FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)
K Number: K252387
·
Decision Oct 30, 2025
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
32
Applicant Total
14
Review Days
91
Basic Information
- Device Name
- Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)
- K Number
- K252387
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3981
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diasorin Molecular, LLC
- Date Received
- July 31, 2025
- Decision Date
- October 30, 2025
- 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 |
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Other Clearances by Diasorin Molecular, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K260333 | LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit | Jun 15, 2026 | Substantially Equivalent |
| K251978 | LIAISON NES FLU A/B, RSV & COVID-19 | Dec 23, 2025 | Substantially Equivalent |
| DEN230092 | Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390) | Jul 15, 2024 | Unknown |
| K220963 | Simplexa COVID-19 & Flu A/B Direct | Mar 17, 2023 | Substantially Equivalent |
| K202755 | Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack | Nov 5, 2022 | Substantially Equivalent |
| K212147 | Simplexa COVID-19 Direct | Sep 13, 2022 | Substantially Equivalent |
| K201505 | Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack | Aug 22, 2020 | Substantially Equivalent |
| K192376 | Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack | Nov 26, 2019 | Substantially Equivalent |
| K190219 | Simplexa VZV Direct, Simplexa VZV Positive Control Pack | May 13, 2019 | Substantially Equivalent |
| K183223 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | Dec 19, 2018 | Substantially Equivalent |