K243396 is an FDA 510(k) clearance for the Aptima SARS-CoV-2 Assay. This device is classified as a Respiratory Specimen Nucleic Acid Sars-cov-2 Test (Class II - Special Controls, product code QQX).
Submitted by Hologic, Inc. (San Diego, US). The FDA issued a Cleared decision on February 13, 2025, 105 days after receiving the submission on October 31, 2024.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3981. A Device To Detect And Identify Nucleic Acid Targets In Respiratory Specimens From Sars-cov-2 That Cause Covid-19 Is An In Vitro Diagnostic Device Intended For The Detection And Identification Of Sars-cov-2 Nucleic Acid Targets In Human Clinical Respiratory Specimens From Patients Suspected Of Covid-19 Based On Signs And Symptoms Of Respiratory Infections By Their Healthcare Providers. The Device Is Intended To Aid In The Diagnosis Of Covid-19 In Conjunction With Other Clinical, Epidemiologic, And Laboratory Data Or Other Risk Factors..
| 510(k) Number | K243396 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2024 |
| Decision Date | February 13, 2025 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | QQX — Respiratory Specimen Nucleic Acid Sars-cov-2 Test |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3981 |
| Definition | A Device To Detect And Identify Nucleic Acid Targets In Respiratory Specimens From Sars-cov-2 That Cause Covid-19 Is An In Vitro Diagnostic Device Intended For The Detection And Identification Of Sars-cov-2 Nucleic Acid Targets In Human Clinical Respiratory Specimens From Patients Suspected Of Covid-19 Based On Signs And Symptoms Of Respiratory Infections By Their Healthcare Providers. The Device Is Intended To Aid In The Diagnosis Of Covid-19 In Conjunction With Other Clinical, Epidemiologic, And Laboratory Data Or Other Risk Factors. |