510(k) · Cleared
ClearedRadid Drug Screen 5-Panel Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Bio Medica Corp. · DJG Enzyme Immunoassay, Opiates
Cleared on Jan 10, 2000 as substantially equivalent to K990820 (American Bio Medica Corp., 1999) and 3 other predicates after a 111-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Jan 10, 2000
- Review
- 111 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K990818 (1999). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK990818 Rapidone - Marijuana TestAmerican Bio Medica Corp. · 1999
- This deviceK993151 Radid Drug Screen 5-Panel TestAmerican Bio Medica Corp. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990818 | Rapidone - Marijuana Test | American Bio Medica Corp. | 1999 | — |
| 0 (this device) | K993151 | Radid Drug Screen 5-Panel Test | American Bio Medica Corp. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 3 | 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 DJG? 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 DJG device
- #1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K990820 | Rapidone - Opiates TestSummary page 1…ance with the requirements of 21 CFR 807.92. The assigned 510(k) number is: __K993151 Predicate Device: American Bio Medica ‘RapidOne’ Single Tests: Opiates 510(k) No.K990820 Marijuana 510(k) No.K990822 Cocaine 510(k) No.K990822 Amphetamine 510(k) No.K992452 And Forefront Diagnostics ‘InstaCheck’ PCP 5… | 1999 |
| * | K990822 | Rapidone - Cocaine TestSummary page 1…f 21 CFR 807.92. The assigned 510(k) number is: __K993151 Predicate Device: American Bio Medica ‘RapidOne’ Single Tests: Opiates 510(k) No.K990820 Marijuana 510(k) No.K990822 Cocaine 510(k) No.K990822 Amphetamine 510(k) No.K992452 And Forefront Diagnostics ‘InstaCheck’ PCP 510(k) No.K980084 Test Descr… | 1999 |
| * | K990818 | Rapidone - Marijuana TestSummary page 2…Screen’-5-Panel is substantially equivalent to a combination of the following: ‘RapidOne’ Opiates Test K990820 ‘RapidOne’ Cocaine Test K990822 ‘RapidOne’ Marijuana Test K990818 ‘RapidOne’ Amphetamine Test K992452 ‘InstaCheck’ PCP Test K980084 Food and Drug Administration 2098 Gaither Road… | 1999 |
| * | K992452 | Rapidone-Amphetamine Test Cleared while this submission was under review Summary page 1…51 Predicate Device: American Bio Medica ‘RapidOne’ Single Tests: Opiates 510(k) No.K990820 Marijuana 510(k) No.K990822 Cocaine 510(k) No.K990822 Amphetamine 510(k) No.K992452 And Forefront Diagnostics ‘InstaCheck’ PCP 510(k) No.K980084 Test Description: The assays employed in the ‘Rapid Drug Screen’-… | 1999 |
| Kept off the family tree | K980084 | ‘InstaCheck’ PCP Test Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…sts: Opiates 510(k) No.K990820 Marijuana 510(k) No.K990822 Cocaine 510(k) No.K990822 Amphetamine 510(k) No.K992452 And Forefront Diagnostics ‘InstaCheck’ PCP 510(k) No.K980084 Test Description: The assays employed in the ‘Rapid Drug Screen’-5-Panel are based on the same principle of highly specific rea… |
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?
- None of the 4 ancestors has a recall.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DJG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJG
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJG
1in 2025
MAUDE reports naming product code DJG, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 187 | 0 | 0 |
| 2011 | 6 | 233 | 1 | 4 |
| 2012 | 5 | 95 | 0 | 1 |
| 2013 | 5 | 60 | 0 | 4 |
| 2014 | 9 | 62 | 0 | 0 |
| 2015 | 12 | 141 | 0 | 3 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 4 | 101 | 0 | 1 |
| 2018 | 5 | 134 | 0 | 1 |
| 2019 | 3 | 235 | 1 | 0 |
| 2020 | 5 | 30 | 0 | 0 |
| 2021 | 3 | 422 | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 10 | 140 | 0 | 0 |
| 2024 | 5 | 150 | 0 | 3 |
| 2025 | 3 | 31 | 2 | 1 |
| 2026 | 3 | 157 | 0 | — |
What is it indicated for?
‘Rapid Drug Screen’ 5-Panel test is a one-step, lateral flow immunoassay for the simultaneous detection of 5 abused substances in urine (each assay occupies a separate channel). ‘Rapid Drug Screen’ 5-Panel test is intended for use in the qualitative detection of the following 5 drugs of abuse in human urine at the following levels: d-Amphetamine 1000 ng/ml Benzoyl ecgonine 300 ng/ml Cannabinoids 50 ng/ml Opiates 300 ng/ml Phencyclidine (PCP) 25 ng/ml…
Read the full statement (195 words)
‘Rapid Drug Screen’ 5-Panel test is a one-step, lateral flow immunoassay for the simultaneous detection of 5 abused substances in urine (each assay occupies a separate channel). ‘Rapid Drug Screen’ 5-Panel test is intended for use in the qualitative detection of the following 5 drugs of abuse in human urine at the following levels:
d-Amphetamine 1000 ng/ml
Benzoyl ecgonine 300 ng/ml
Cannabinoids 50 ng/ml
Opiates 300 ng/ml
Phencyclidine (PCP) 25 ng/ml
‘Rapid Drug Screen’ 5-Panel test is intended for professional use. It is not intended for over the counter sale to non-professionals. The assay is easy to perform, but should not be used without proper supervision. This immunoassay is a simplified qualitative 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).
‘Rapid Drug Screen’ 5-Panel test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order 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.
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/K993151 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993151: Radid Drug Screen 5-Panel Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993151
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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