DRI Cocaine Metabolite Assay
FDA 510(k) K181499 · Microgenics Corporation
510(k) numberK181499
Submission
- Device name
- DRI Cocaine Metabolite Assay
- Applicant
- Microgenics Corporation
Fremont, CA, US - Received
- June 7, 2018
- Decision date
- July 6, 2018
- 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 |
| 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 |
| K142129 | Rapidfret Oral Fluid Assay for Cocaine, Rapidfret Oral Fluid Cocaine Calibrator Set…DIO · Traditional | Biophor Diagnostics, Inc. | 07/24/2015SE |
More from Biophor Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K243498 | Alinity c Benzodiazepines Reagent KitJXM · Special | 12/11/2024SE |
| K240670 | DRI Ecstasy Plus AssayDKZ · Special | 10/30/2024SE |
| K231020 | Alinity c Tricyclic Antidepressants Reagent KitLFH · Traditional | 11/17/2023SE |
| K231007 | CEDIA Heroin Metabolite (6-AM) AssayDJG · Traditional | 09/27/2023SE |
| K213875 | DRI TM Tricyclics Serum Tox AssayLFH · Traditional | 12/21/2022SE |
| K211973 | DRI Cocaine Metabolite AssayDIO · Traditional | 09/24/2021SE |
| K192943 | CEDIA Heroin Metabolite (6-AM) assayDJG · Traditional | 12/16/2019SE |
| K190968 | CEDIA Benzodiazepine AssayJXM · Traditional | 12/09/2019SE |
| K173963 | DRI Benzodiazepine AssayJXM · Traditional | 02/21/2018SE |
| K173195 | DRI Hydrocodone AssayDJG · Traditional | 02/13/2018SE |
Questions and answers
When was DRI Cocaine Metabolite Assay cleared by the FDA?
DRI Cocaine Metabolite Assay (K181499) received a 510(k) decision of Substantially Equivalent on July 6, 2018, 29 days after the submission was received.
What is the product code of K181499?
The FDA product code is DIO – Enzyme Immunoassay, Cocaine And Cocaine Metabolites, a Class II (moderate risk) device regulated under 21 CFR 862.3250.