Aptima®
Aptima SARS-CoV-2 Assay is a laboratory molecular test that qualitatively detects SARS-CoV-2 RNA in nasopharyngeal and anterior nasal swab specimens. The assay uses transcription-mediated…
Aptima SARS-CoV-2 Assay is a laboratory molecular test that qualitatively detects SARS-CoV-2 RNA in nasopharyngeal and anterior nasal swab specimens. The assay uses transcription-mediated amplification to make target RNA detectable, and the Panther or Panther Fusion system reports whether the target is detected.
The listed package, catalog ASY-17190, is box 2 of a 100-test assay presentation. It is a reagent package used with the Panther platform, rather than a standalone analyzer or a patient-facing test device.
Listed Item
Aptima® SARS-CoV-2 Assay, 100 test, box 2 of 2 (15°C to 30°C box).
Assay and Platform
The assay process includes target capture, amplification and signal detection. Captured RNA is amplified, then the system measures a light signal and compares it with a cutoff to produce a qualitative result.
The FDA review specifies Panther and Panther Fusion systems for the assay. The product works as part of that laboratory platform, which also handles sample processing and result reporting.
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
Record
| Listed by | Hologic, Inc., United States |
|---|---|
| FDA product code | QQX |
| Device type | Respiratory Specimen Nucleic Acid Sars-Cov-2 Test |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3981 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K243396 |
| Record published | 2025-03-14 |
| Record revised | 2025-04-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SARS-COV-2 ASSAY CONTROLS, APTIMA, IVD | In distribution | |
| BOX 2 ROOM TEMP, SARS-COV-2 ASSAY, APTIMA 100T IVD | In distribution | |
| BOX 1, REFRIG, SARS-COV-2 ASSAY, APTIMA 100T, IVD | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution Buffer | Life Technologies Corporation | 3 |
| COVID-19 Coronavirus Real Time PCR Kit | Jiangsu Bioperfectus Technologies Co., Ltd. | 2 |
| BioFire® COVID-19 Test 2 | BioFire Defense, LLC | 2 |
| cobas® SARS-CoV-2 Qualitative 480T | Roche Molecular Systems, Inc. | 1 |
| Simplexa COVID-19 Positive Control GEN II Pack | DiaSorin Molecular LLC | 1 |
| GeneXpert® | Cepheid | 1 |
| BD Respiratory Viral Panel-SCV2 for BD MAX™ System | Becton, Dickinson AND Company | 1 |
| cobas® SARS-CoV-2 Qualitative Control Kit | Roche Molecular Systems, Inc. | 1 |
| Simplexa COVID-19 Positive Control Pack | DiaSorin Molecular LLC | 1 |
| Simplexa COVID-19 Direct | DiaSorin Molecular LLC | 1 |
| cobas® SARS-CoV-2 Qualitative 192T | Roche Molecular Systems, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243396 | 2025-02-13 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.