip 20, Rapid…score 9.4 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum Multi-Drug…Summary page 3…(OPI), and Phencyclidine (PCP) are identical to the ACON Laboratories One Step Multi-Drug Multi-Line Screen Test Card with Integrated Cup that is legally marketed under K031759 for professional use, and because no special skills, training, education, or licensing is required to collect a urine specimen an… | 2003 |
| * | — | Phamatech At Home Drug Test Cup Named without a submission number | |
| * | — | First Check Home Drug Tests Named without a submission number |
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 9 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 19 ancestors has a recall of any class.
- 2 other devices also cite its predicate K031759.
How does its category compare?
All LDJ devicesLDJ Enzyme Immunoassay, Cannabinoids: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LDJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LDJ
48in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LDJ
1in 2015
MAUDE reports naming product code LDJ, not matched to any one device; reports are not rates.
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 | — | 4 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 219 | 0 | 0 |
| 2012 | 4 | 193 | 0 | 0 |
| 2013 | 3 | 162 | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 48 | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 1 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Accu-Stat MT Drugs of Abuse Home Test Cup for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Ecstasy (MDMA), Opiates (OPI), and Phencyclidine (PCP), is a screening test for the rapid detection of three to seven of the above listed drugs in a variety of combinations human urine. The designated cut-off concentrations for these drugs are as follows: Marijuana at 50 ng/ml, Cocaine at 300 ng/ml, Amphetamine at 1000 ng/ml…
Read the full statement (159 words)
The Accu-Stat MT Drugs of Abuse Home Test Cup for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Ecstasy (MDMA), Opiates (OPI), and Phencyclidine (PCP), is a screening test for the rapid detection of three to seven of the above listed drugs in a variety of combinations human urine. The designated cut-off concentrations for these drugs are as follows: Marijuana at 50 ng/ml, Cocaine at 300 ng/ml, Amphetamine at 1000 ng/ml, Methamphetamine at 1000 ng/ml, Ecstasy at 500 ng/ml, Opiates at 2000 ng/ml, and Phencyclidine at 25 ng/ml. The tests are intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information, along with the materials for shipping a portion of the urine specimen to the laboratory for confirmation testing of a preliminary positive result, the second step in the process, is provided.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041221: Accu-Stat Home Drug Test Cup for Maijuanna (THC), Cocaine (Coc), Amphetamine (Amp), Methamphetamine (Mamp), Ecstasy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041221
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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