# K042975: Ameditech Immutest Multi-Drug Screen Panel II

- Pathway: 510(k) (Traditional)
- Applicant: Ameditech, Inc.
- Decided: Dec 29, 2004 after 62 days
- Product code: DIS (Enzyme Immunoassay, Barbiturate)
- Device class: 2
- Regulation: 21 CFR 862.3150
- 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K113046: Ameditech Immutest Milti-Drug Screen (2011), 1 descendant of its own
- K113501: Ameditech Checkcup Multi Drug Test (Flat/Round Cup) (2011), 0 descendants of its own
- K051966: First Check Multi Drug Cup 7 for Marijuana (THC), Cocaine (Coc), Amphetamine (Amp), Methamphetamine (Met), Ecstasy (2005), 0 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 Il 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) Barbiturates (BAR) — Secobarbital — 300 Benzodiazepines (BZO) — Oxazepam — 300 3,4methylenedioxymethamphetamine (MDMA) — 3,4methylenedioxymethamphetamine — 500 Methamphetamine (MET1000) — d-Methamphetamine — 1000 Methadone (MTD) — Methadone — 300 Opiates (OPI300) — Morphine — 300 Oxycodone (OXY) — Oxycodone — 100 This test has three types of test format: 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 assay provides only a preliminary result Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method

Source page: https://510kreport.com/device/K042975
Methodology: https://510kreport.com/methodology