510(k) · Cleared
ClearedFirst Check Home Drug Test Panel 4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Worldwide Medical Corp. · LAF Gas Chromatography, Methamphetamine
Cleared on Nov 29, 2000 after a 383-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 later device descends from it.
- Decided
- Nov 29, 2000
- Review
- 383 days
- Class
- Class II
- Product code
- LAF
- Recalls
- None
- Predicates
- 1
1 later device descends from it, 1 citing it directly.
- This deviceK993852 First Check Home Drug Test Panel 4Worldwide Medical Corp. · 2000
- Descendant · cites it directly · 0 of its ownK040629 Accu-Stat Home Drug Test for Marijuana, Cocaine, Amphetamine…Accu-Stat Diagnostics, Inc. · 2004
Most influential descendants
Showing 1 of 1 · See all- K040629Accu-Stat Home Drug Test for Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates…Accu-Stat Diagnostics, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993852 | First Check Home Drug Test Panel 4 | Worldwide Medical Corp. | 2000 | — |
| +1 | K040629 | Accu-Stat Home Drug Test for Marijuana, Cocaine, Amphetamine, Methamphetamine… | Accu-Stat Diagnostics, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 LAF? 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 LAF device
- #1 K203647 SEFRIA Methamphetamine Oral Fluid Enzyme…score 3.8 · 5 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 4 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040629 | Accu-Stat Home Drug Test for Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates… | 2004 | 0 |
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?
- Of its descendants, K040629 (Accu-Stat Diagnostics, Inc., 2004) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LAF devicesLAF Gas Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LAF
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LAF
43in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LAF
No recall names LAF since 2007.
Adverse event reports per year · LAF
No MAUDE report names LAF since 2007.
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 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 345 | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 43 | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 2 | — | 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?
The First Check® Home Drug Test Panel 4 is an educational screening test for the rapid detection of marijuana, cocaine, morphine/opiates, methamphetamine and/or their metabolites in human urine at cut-off levels of 50ng/mL, 300ng/mL, 300ng/mL and 1,000ng/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…
Read the full statement (105 words)
The First Check® Home Drug Test Panel 4 is an educational screening test for the rapid detection of marijuana, cocaine, morphine/opiates, methamphetamine and/or their metabolites in human urine at cut-off levels of 50ng/mL, 300ng/mL, 300ng/mL and 1,000ng/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 four 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/K993852 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993852: First Check Home Drug Test Panel 4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993852
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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