Immunalysis Buprenorphine Urine Enzyme Immunoassay, Immunalysis Buprenorphine Urine Controls and Calibrators
FDA 510(k) K141406 · Immunalysis Corporation
510(k) numberK141406
Submission
- Device name
- Immunalysis Buprenorphine Urine Enzyme Immunoassay, Immunalysis Buprenorphine Urine Controls and Calibrators
- Applicant
- Immunalysis Corporation
Pomona, CA, US - Received
- May 28, 2014
- Decision date
- July 1, 2014
- 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 |
|---|---|---|
| K252520 | SEFRIA Hydrocodone Oral FluidDJG · Traditional | 09/11/2025SE |
| K232898 | Quantisal Oral Fluid Collection DevicePJD · Traditional | 11/21/2023SE |
| K223781 | Quantisal II Oral Fluid Collection DevicePJD · Traditional | 07/28/2023SE |
| K203647 | SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayLAF · Traditional | 12/22/2021SE |
| K203564 | SEFRIA Oxycodone Oral Fluid Enzyme ImmunoassayDJG · Traditional | 12/22/2021SE |
| K203489 | SEFRIA PCP Oral Fluid Enzyme ImmunoassayLCM · Traditional | 04/20/2021SE |
| K200801 | Quantisal Oral Fluid Collection DevicePJD · Traditional | 07/28/2020SE |
| K190397 | Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIAQBK · Traditional | 11/15/2019SE |
| K183048 | Quantisal II Oral Fluid Collection DevicePJD · Traditional | 07/29/2019SE |
| K181135 | Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayLCM · Traditional | 01/24/2019SE |
Questions and answers
When was Immunalysis Buprenorphine Urine Enzyme Immunoassay, Immunalysis Buprenorphine Urine Controls and Calibrators cleared by the FDA?
Immunalysis Buprenorphine Urine Enzyme Immunoassay, Immunalysis Buprenorphine Urine Controls and Calibrators (K141406) received a 510(k) decision of Substantially Equivalent on July 1, 2014, 34 days after the submission was received.
What is the product code of K141406?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.