The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Aptima Combo 2 Assay (250 Test Kit) Panther, Aptima Combo 2 Assay (250 Test Kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 Test Kit) Panther, Aptima Trichomonas Vaginalis Assay (250 Test Kit) Tigris.
| Device ID | K220321 |
| 510k Number | K220321 |
| Device Name: | Aptima Combo 2 Assay (250 Test Kit) Panther, Aptima Combo 2 Assay (250 Test Kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 Test Kit) Panther, Aptima Trichomonas Vaginalis Assay (250 Test Kit) Tigris |
| Classification | Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections |
| Applicant | Hologic, Inc. 10210 Genetic Center Drive San Diego, CA 92121 |
| Contact | Jill Wyland |
| Correspondent | Jill Wyland Hologic, Inc. 10210 Genetic Center Drive San Diego, CA 92121 |
| Product Code | QEP |
| Subsequent Product Code | LSL |
| Subsequent Product Code | MKZ |
| Subsequent Product Code | OUY |
| CFR Regulation Number | 866.3393 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-03 |
| Decision Date | 2022-06-03 |