AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
FDA 510(k) K152025 · Assure Tech. Co., Ltd.
510(k) numberK152025
Submission
- Device name
- AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
- Applicant
- Assure Tech. Co., Ltd.
Hangzhou, CN - Received
- July 22, 2015
- Decision date
- October 5, 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 |
| 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 |
| K092048 | One Step Eddp (Methadone Metabolite) Test StripDJR · Traditional | Biosite Incorporated | 04/19/2010SE |
More from Biosite Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K261984 | AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test CupNFT · Traditional | 07/17/2026SE |
| K260754 | Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen TestQYT · Traditional | 06/05/2026SE |
| K252259 | AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test CupNFT · Traditional | 08/15/2025SE |
| K250117 | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteLCX · Traditional | 02/13/2025SE |
| K243996 | AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test…NFT · Traditional | 02/07/2025SE |
| K243573 | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette…LCX · Traditional | 01/15/2025SE |
| K240351 | FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)NGL · Traditional | 03/06/2024SE |
| K152768 | Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy…JHI · Traditional | 02/24/2016SE |
| K151211 | AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech…DIS · Traditional | 06/04/2015SE |
Questions and answers
When was AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) cleared by the FDA?
AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) (K152025) received a 510(k) decision of Substantially Equivalent on October 5, 2015, 75 days after the submission was received.
What is the product code of K152025?
The FDA product code is DJR – Enzyme Immunoassay, Methadone, a Class II (moderate risk) device regulated under 21 CFR 862.3620.