# K050186: Ameditech Immutest Multi-Drug Screen Panel Iii

- Pathway: 510(k) (Traditional)
- Applicant: Ameditech, Inc.
- Decided: Mar 4, 2005 after 36 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K052115: First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc), Amphetamine (Amp), Methamphetamine (Met), Ecstasy (2005), 18 descendants of its own
- K143187: Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card) (2015), 4 descendants of its own
- K142280: Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card) (2014), 4 descendants of its own
- K141647: Healgen Coc One Step Cocaine Test Strip:Morhpine Test Strip (Cassette, Cup, Dip Card) (2014), 4 descendants of its own
- K140546: Healgen THC One Step Marijuana Test , Healgen Mamp One Step Methamphetamine Test (2014), 4 descendants of its own

## Recalls of this device
- Apr 26, 2011 · Not classified · Z-2670-2011: The recall was initiated because Ameditech's internal review of regulatory files found that the two affected lots were manufactured without proper regulatory clearance.
- Mar 18, 2011 · Not classified · Z-2387-2011: Express Diagnostics Int'l, Inc. has initiated a medical device recall on various model numbers of DrugCheck devices, This recall was due to incorrect product expiration dating after findings from an F
- Nov 1, 2010 · Not classified · Z-3104-2011: Express Diagnostics Intl'l Inc is recalling DrugCheck devices because they were informed via letter from the alcohol test strip manufacturer on October 27, 2010 that the product was not 510 K cleared 

## Indications for use
The Ameditech ImmuTest Multi-Drug Screen Panel III is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. The cutoff concentrations for this panel test are as follows. Test — Calibrator — Cutoff (ng/ml) Cocaine metabolite (COC) — Benzoylecgonine — 300 Tetrahydrocannabinol (THC) — I l-nor-A9-THC-9-COOH — 50 Methamphetamine (MET 1000) — Methamphetamine — 1000 Opiates (OPI) — Morphine — 2000 Phencyclidine (PCP) — Phencyclidine — 25 Amphetamine (AMP) — Amphetamine — 1000 Barbiturates (BAR) — Secobarbital — 300 Benzodiazepines (BZO) — Oxazepam — 300 Methadone (MTD) — Methadone — 300 Tricyclic Antidepressants (TCA) — Nortriptyline — 1000 Oxycodone (OXY) — Oxycodone — 100 3,4methylenedioxymethamphetamine (MDMA) — 3,4methylenedioxymethamphetamine — 500 This test uses multiple test strips in card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder). This test is used to obtain a visual, qualitative result and is intended for professional use. This assayprovides only a preliminary result. Clinical considerationandprofessional judgment must be applied to any drug of abuse test result, particularlyin evaluating a preliminarypositive result.In order to obtain a confirmed analyticalresult, a more specific alternatechemical method is needed. Gas Chromatography/MassSpectroscopy (GC/MS) is the preferred confirmation method.

Source page: https://510kreport.com/device/K050186
Methodology: https://510kreport.com/methodology