First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test
FDA 510(k) K142353 · W.H.P.M., Inc.
510(k) numberK142353
Submission
- Device name
- First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test
- Applicant
- W.H.P.M., Inc.
Irwindale, CA, US - Received
- August 21, 2014
- Decision date
- October 7, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DIO – Enzyme Immunoassay, Cocaine And Cocaine Metabolites
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3250
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DIO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213211 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM)…DIO · Traditional | Carolina Liquid Chemistries Corp. | 01/27/2022SE |
| K211973 | DRI Cocaine Metabolite AssayDIO · Traditional | Microgenics Corporation | 09/24/2021SE |
| K191638 | Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayDIO · Traditional | Medtest DX | 03/12/2020SE |
| K181499 | DRI Cocaine Metabolite AssayDIO · Traditional | Microgenics Corporation | 07/06/2018SE |
| K170293 | Emit II Plus Cocaine Metabolite AssayDIO · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/25/2017SE |
| K163570 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)DIO · Traditional | Carolina Liquid Chemistries Corporation | 08/15/2017SE |
| K162395 | MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test CupDIO · Special | Mp Biomedicals, LLC | 06/02/2017SE |
| K152232 | Quest Diagnostics HairCheck-DT (Cocaine)DIO · Traditional | Quest Diagnostics Incorporated | 11/18/2016SE |
| K161214 | Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC…DIO · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 06/27/2016SE |
| K153646 | SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test…DIO · Traditional | Safecare Biotech (Hangzhou) Co., Ltd. | 03/18/2016SE |
More from Safecare Biotech (Hangzhou) Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K200754 | Hemosure Accu-Reader A100OOX · Traditional | 06/02/2022SE |
| K210327 | First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign…QBF · Traditional | 08/12/2021SE |
| K171695 | First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of…NFT · Traditional | 02/05/2018SE |
| K160793 | First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of…DJR · Traditional | 08/17/2016SE |
| K152551 | First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse…DJG · Traditional | 11/09/2015SE |
| K151441 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestDJR · Traditional | 06/29/2015SE |
| K150162 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestLAF · Traditional | 02/26/2015SE |
| K052197 | First Sign Drug of Abuse Urine Screening TestDJR · Traditional | 06/09/2006SE |
| K051841 | WH Accu Test One-Step Urine/Serum Combo Pregnancy TestJHI · Traditional | 08/22/2005SE |
| K041202 | Hemosure One-Step Fecal Occult Blood TestKHE · Traditional | 08/12/2004SE |
Questions and answers
When was First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test cleared by the FDA?
First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test (K142353) received a 510(k) decision of Substantially Equivalent on October 7, 2014, 47 days after the submission was received.
What is the product code of K142353?
The FDA product code is DIO – Enzyme Immunoassay, Cocaine And Cocaine Metabolites, a Class II (moderate risk) device regulated under 21 CFR 862.3250.