# K993852: First Check Home Drug Test Panel 4

- Pathway: 510(k) (Traditional)
- Applicant: Worldwide Medical Corp.
- Decided: Nov 29, 2000 after 383 days
- Product code: LAF (Gas Chromatography, Methamphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3610
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).
- (no number) Phamatech QuickScreen™ At Home Drug Test: named in the summary without a submission number

## Cited in the summary but 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.

## Most influential descendants
- K040629: Accu-Stat Home Drug Test for Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine (2004), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K993852
Methodology: https://510kreport.com/methodology