510(k) K052115 ยท DKZ Enzyme Immunoassay, Amphetamine
FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY
| Applicant | First Check Diagnostics, LLC, Lake Forest CA, US |
| Decision | Substantially Equivalent, Dec 29, 2005 |
| Received | Aug 4, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052115
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2020 | Ameditech Inc Alere iCup Drug Detection (AMT Item Number/ AMT Description):
I-DXA-10/ "Alere" iCup Dx 10 Drug Detection + Adulteration AMP/BAR/BZO/COC/MET/MDMA/MTD/MOP/OXY/THC
Bl, Cr, Ni, pH, SG",
I-DXA-13B/"Aler Terminated |
DIO | None listed |
| Aug 18, 2020 | Ameditech Inc ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description):
IMCA-5AB-W / "ImmuTest Drugs of Abuse Cup
AMP1000+BZO300+COC300+OPI2000+THC50
With Cr, Ni, pH, Bl, S.G.",
IMC-8BBCE/ "ImmuTest Drugs Terminated |
DKC | None listed |
| Aug 18, 2020 | Ameditech Inc ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description):
PSD-6MB/ "ProScreen" Drugs of Abuse Test
(MET1000/OPI2000)+AMP+BZO+COC+THC",
PSD-6MTDBO-300 /"ProScreen" Drugs of Abuse Test
(COC/THC)+BZO Terminated |
DKC | None listed |
| Aug 18, 2020 | Ameditech Inc First Check 1 Panel Drug Cup: (THC); AMT Item Number 990400B Terminated |
DKC | None listed |
| Aug 18, 2020 | Ameditech Inc First Check 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600B Terminated |
DKZ | None listed |
| Aug 18, 2020 | Ameditech Inc First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Number 990100B Terminated |
DKZ | None listed |
| Aug 18, 2020 | Ameditech Inc First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC); AMT Item Number 990100B Terminated |
DKZ | None listed |
| Nov 16, 2015 | Ameditech Inc 1 Step 12 Panel Cup, Item No. NBCA-12M-W Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc 10-Panel Pipette Drug Screen, Item No. PSP-10M Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc 11 Panel Card (OPI 300) w/Adult, Item No. 71125AA Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc 12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP, PSD-6MTDBO300, PSD-10PPX, PSD-10MOX, 60960D, 61127D, DCC-81205-5,
IMCA-10M5. Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc BZO Strip Dip Card (300ng/ml)*, Item No. 100170 Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5 Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5 Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc DrugSmart 11 Test Cup, Item No. 61127D Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D
DrugSmart 12 Test Cup (Multi/Single/BUP), Item No. 61205D Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc DrugSmart 9 Test Cup (BUP), Item No. 60960D Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc DrugSmart Cup 10, Item No. 61093D-3C, 61085D, 61015D Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc DrugSmart Cup THC/COC/AMP//MET/OPI2/BZO, Item No. 60600D Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc EDI BZO Uncut Sheet - Cup*, Item No. 160170 Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142 Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc iCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131 Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023 Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013 Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016 Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5 Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-11OP Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc ImmuTest 12 Panel Dip Card, Item No. IMD-12MO3 Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc ImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7P Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc Immutest Cup CLIA Waived w/Adulteration, Item No. IMCA-7MT-W Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc ProScreen 10 Drug Panel Cassette Test, Item No. PSP-10PPX Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc ProScreen 10 Panel Cup, Item No. PSCup-10M Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc ProScProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc ProScreen 10 Panel Dip Card, Item No. PSD-10MOX, PSD-10MOB, PSD-10MMO300 Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO300,
PSDA-10PPX, PSDA-10BUP, PSD-12BUP, PSD-10M, PSCupA-6MB-W,
PSCup-10MMO300, PSD-5AB, PSD-10CMO3, PSCupA-10MO, PSCupA-12M-W
I-DXA-1 Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc ProScreen 12 Panel Dip Card, Item No. PSD-12BUP Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc ProScreen 5 Panel Dip Card, Item No. PSD-12BUP Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc ProScreen 5 Panel Dip Card w/Adult, Item No. PSDA-5MB300 Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc ProScreen 6 Panel Dip Card, Item No. PSCuPSD-6BUP300, PSD-6MTDBO300,
PSD-6BUPO, PSD-6MBO, PSD-6MB, Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc ProScreen 6 Panel Dip Card w/Adult (AU), Item No. PSDA-6MBAU Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc ProScreen 6 Panel Dip Drug Screen, Item No. PSD-6BUPO3 Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc ProScreen 7 Panel Dip Card, Item No. PSD-7MPB, PSD-7MO, PSD-7M Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc ProScreen 8 Panel Dip Card, Item No. PSD-8P Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300 Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc ProScreen 9 Panel Cup w/Adulterants, Item No. PSCUPA-9BO300 Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc ProScreen CLIA Wvd 12 Panel Cup w/Adult., Item No. PSCupA-12M-W Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc RealityCHECK Tilt Cup 12 Panel + Adult, Item No. RC12TCA Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc THERMO FISHER 8 DRUG CASSETTE, Item No. MTPA-8MBAU Terminated |
JXM | None listed |
| Oct 20, 2015 | Ameditech Inc 1 Step 12 Panel Cup, Item No. NBCA-12M-W
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of Terminated |
JXM | None listed |
| Oct 20, 2015 | Ameditech Inc 10-Panel Pipette Drug Screen, Item No. PSP-10M
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurati Terminated |
JXM | None listed |
| Oct 20, 2015 | Ameditech Inc 11 Panel Cup (OPI2000) w/Adult, Item No. 71125AA2K
; and 11 Panel Cup (OPI300) w/Adult, Item No. 71125AA
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple Terminated |
JXM | None listed |
| Oct 20, 2015 | Ameditech Inc 11 Panel Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple d Terminated |
JXM | None listed |
| Oct 20, 2015 | Ameditech Inc 12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. Terminated |
JXM | None listed |
| Oct 20, 2015 | Ameditech Inc ArcPoint Labs 10 Panel Dip Screen (OXY), Item No. APD-10MO
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The Terminated |
JXM | None listed |
| Oct 20, 2015 | Ameditech Inc CLIA RDTC 12-Panel Cup and CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug Terminated |
JXM | None listed |
| Oct 20, 2015 | Ameditech Inc DrugCheck Pipette 10 Drug Test, Item No. 41025 DC
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configur Terminated |
JXM | None listed |
| Oct 20, 2015 | Ameditech Inc DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. Th Terminated |
JXM | None listed |
| Oct 20, 2015 | Ameditech Inc DrugSmart 10 Test Cup (PCP & MDMA), Item No. 61055D;
DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple d Terminated |
JXM | None listed |
| Oct 20, 2015 | Ameditech Inc DrugSmart 11 Test Cup, Item No. 61127D;
DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D;
DrugSmart 9 Test Cup (BUP), Item No. 60960D;
DrugSmart Cup 10, Item No. 61093D-3C
These Drugs of Abuse Te Terminated |
JXM | None listed |
| Oct 20, 2015 | Ameditech Inc DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D;
DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection o Terminated |
JXM | None listed |
| Oct 20, 2015 | Ameditech Inc EDI BZO UNCUT SHEET-CARD, Item No. 100170
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations o Terminated |
JXM | None listed |
| Oct 20, 2015 | Ameditech Inc iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013;
iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142;
iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131;
iCup DX 12 Panel w/Adultera Terminated |
JXM | None listed |
| Oct 20, 2015 | Ameditech Inc Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5;
Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP;
Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-12BUP;
Immutest 5 panel, Terminated |
JXM | None listed |
| Oct 20, 2015 | Ameditech Inc Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. Terminated |
JXM | None listed |
| Oct 20, 2015 | Ameditech Inc Premier Clia Waived 12 panel Tilt Cup, Item No. C12APC
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The co Terminated |
JXM | None listed |
| Oct 20, 2015 | Ameditech Inc ProScreen 10 Drug Panel Cassette Test, Item No. CPSP-10PPX;
ProScreen 10 Panel Cup, Item No. PSCup-10MMO-300, PSCup-10M,
PSCupA-10MO, PSCUp-10AB;
ProScreen 10 Panel Cup with Adulterants, Item No. PSCu Terminated |
JXM | None listed |
| Oct 20, 2015 | Ameditech Inc The Drug Detection Agency 6 Panel Cup Body and Lid w/Adult (AU),
Item No. TDDA-6MBAU-CUP
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug Terminated |
JXM | None listed |
| Oct 20, 2015 | Ameditech Inc THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU,
MTPA-8MBAU
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. Terminated |
JXM | None listed |
| Nov 3, 2011 | Ameditech Inc ProScreen PSCup-5M Waived, Catalog Number: PSCup-5M Waived
Product Usage: The ProScreen Drugs of Abuse Test Cup is a one-step immunoassay for the qualitative detection of multiple drugs in human uri Terminated |
DKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.