First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test
FDA 510(k) K150162 · W.H.P.M., Inc.
510(k) numberK150162
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
- January 26, 2015
- Decision date
- February 26, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LAF – Gas Chromatography, Methamphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3610
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LAF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203647 | SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayLAF · Traditional | Immunalysis Corporation | 12/22/2021SE |
| K210212 | Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairLAF · Traditional | Psychemedics Corporation | 12/15/2021SE |
| K201442 | Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus AnalyzersLAF · Traditional | Diatron Group | 07/31/2020SE |
| K170222 | Rapid Tox Cup IILAF · Traditional | American Bio Medica Corp. | 08/15/2017SE |
| K153693 | Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsLAF · Traditional | Immunalysis Corporation | 03/18/2016SE |
| K142293 | Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine…LAF · Traditional | Biophor Diagnostics, Inc. | 09/18/2015SE |
| K150096 | Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test…LAF · Traditional | Healgen Scientific,, LLC | 03/04/2015SE |
| K133047 | Rapidfret Oral Fluid Assay for Mdma, Rapidfret Oral Fluid Calibrators, Rapidfret Oral…LAF · Traditional | Biophor Diagnostics, Inc. | 12/18/2014SE |
| K131652 | Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, ControlsLAF · Traditional | Lin-Zhi International, Inc. | 03/21/2014SE |
| K111927 | Psychemedics Methamphetamine EiaLAF · Traditional | Psychemedics Corp. | 05/01/2012SE |
More from Psychemedics Corp.
| 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 |
| 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 (K150162) received a 510(k) decision of Substantially Equivalent on February 26, 2015, 31 days after the submission was received.
What is the product code of K150162?
The FDA product code is LAF – Gas Chromatography, Methamphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3610.