FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
K Number: K242465
·
Decision Nov 15, 2024
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
32
Applicant Total
116
Review Days
87
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Basic Information
- Device Name
- Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
- K Number
- K242465
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3981
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hologic, Inc.
- Date Received
- August 20, 2024
- Decision Date
- November 15, 2024
- Product Code
- QOF
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | FDA class 2 | Microbiology |
Similar 510(k) Clearances
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Other Clearances by Hologic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253634 | CoolSeal Generator® (CSL-200-90) | Jun 17, 2026 | Substantially Equivalent |
| K251993 | Panther Fusion GI Expanded Bacterial Assay | Sep 25, 2025 | Substantially Equivalent |
| K243341 | Genius AI Detection 2.0 | Jul 31, 2025 | Substantially Equivalent |
| K243396 | Aptima SARS-CoV-2 Assay | Feb 13, 2025 | Substantially Equivalent |
| K243935 | Aptima CMV Quant Assay | Jan 17, 2025 | Substantially Equivalent |
| K243345 | Aptima BV Assay; Aptima CV/TV Assay | Nov 25, 2024 | Substantially Equivalent |
| K240886 | Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205) | Jul 25, 2024 | Substantially Equivalent |
| K233352 | Aptima HCV Quant Dx Assay | Jul 24, 2024 | Substantially Equivalent |
| K241240 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | Jul 18, 2024 | Substantially Equivalent |
| DEN210035 | Genius Digital Diagnostics System with the Genius Cervical AI algorithm | Jan 31, 2024 | Unknown |