LZI Fentanyl Enzyme Immunoassay
FDA 510(k) K181159 · Lin-Zhi International, Inc.
510(k) numberK181159
Submission
- Device name
- LZI Fentanyl Enzyme Immunoassay
- Applicant
- Lin-Zhi International, Inc.
Santa Clara, CA, US - Received
- May 1, 2018
- Decision date
- December 3, 2018
- 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 |
| 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 |
|---|---|---|
| K253082 | LZI Buprenorphine II Enzyme ImmunoassayDJG · Traditional | 01/16/2026SE |
| K251634 | LZI Fentanyl III Enzyme ImmunoassayDJG · Special | 06/18/2025SE |
| K202007 | LZI Oxycodone III Enzyme ImmunoassayDJG · Traditional | 09/17/2020SE |
| K201938 | LZI Fentanyl II Enzyme ImmunoassayDJG · Traditional | 08/07/2020SE |
| K201223 | LZI Tramadol Enzyme ImmunoassayDJG · Traditional | 06/04/2020SE |
| K192299 | LZI Cotinine II Enzyme ImmunoassayMKU · Traditional | 11/21/2019SE |
| K192433 | LZI Methadone II Enzyme ImmunoassayDJR · Traditional | 10/04/2019SE |
| K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300)…DJR · Traditional | 06/26/2017SE |
| K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators…LDJ · Traditional | 05/28/2015SE |
| K141205 | Lzi Oral Fluid 6-ACETYLMORPHINE Enzyme Immunoassay, Lzi Oral Fluid 6-ACETYLMORPHINE…DJG · Traditional | 02/13/2015SE |
Questions and answers
When was LZI Fentanyl Enzyme Immunoassay cleared by the FDA?
LZI Fentanyl Enzyme Immunoassay (K181159) received a 510(k) decision of Substantially Equivalent on December 3, 2018, 216 days after the submission was received.
What is the product code of K181159?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.