Atlas FDA

Aptima Trichomonas vaginalis Assay

FDA 510(k) clearance K231316 · decided 2023-11-06

Clearance details

K-number
K231316
Device name
Aptima Trichomonas vaginalis Assay
Applicant
Hologic, Inc.
Decision
Substantially Equivalent
Date received
2023-05-08
Decision date
2023-11-06
Days to decision
182 days
Clearance type
Traditional
Product code
OUY
Device class
2
Regulation number
866.3860
Medical specialty
Immunology
Advisory committee
Immunology
Location
San Diego, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
BD MAX CTGCTV2, BD MAX System (K182692)Becton, Dickinson and Company2019-01-08
BD MAX CT/GC/TV, BD MAX INSTRUMENT (K151589)Becton, Dickinson and Company2016-09-06
Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems (K161619)Cepheid2016-08-29
Solana Trichomonas Assay (K161182)Quidel Corporation2016-08-15
Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit (K151565)Cepheid2015-10-16
AmpliVue Trichomonas Assay (K143329)Quidel Corporation2015-03-17
BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY (K130268)Becton, Dickinson & CO2013-08-23
APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER (K122062)Gen-Probe, Inc.2013-01-09
APTIMA TRICHOMONAS VAGINALIS ASSAY (DEN110012)Gen-Probe Incorporated2011-04-19

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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ThinPrep Processor and ThinPrep Imaging System (P950039/S041)Hologic, Inc.2025-08-27
Rapid fFN Cassette Kit for the TLiIQ System, Rapid fFN Control for the TLiIQ System (P920048/S027)Hologic, Inc.2024-12-06
TLiIQ QCette (P920048/S026)Hologic, Inc.2024-10-23
Aptima CMV Quant Assay (P210029/S002)Hologic, Inc.2024-10-23
Aptima HBV Quant Assay (P170025/S022)Hologic, Inc.2024-10-23