# K151589: BD Max CT/GC/TV, BD Max Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Sep 6, 2016 after 452 days
- Product code: OUY (Trichomonas Vaginalis Nucleic Acid Amplification Test System)
- Device class: 2
- Regulation: 21 CFR 866.3860
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K984631 (1999). 6 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081824: BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay, Becton, Dickinson & CO (2008) Summary page 5.
- K081825: BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna Assay, Becton, Dickinson & CO (2008) Summary page 5.
- K130268: BD Probetec Trichomonas Vaginalis (TV) QX Amplified Dna Assay, Becton, Dickinson & CO (2013) Summary page 5.

## Most influential descendants
- K182692: BD MAX CTGCTV2, BD MAX System (2019), 3 descendants of its own
- K210585: BD CTGCTV2 (2022), 1 descendant of its own
- K202977: Alinity m STI Assay (2022), 1 descendant of its own
- K243343: BD CTGCTV2 (2025), 0 descendants of its own
- K222379: Alinity m STI Assay (2023), 0 descendants of its own

## Recalls of this device
- Jul 17, 2019 · Class II · Z-2331-2019: The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
- Jul 18, 2017 · Class II · Z-0394-2018: BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAXTM Vaginal Panel, experienced by some customers. A non-reporta

## Indications for use
The BD MAX CT/GC/TV assay, as performed using the BD MAX System incorporates automated DNA extraction and real-time polymerase chain reaction (PCR) for the direct, qualitative detection of DNA from Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC) and/or Trichomonas vaginalis (TV). The assay may be used for detection of CT and/or GC DNA in male urine specimens, and the detection of CT, GC and/or TV DNA in female urine specimens, clinician-collected female endocervical swab specimens and patient-collected vaginal swab specimens (in a clinical setting). The assay is indicated for use to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and/or trichomoniasis in asymptomatic and symptomatic individuals.

Source page: https://510kreport.com/device/K151589
Methodology: https://510kreport.com/methodology