BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader
FDA 510(k) K240124 · Vivachek Biotech (Hangzhou) Co., Ltd.
510(k) numberK240124
Submission
- Device name
- BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader
- Applicant
- Vivachek Biotech (Hangzhou) Co., Ltd.
Hangzhou, CN - Received
- January 16, 2024
- Decision date
- June 14, 2024
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K232597 | LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette)…DJG · Traditional | Hangzhou Laihe Biotech Co., Ltd. | 01/09/2024SE |
More from Hangzhou Laihe Biotech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261280 | BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test PanelNFT · Traditional | 05/22/2026SE |
| K252554 | Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test CupNFT · Traditional | 09/12/2025SE |
| K241869 | BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve…NGL · Traditional | 10/04/2024SE |
| K222126 | VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose…NBW · Traditional | 08/16/2024SE |
| K233058 | VivaChek Link Plus Blood Glucose Monitoring SystemNBW · Traditional | 12/22/2023SE |
| K233062 | BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel RxNFT · Traditional | 11/02/2023SE |
| K231978 | BioSieve Marijuana Test Panel 50; BioSieve Marijuana Test Strip 50; BioSieve Dx…NFW · Traditional | 08/31/2023SE |
| K222667 | Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup RxNFT · Traditional | 11/10/2022SE |
| K192957 | VivaChek Blood Glucose and B-Ketone Monitoring SystemJIN · Traditional | 06/05/2020SE |
Questions and answers
When was BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader cleared by the FDA?
BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader (K240124) received a 510(k) decision of Substantially Equivalent on June 14, 2024, 150 days after the submission was received.
What is the product code of K240124?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.