510(k) · Cleared
ClearedRapid Drug Screen 3-Panel Test for Cocaine, Marijuana (THC) (Cannabinoids) and Opiates (3 Panel Test for Cto)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Bio Medica Corp. · LDJ Enzyme Immunoassay, Cannabinoids
Cleared on Jan 24, 2000 as substantially equivalent to K984525 (American Bio Medica Corp., 1999) after a 63-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Jan 24, 2000
- Review
- 63 days
- Class
- Class II
- Product code
- LDJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K964900 (1997). No later device cites it as a predicate yet.
- Root · 2 generations backK964900 Rapid Drug ScreenAmerican Bio Medica Corp. · 1997
- 1 generation backK984525 Rapid Drug Screen 5-Panel with Methamphetamine TestAmerican Bio Medica Corp. · 1999
- This deviceK993961 Rapid Drug Screen 3-Panel Test for Cocaine, Marijuana (THC)…American Bio Medica Corp. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964900 | Rapid Drug Screen | American Bio Medica Corp. | 1997 | — |
| −1 | K984525 | Rapid Drug Screen 5-Panel with Methamphetamine Test | American Bio Medica Corp. | 1999 | — |
| 0 (this device) | K993961 | Rapid Drug Screen 3-Panel Test for Cocaine, Marijuana (THC) (Cannabinoids) and… | American Bio Medica Corp. | 2000 | — |
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? (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 |
|---|---|---|---|
| * | K984525 | Rapid Drug Screen 5-Panel with Methamphetamine TestSummary page 1…he requirements of 21 CFR 807.92. The assigned 510(k) is: 1A 61 %% ’ Predicate Device: American Bio Medica “Rapid Drug Screen” 5-Panel Test Kit with Methamphetamine (K-984525). Test Description: All of the assays employed in the Rapid Drug Screen panels are based on the same principle of highly specif… | 1999 |
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 3 years and passes through 1 company; a new generation was cleared every 1.9 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K984525.
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?
“Rapid Drug Screen” 3-Panel Test for Cocaine, THC and Opiates is a one-step, lateral flow immunoassay for the simultaneous detection in urine of three abused drugs at stated detectable limits. (Each assay occupies a separate channel). It is intended for use in the qualitative detection of Cocaine (Benzoyl ecgonine), 300 ng/ml, THC (Cannabinoids), 50 ng/ml) and Opiates, 300 ng/ml. “Rapid Drug Screen” is intended for professional use. It is not intended…
Read the full statement (189 words)
“Rapid Drug Screen” 3-Panel Test for Cocaine, THC and Opiates is a one-step, lateral flow immunoassay for the simultaneous detection in urine of three abused drugs at stated detectable limits. (Each assay occupies a separate channel). It is intended for use in the qualitative detection of Cocaine (Benzoyl ecgonine), 300 ng/ml, THC (Cannabinoids), 50 ng/ml) and Opiates, 300 ng/ml.
“Rapid Drug Screen” is intended for professional use. It is not intended for over the counter sale to non-professionals. The assays are easy to perform, but should not be used without proper supervision. These immuno-assays are simplified qualitative screening methods that provide only a preliminary result for use in the need for additional or confirmatory testing, i.e., gas-chromatography/mass spectrometry (GC/MS).
“Rapid Drug Screen” provides only a preliminary analytical test result. A more specific alternate chemical method must be used to obtain a more confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
“Rapid Drug Screen” is not intended for use as a Point of Care test.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993961: Rapid Drug Screen 3-Panel Test for Cocaine, Marijuana (THC) (Cannabinoids) and Opiates (3 Panel Test for Cto).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993961
Report an extraction error
Are you the manufacturer?
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