First Sign Drug of Abuse Urine Screening Test
FDA 510(k) K052197 · W.H.P.M., Inc.
510(k) numberK052197
Submission
- Device name
- First Sign Drug of Abuse Urine Screening Test
- Applicant
- W.H.P.M., Inc.
Beverly, MA, US - Received
- August 12, 2005
- Decision date
- June 9, 2006
- 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 |
| K151441 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestDJR · Traditional | W.H.P.M., Inc. | 06/29/2015SE |
| 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 |
More from Randox Laboratories, 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 |
| K142353 | First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup TestDIO · Traditional | 10/07/2014SE |
| 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 Urine Screening Test cleared by the FDA?
First Sign Drug of Abuse Urine Screening Test (K052197) received a 510(k) decision of Substantially Equivalent on June 9, 2006, 301 days after the submission was received.
What is the product code of K052197?
The FDA product code is DJR – Enzyme Immunoassay, Methadone, a Class II (moderate risk) device regulated under 21 CFR 862.3620.