Forsure One Step Buprenorphine Cup Test Device
FDA 510(k) K122064 · Tianjin New Bay Bioresearch Co., Ltd.
510(k) numberK122064
Submission
- Device name
- Forsure One Step Buprenorphine Cup Test Device
- Applicant
- Tianjin New Bay Bioresearch Co., Ltd.
San Diego, CA, US - Received
- July 13, 2012
- Decision date
- May 7, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DJG – Enzyme Immunoassay, Opiates
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3650
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DJG
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|---|---|---|---|
| K252684 | Labcorp Fentanyl Urine Visual TestDJG · Traditional | Medtox Diagnostics, Inc. | 01/29/2026SE |
| K250741 | Evidence MultiSTAT DOA Urine MultiPlexDJG · Traditional | Randox Laboratories Limited | 01/23/2026SE |
| K253082 | LZI Buprenorphine II Enzyme ImmunoassayDJG · Traditional | Lin-Zhi International, Inc. | 01/16/2026SE |
| K252520 | SEFRIA Hydrocodone Oral FluidDJG · Traditional | Immunalysis Corporation | 09/11/2025SE |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative…DJG · Traditional | Healgen Scientific,, LLC | 08/15/2025SE |
| K251634 | LZI Fentanyl III Enzyme ImmunoassayDJG · Special | Lin-Zhi International, Inc. | 06/18/2025SE |
| K240124 | BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA ReaderDJG · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 06/14/2024SE |
| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test DipcardDJG · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 05/10/2024SE |
| K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test DipcardDJG · Traditional | Co-Innovation Biotech Co., Ltd. | 03/08/2024SE |
| K232228 | Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine…DJG · Traditional | Shanghai Accurature Diagnostics Co., Ltd. | 02/23/2024SE |
More from Shanghai Accurature Diagnostics Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K130275 | Quikscreen Multi (Mdma and Opi) OTC Drug Cup TestDJG · Traditional | 09/26/2013SE |
| K112449 | Quikresponse One Step Midstream Early Pregrancy TestLCX · Traditional | 09/24/2012SE |
| K071489 | Homecheck Multiple Drug Cup TestDKZ · Traditional | 03/28/2008SE |
| K073431 | Forsure Ifob Duel Sample Fecal Occult Blood Test Device (for Professional and Home Use)…KHE · Special | 01/14/2008SE |
| K061617 | Forsure One Step Dip & Read (X) Drug Screen TestDKZ · Traditional | 11/22/2006SE |
| K052520 | Rapid Forsure One Step Multiple Drug (Up to 6) Screen Test Device for Amphetamine…DJG · Traditional | 04/24/2006SE |
| K052882 | Forsure Rapid One Step Multiple(X) Abuse Drug Screen Test Cup DeviceDKZ · Traditional | 02/15/2006SE |
| K052208 | Glucose PilotNBW · Traditional | 12/09/2005SE |
| K042988 | Rapid One Step Buprenorphine Test CardDJG · Traditional | 05/12/2005SE |
| K042990 | For Sure One Step Buprenorphine Test StripDJG · Traditional | 05/10/2005SE |
Questions and answers
When was Forsure One Step Buprenorphine Cup Test Device cleared by the FDA?
Forsure One Step Buprenorphine Cup Test Device (K122064) received a 510(k) decision of Substantially Equivalent on May 7, 2013, 298 days after the submission was received.
What is the product code of K122064?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.