Device Information
The Aptima Neisseria gonorrhoeae Assay detects Neisseria gonorrhoeae ribosomal RNA (rRNA). It uses a combination of target capture, transcription-mediated amplification (TMA), and hybridization protection assay (HPA) technologies. The assay operates on the Panther system, which automates the process. It tests male urine specimens and reports results using relative light units (RLU). The system is fully automated, making it efficient for clinical labs.
Indications for Use
The Aptima Neisseria gonorrhoeae Assay is an in vitro qualitative nucleic acid amplification test for detecting rRNA from Neisseria gonorrhoeae in male urine samples. It aids in diagnosing gonococcal urogenital disease and can be used for symptomatic and asymptomatic patients.
Intended Use and Users
The assay is intended to detect gonococcal infections in male patients, whether symptomatic or asymptomatic. It is for prescription use only and can be used in clinical settings, including sexually transmitted infection (STI) clinics.
Availability
This device is prescription-only.
Study Results
- Clinical Testing: A multi-center study evaluated 1958 male urine specimens. The sensitivity was 98.4% and specificity was 99.9%. The assay performed well across both symptomatic and asymptomatic groups.
- Nonclinical and Safety Testing: The limit of detection (LoD) was 0.04933 CFU/mL for antibiotic-sensitive strains and 0.03986 CFU/mL for antibiotic-resistant strains. Interference testing showed no interference from substances like blood, contraceptive jelly, or medications.
Regulatory Information
- Regulation Number: 21 CFR 866.3390
- Regulatory Class: Class II
- Product Code: LSL
- Additional Regulations: The device complies with quality system regulations (21 CFR Part 820) and follows good manufacturing practices.
Manufacturer Information
- Name: Hologic, Inc.
- Address: 10210 Genetic Center Drive, San Diego, CA 92121
- Contact Person: Jon Kukowski
Predicate Device Information
- Predicate Device Name: GEN-PROBE Aptima Neisseria gonorrhoeae Assay (Tigris DTS platform)
- Predicate 510(k) Number: K063664
- Differences: The current assay is automated on the Panther system, designed for male urine specimens only, unlike the previous version, which was for male and female specimens across multiple platforms.
Implications
The assay offers efficient, automated detection of Neisseria gonorrhoeae, potentially improving STI diagnosis accuracy in clinical settings. Its ease of use may increase its utility for high-throughput labs.
Medevx References
- Aptima Neisseria gonorrhoeae Assay. K231329. FDA summary link: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K231329
- https://www.hologic.com/hologic-products/gynecologic-health/aptima-sexual-and-vaginal-health-solutions
- https://www.hologic.com/hologic-products/diagnostic-solutions/panther-system
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