FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit
K Number: K200436
·
Decision Mar 23, 2020
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
22
Applicant Total
116
Review Days
28
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Basic Information
- Device Name
- Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit
- K Number
- K200436
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.3393
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hologic, Inc.
- Date Received
- February 24, 2020
- Decision Date
- March 23, 2020
- 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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| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| K242465 | Panther Fusion SARS-CoV-2/Flu A/B/RSV assay | Nov 15, 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 |