510(k) · Cleared
ClearedFirst Check Home Drug Test Panel 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Worldwide Medical Corp. · LDJ Enzyme Immunoassay, Cannabinoids
Cleared on Jun 23, 2000 after a 199-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- Jun 23, 2000
- Review
- 199 days
- Class
- Class II
- Product code
- LDJ
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
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? (2)
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 |
|---|---|---|---|
| Kept off the family tree | K972425 | Applied Biotech SureStep™ Drug Screen Multi 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 2…ty and Effectiveness: Because the First Check® Home Drug Test Panel 2 is identical to the Applied Biotech SureStep™ Drug Screen Multi Test that is legally marketed under K972425, and because no special skills, training, education, or licensure are required to transfer a dropper level of urine sample into t… | |
| * | — | Phamatech QuickScreen™ At Home Drug Test 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.
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 First Check® Home Drug Test Panel 2 is an educational screening test for the rapid detection of marijuana and cocaine and/or their metabolites in human urine at cut-off levels of 50ng/mL and 300ng/mL, respectively. The test is intended for consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the two drugs listed above in a human urine sample. Such information is beneficial to consumer efforts to comply with applicable laws and/or societal expectations. Information regarding second step confirmatory testing is provided.
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/K994139 · printed Nov 5, 2026
Cite this page
510(k) Report. “K994139: First Check Home Drug Test Panel 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K994139
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026