Instant-View Cocaine (Benzylecgonine) Urine Cassette Test
FDA 510(k) K994398 · Alfa Scientific Designs, Inc.
510(k) numberK994398
Submission
- Device name
- Instant-View Cocaine (Benzylecgonine) Urine Cassette Test
- Applicant
- Alfa Scientific Designs, Inc.
San Diego, CA, US - Received
- December 28, 1999
- Decision date
- July 27, 2000
- 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 |
|---|---|---|
| K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW…DKZ · Traditional | 02/23/2018SE |
| K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood TestKHE · Traditional | 02/15/2018SE |
| K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test…DKZ · Traditional | 06/24/2016SE |
| K131645 | Instant-View Multi-Drug of Abuse Urine Test (Cup, Panel Cassette)DKZ · Abbreviated | 10/07/2013SE |
| K100051 | Instant-View Milti-Drug of Abuse Urine Test (Panel, Cup), Instant-Verdict Multi-Drug of…DJG · Abbreviated | 07/06/2010SE |
| K070660 | Instant-View Fecal Occult Blood (Fob) Rapid TestKHE · Traditional | 06/21/2007SE |
| K063545 | Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test(Cassette…DJG · Abbreviated | 05/07/2007SE |
| K060527 | Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test…DJG · Abbreviated | 07/25/2006SE |
| K042227 | Instant-View Troponin I TestMMI · Traditional | 11/19/2004SE |
| K024360 | Instant-View H. Pylori One Step Rapid TestLYR · Traditional | 06/10/2003SE |
Questions and answers
When was Instant-View Cocaine (Benzylecgonine) Urine Cassette Test cleared by the FDA?
Instant-View Cocaine (Benzylecgonine) Urine Cassette Test (K994398) received a 510(k) decision of Substantially Equivalent on July 27, 2000, 212 days after the submission was received.
What is the product code of K994398?
The FDA product code is DIO – Enzyme Immunoassay, Cocaine And Cocaine Metabolites, a Class II (moderate risk) device regulated under 21 CFR 862.3250.