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
FDA 510(k) K200436 · Hologic, Inc.
Submission
- 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
- Applicant
- Hologic, Inc.
San Diego, CA, US - Received
- February 24, 2020
- Decision date
- March 23, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QEP – Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3393
- Specialty
- Microbiology
A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) in clinical specimens collected from patients suspected of sexually transmitted infections. The device is intended to aid in the diagnosis of non-viral sexually…
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| K243396 | Aptima SARS-CoV-2 AssayQQX · Traditional | 02/13/2025SE |
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Questions and answers
When was 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 cleared by the FDA?
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 (K200436) received a 510(k) decision of Substantially Equivalent on March 23, 2020, 28 days after the submission was received.
What is the product code of K200436?
The FDA product code is QEP – Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections, a Class II (moderate risk) device regulated under 21 CFR 866.3393.