First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test
FDA 510(k) K151441 · W.H.P.M., Inc.
510(k) numberK151441
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
- May 29, 2015
- Decision date
- June 29, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DJR – Enzyme Immunoassay, Methadone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3620
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DJR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192433 | LZI Methadone II Enzyme ImmunoassayDJR · Traditional | Lin-Zhi International, Inc. | 10/04/2019SE |
| K182779 | ARK EDDP AssayDJR · Traditional | Ark Diagnostics, Inc. | 11/21/2018SE |
| K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300)…DJR · Traditional | Lin-Zhi International, Inc. | 06/26/2017SE |
| K160793 | First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of…DJR · Traditional | W.H.P.M., Inc. | 08/17/2016SE |
| K152025 | AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)…DJR · Traditional | Assure Tech. Co., Ltd. | 10/05/2015SE |
| K151395 | Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators…DJR · Traditional | Immunalysis Corporation | 07/24/2015SE |
| K131232 | Wondfo Methadone Urine Test (MTD 200), Wondofo Morphine Urine Test (Mop 100)DJR · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 05/31/2013SE |
| K092272 | Randox Methadone AssayDJR · Traditional | Randox Laboratories, Ltd. | 11/18/2010SE |
| K092258 | Randox Metabolite (Eddp) AssayDJR · Traditional | Randox Laboratories, Ltd. | 11/09/2010SE |
| K092048 | One Step Eddp (Methadone Metabolite) Test StripDJR · Traditional | Biosite Incorporated | 04/19/2010SE |
More from Biosite Incorporated
| 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 |
| K150162 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestLAF · Traditional | 02/26/2015SE |
| K142353 | First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup TestDIO · Traditional | 10/07/2014SE |
| 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 (K151441) received a 510(k) decision of Substantially Equivalent on June 29, 2015, 31 days after the submission was received.
What is the product code of K151441?
The FDA product code is DJR – Enzyme Immunoassay, Methadone, a Class II (moderate risk) device regulated under 21 CFR 862.3620.