Aptima BV Assay; Aptima CV/TV Assay

K243345 · Hologic, Inc. · PQA · Nov 25, 2024 · Microbiology

Device Facts

• Record ID: K243345
• Device Name: Aptima BV Assay; Aptima CV/TV Assay
• Applicant: Hologic, Inc.
• Product Code: PQA · Microbiology
• Decision Date: Nov 25, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3975
• Device Class: Class 2

Indications for Use

The Aptima BV Assay is an in vitro nucleic acid amplification test that utilizes real time Transcription-Mediated Amplification (TMA) technology for detection and quantitation of ribosomal RNA from bacteria associated with bacterial vaginosis (BV), including Lactobacillus (L. gasseri, L. crispatus, and L. jensenii), Gardnerella vaginalis (G. vaginalis), and Atopobium vaginae (A. vaginae). The assay reports a qualitative result for BV and does not report results for individual organisms. The assay is intended to aid in the diagnosis of BV on the automated Panther System using clinician-collected and patient-collected vaginal swab specimens from females with a clinical presentation consistent with vaginitis and/or vaginosis. The Aptima CV/TV Assay is an in vitro nucleic acid amplification test for the detection of RNA from microorganisms associated with vulvovaginal candidiasis and trichomoniasis. The assay utilizes real time Transcription-Mediated Amplification (TMA) technology to detect and qualitatively report results for the following organisms: Candida species group (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis), Candida glabrata (C. glabrata), and Trichomonas vaginalis (TV). The assay differentiates between C. glabrata and the Candida species group (C spp) by targeting the RNA component of RNAse P ribonucleoprotein; the assay does not differentiate among C spp. For TV, the assay targets ribosomal RNA (rRNA) and differentiates the result from results for C. glabrata and C spp. The assay is intended to aid in the diagnosis of vulvovaginal candidiasis and trichomoniasis on the automated Panther System using clinician-collected and patient-collected vaginal swab specimens from females with a clinical presentation consistent with vaginitis or vulvovaginitis.

Device Story

Aptima BV and CV/TV assays are in vitro nucleic acid amplification tests (NAAT) for vaginal swab specimens. Performed on the automated Panther System; process includes target capture, Transcription-Mediated Amplification (TMA), and real-time detection via fluorescent torches. Internal controls monitor capture, amplification, and detection. Panther system software interprets signal emergence times to provide qualitative results for BV, Candida species, C. glabrata, and T. vaginalis. Used in clinical settings to aid diagnosis of vaginitis/vaginosis/trichomoniasis. Benefits include automated, standardized diagnostic results for symptomatic patients.

Clinical Evidence

No clinical data provided; substantial equivalence supported by design control activities, risk analysis, and verification of the modified kit configuration.

Technological Characteristics

Real-time Transcription-Mediated Amplification (TMA) using MMLV reverse transcriptase and T7 RNA polymerase. Detection via fluorescent-labeled torches (fluorophore/quencher). Automated on Panther System. Analyte: ribosomal RNA (BV, TV) and RNAse P ribonucleoprotein (Candida). Kit configuration: 250 tests.

Indications for Use

Indicated for the detection of nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis.

Regulatory Classification

Identification

A device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis is a qualitative in vitro diagnostic device intended for the detection of microbial nucleic acid sequences in vaginal specimens collected from patients with signs and symptoms of vaginitis or bacterial vaginosis. This device is intended to aid in the diagnosis of vaginitis or bacterial vaginosis when used in conjunction with clinical signs and symptoms and other laboratory findings.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include: (i) Documentation with a detailed device description of device components; ancillary reagents required but not provided; and explanation of the methodology including primer/probe sequence, design, and rationale for sequence selection. (ii) Documentation with information that demonstrates the performance characteristics of the device, including: (A) Limit of Detection; (B) Precision (reproductivity); (C) Analytical specificity; (D) Analytical reactivity (inclusivity); (E) Specimen stability; and (F) Effects of interfering substances. (iii) Detailed documentation from a prospective clinical study. As appropriate to the intended use, the prospective clinical study must be performed on an appropriate study population, including women of various ages and ethnicities. The prospective clinical study must compare the device performance to results obtained from well-accepted comparator methods. (iv) Detailed documentation for device software, including software applications and hardware-based devices that incorporate software. (2) The labeling required under § 809.10(b) of this chapter must include: (i) A detailed explanation of the interpretation of results and acceptance criteria; (ii) For devices with an intended use that includes detection of nucleic acid sequences from bacteria associated with bacterial vaginosis, clinical performance stratified by patient demographics such as race, ethnicity, age, and pregnancy status. (iii) For devices with an intended use that includes detection of nucleic acid sequences from bacteria associated with bacterial vaginosis, a summary of device results in an asymptomatic population with demographic characteristics appropriate to the intended use population. (iv) For devices with an intended use that includes detection of either Candida species or bacteria associated with bacterial vaginosis, a limitation that *Candida* species and bacterial compositions associated with bacterial vaginosis can be present as part of normal vaginal flora and results should be considered in conjunction with available clinical information.

Predicate Devices

• Aptima BV Assay (K243345)
• Aptima CV/TV Assay (K243345)

Submission Summary (Full Text)

{0}

FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K243345

B Applicant

Hologic, Inc.

C Proprietary and Established Names

Aptima BV Assay; Aptima CV/TV Assay

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| PQA | Class II | 21 CFR 866.3975 - Device That Detects Nucleic Acid Sequences From Microorganisms Associated With Vaginitis And Bacterial Vaginosis | MI - Microbiology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own Class II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the submitter's previously cleared device.
2. Submitter's statement that the indications for use/intended use of the modified device as described in its labeling has not changed along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device modifications, including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the fundamental scientific technology of the modified device has not changed. This change

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

{1}

was for the addition of 250 test kit configurations to the currently marketed configurations of both the Aptima BV assay (100 test kit) and Aptima CV/TV assay (100 test kit).

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.

K243345 - Page 2 of 2