K231536 is an FDA 510(k) clearance for the eQUANT System. This device is classified as a Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing (Class II - Special Controls, product code QZX).
Submitted by Avails Medical, Inc. (Menlo Park, US). The FDA issued a Cleared decision on February 8, 2024, 254 days after receiving the submission on May 30, 2023.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1650. Processing Device That Includes Associated Reagents, When Applicable, That Is Intended To Recover Microbes From Positive Blood Cultures For Inoculum Preparation. The Prepared Inoculum Is Intended For Subsequent Use In Antimicrobial Susceptibility Testing..
| 510(k) Number | K231536 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2023 |
| Decision Date | February 08, 2024 |
| Days to Decision | 254 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | QZX - Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1650 |
| Definition | Processing Device That Includes Associated Reagents, When Applicable, That Is Intended To Recover Microbes From Positive Blood Cultures For Inoculum Preparation. The Prepared Inoculum Is Intended For Subsequent Use In Antimicrobial Susceptibility Testing. |