FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Alinity m STI Assay
K Number: K222379
·
Decision Mar 3, 2023
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
22
Applicant Total
17
Review Days
210
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Basic Information
- Device Name
- Alinity m STI Assay
- K Number
- K222379
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3393
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Molecular, Inc.
- Date Received
- August 5, 2022
- Decision Date
- March 3, 2023
- Product Code
- QEP
- 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 |
|---|---|---|---|
| QEP | Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | FDA class 2 | Microbiology |
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Other Clearances by Abbott Molecular, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252102 | Alinity m HCV | Sep 25, 2025 | Substantially Equivalent |
| K243489 | Alinity m EBV (09N43-095) | Jul 28, 2025 | Substantially Equivalent |
| K243485 | Alinity m CMV | Jul 1, 2025 | Substantially Equivalent |
| K241921 | Alinity m BKV | Mar 24, 2025 | Substantially Equivalent |
| K241573 | Alinity m Resp-4-Plex | Feb 14, 2025 | Substantially Equivalent |
| K233349 | Alinity m HSV 1 & 2 / VZV | May 3, 2024 | Substantially Equivalent |
| K212778 | Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) | Jul 15, 2022 | Substantially Equivalent |
| K202977 | Alinity m STI Assay | Apr 29, 2022 | Substantially Equivalent |
| K140354 | ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG | May 9, 2014 | Substantially Equivalent |
| K131508 | VYSIS D7S486/CEP 7 FISH PROBE KIT | Sep 13, 2013 | Substantially Equivalent |