Home / 510(k) Clearances / K200436

510(k) K200436

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 by Hologic, Inc. — Product Code QEP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2020
Date Received
February 24, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Device Class
Class II
Regulation Number
866.3393
Review Panel
MI
Submission Type

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 transmitted infections in conjunction with other clinical and laboratory data.

Other clearances by Hologic, Inc.

  • K251993 — Panther Fusion GI Expanded Bacterial Assay (September 25, 2025)
  • K251868 — Panther Fusion GI Bacterial Assay (September 25, 2025)
  • K243341 — Genius AI Detection 2.0 (July 31, 2025)
  • K243396 — Aptima SARS-CoV-2 Assay (February 13, 2025)
  • K243935 — Aptima CMV Quant Assay (January 17, 2025)
  • K243345 — Aptima BV Assay; Aptima CV/TV Assay (November 25, 2024)
  • K242465 — Panther Fusion SARS-CoV-2/Flu A/B/RSV assay (November 15, 2024)
  • K240886 — Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System (July 25, 2024)
  • K233352 — Aptima HCV Quant Dx Assay (July 24, 2024)
  • K241240 — Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay (July 18, 2024)

Other clearances for product code QEP

  • K251501 — Visby Medical Men's Sexual Health Test (October 1, 2025)
  • K243343 — BD CTGCTV2 (April 22, 2025)
  • K240217 — cobas® liat CT/NG nucleic acid test (January 17, 2025)
  • K240197 — cobas® liat CT/NG/MG nucleic acid test (January 16, 2025)
  • K230267 — NeuMoDx CT/NG Assay 2.0 (December 22, 2023)
  • K220407 — Visby Medical Sexual Health Test (March 7, 2023)
  • K222379 — Alinity m STI Assay (March 3, 2023)
  • K220321 — Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) (June 3, 2022)
  • K210585 — BD CTGCTV2 (May 10, 2022)
  • K202977 — Alinity m STI Assay (April 29, 2022)