510(k) · Cleared
ClearedRapid Tox Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Bio Medica Corp. · LAG High Pressure Liquid Chromatography, Methamphetamine
Cleared on May 30, 2008 as substantially equivalent to K041712 (American Bio Medica Corp., 2004) and 2 other predicates after a 212-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- May 30, 2008
- Review
- 212 days
- Class
- Class II
- Product code
- LAG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K012159 (2001). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K012159 | Rapid Drug Screen | American Bio Medica Corp. | 2001 | — |
| −1 | K023869 | 'Rapidtec'-5M-Multiple Dip Test | American Bio Medica Corp. | 2003 | — |
| 0 (this device) | K073078 | Rapid Tox Cup | American Bio Medica Corp. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 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 LAG? 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? (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 |
|---|---|---|---|
| * | K041712 | 'Rapidtec 4' TestSummary page 1…10 (k) number is: Predicate Device: The Technology utilized in the 'Rapid Tox Cup' is based on the same principle as that utilized in both "Rapid Tec 4,' 5 10O(k) No. K0417 12, 'Rapid Tec 5" 510O(k) No K023 869, and 'Rapid Tox' 510 (k)No. K053359. Test Description: The immunoassays employed in each test… | 2004 |
| * | K023869 | 'Rapidtec'-5M-Multiple Dip TestSummary page 1…e: The Technology utilized in the 'Rapid Tox Cup' is based on the same principle as that utilized in both "Rapid Tec 4,' 5 10O(k) No. K0417 12, 'Rapid Tec 5" 510O(k) No K023 869, and 'Rapid Tox' 510 (k)No. K053359. Test Description: The immunoassays employed in each test strip of the 'Rapid Tox Cup' are b… | 2003 |
| * | K053359 | RapidtoxSummary page 1…apid Tox Cup' is based on the same principle as that utilized in both "Rapid Tec 4,' 5 10O(k) No. K0417 12, 'Rapid Tec 5" 510O(k) No K023 869, and 'Rapid Tox' 510 (k)No. K053359. Test Description: The immunoassays employed in each test strip of the 'Rapid Tox Cup' are based on the same principle of the hi… | 2006 |
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 7 years and passes through 1 company; a new generation was cleared every 5.1 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K041712.
How does its category compare?
All LAG devicesLAG High Pressure Liquid Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LAG
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · LAG
Too few LAG 510(k)s in any year since 2007 to give a median.
Recalls per year · LAG
No recall names LAG since 2007.
Adverse event reports per year · LAG
No MAUDE report names LAG 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 | 1 | — | 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 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 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?
Rapid Tox CupTM is a one-step, lateral flow immunoassay contained in a polypropylene cup for the simultaneous detection of abused drugs in urine. 'Rapid Tox Cup'- is intended for use in the qualitative detection of the following 14 drugs of abuse in human urine at the following levels: Amphetamine 1000 ng/mL Amphetamine 500 ng/mL Methamphetamine 1000 ng/mL Methamphetamine 500 ng/mL 3,4-methylenedioxymethamphetamine (MDMA) 1000 ng/mL…
Read the full statement (287 words)
Rapid Tox CupTM is a one-step, lateral flow immunoassay contained in a polypropylene cup for the simultaneous detection of abused drugs in urine. 'Rapid Tox Cup'- is intended for use in the qualitative detection of the following 14 drugs of abuse in human urine at the following levels:
Amphetamine 1000 ng/mL
Amphetamine 500 ng/mL
Methamphetamine 1000 ng/mL
Methamphetamine 500 ng/mL
3,4-methylenedioxymethamphetamine (MDMA) 1000 ng/mL
3,4-methylenedioxymethamphetamine (MDMA) 500 ng/mL
Buprenorphine 12.5 ng/mL
Benzodiazepines (Oxazepam) 300 ng/mL
Barbiturates (Butalbital) 300 ng/mL
Oxycodone 100 ng/mL
Methadone 300 ng/mL
Phencyclidine 25 ng/mL
Propoxyphene 300 ng/mL
Opiates 300 ng/mL
Opiates 2000 ng/mL
Cocaine (Benzoylecgonine) 300 ng/mL
Cocaine (Benzoylecgonine) 150 ng/mL
Tricyclic Antidepressants (Nortriptyiline) 1000 ng/mL
THC/ Cannabinoids (11 norA9-THC-9-carboxylic acid) 50 ng/mL
'Rapid Tox Cup' is intended for professional use. It is not intended for over-the-counter sale to non-professionals. This assay is a simplified screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. gas-chromatography/mass spectrometry (GC/MS).
The barbiturate BAR, benzodiazepine BZO and tricyclic antidepressant TCA will yield preliminary positive results when BAR, BZO, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, or tricyclic antidepressant in urine. Certain foods or medicines may interfere with tests for Barbiturates, Benzodiazepines, and Tricyclic Antidepressants and may cause positive results.
There is no calibration necessary and therefore no calibrator needed for this device.
'Rapid Tox Cup' provides only a preliminary analytical result. A more specific alternate method must be used in order to obtain a more confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse result, particularly when preliminary positive results are used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073078 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073078: Rapid Tox Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073078
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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