DEN160025 is an FDA 510(k) submission for the ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit. This device is classified as a Fish (fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp. (Class II - Special Controls, product code PYN).
Submitted by Id-Fish Technology, Inc. (Palo Alto, US). The FDA issued a Not Cleared (DENG) decision on August 18, 2017.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3367. The Plasmodium Sp. Fish Is Intended To Detect Plasmodium Spp. Parasites And/or Differentiate Parasite Species In Clinical Whole Blood Smear Specimens From Patients With Signs Or Symptoms Of Malaria And Suspicion Of Infection..
| 510(k) Number | DEN160025 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | June 27, 2016 |
| Decision Date | August 18, 2017 |
| Days to Decision | 417 days |
| Submission Type | Direct |
| Review Panel | Microbiology (MI) |
| Summary | - |
| Product Code | PYN - Fish (fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3367 |
| Definition | The Plasmodium Sp. Fish Is Intended To Detect Plasmodium Spp. Parasites And/or Differentiate Parasite Species In Clinical Whole Blood Smear Specimens From Patients With Signs Or Symptoms Of Malaria And Suspicion Of Infection. |