BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY

K140448 · Becton, Dickinson & CO · LSL · May 20, 2014 · Microbiology

Device Facts

• Record ID: K140448
• Device Name: BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
• Applicant: Becton, Dickinson & CO
• Product Code: LSL · Microbiology
• Decision Date: May 20, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3390
• Device Class: Class 2

Intended Use

The BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay, when tested with either the BD Viper™ System in Extracted Mode or the BD Viper™ LT System, uses Strand Displacement Amplification technology for the direct, qualitative detection of Neisseria gonorrhoeae DNA in clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens (both UPT and Neat). The assay is also intended for use with gynecological specimens collected in BD SurePath™ Preservative Fluid or PreservCyt™ Solution using an aliquot that is removed prior to processing for either the BD SurePath or ThinPrep™ Pap test. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease.

Device Story

The BD ProbeTec GCQ Assay is a molecular diagnostic test for Neisseria gonorrhoeae. It utilizes Strand Displacement Amplification (SDA) technology to amplify and detect target DNA sequences. The assay uses dried reagents in disposable microwells: a Priming Microwell (primers, detector probe, nucleotides) and an Amplification Microwell (DNA polymerase, restriction endonuclease). The device is designed for use on the BD Viper LT System, a bench-top laboratory instrument that automates nucleic acid extraction, amplification, and detection. The system processes various specimen types, including swabs, urine, and liquid-based cytology (LBC) media. The instrument provides qualitative results to laboratory personnel, which are used by clinicians to aid in the diagnosis of gonococcal urogenital infections. The assay benefits patients by providing an automated, standardized method for detecting N. gonorrhoeae, facilitating timely clinical decision-making.

Clinical Evidence

Clinical performance was evaluated using 653 female and 170 male subjects across four clinical sites. Comparison panels of randomized positive and negative specimens were tested on the BD Viper LT System and compared to reference results from the BD Viper System (extracted mode). Total Positive Percent Agreement (PPA) was 98.4% (440/447) and Negative Percent Agreement (NPA) was 99.0% (1152/1164). Reproducibility was assessed across three sites over eight days, showing high concordance across specimen types.

Technological Characteristics

Uses Strand Displacement Amplification (SDA) with Bst DNA polymerase and BsoBI restriction enzyme. Reagents are provided in dried Priming and Amplification microwells. Detects GC pilin gene inverting protein homologue using a fluorescein-labeled detector probe with a Dabcyl quencher. Operates on the BD Viper LT System, a bench-top automated instrument. Qualitative NAAT assay.

Indications for Use

Indicated for the qualitative detection of Neisseria gonorrhoeae DNA in symptomatic and asymptomatic individuals to aid in the diagnosis of gonococcal urogenital disease. Applicable to males and females using clinician-collected endocervical/urethral swabs, patient-collected vaginal swabs, urine (neat/UPT), and gynecological specimens in SurePath or PreservCyt media.

Regulatory Classification

Identification

Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identify Neisseria spp. from cultured isolates. Additionally, some of these reagents consist of Neisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence of Neisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Neisseria, such as epidemic cerebrospinal meningitis, meningococcal disease, and gonorrhea, and also provides epidemiological information on diseases caused by these microorganisms. The device does not include products for the detection of gonorrhea in humans by indirect methods, such as detection of antibodies or of oxidase produced by gonococcal organisms.

Predicate Devices

• BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay (K081825)

Submission Summary (Full Text)

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K140448

# BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay on the BD Viper LT System

MAY 2 0 2014

| Applicant | BD Diagnostic Systems<br>7 Loveton Circle<br>Sparks, MD 21152 |
|--------------------------------|----------------------------------------------------------------------------------------------|
| Establishment Registration No. | 1119779 |
| Contact Person | Sherma Winston, M.S., RAC<br>tel. [phone]<br>fax. [phone]<br>[e-mail] |
| Summary Date | May 15, 2014 |
| Proprietary Name | BD ProbeTec™ Neisseria gonorrhoeae (GC) Q ^x Amplified<br>DNA Assay |
| Generic Name | DNA probe, nucleic acid amplification, Neisseria |
| Classification | Class II |
| Classification Name | Neisseria spp. direct serological test reagents |
| Regulation Number | 866.3390 |
| Product Code | LSL |

#### Predicate Device

The BD ProbeTec Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay (BD ProbeTec GCQ Assay) was cleared for use with the predicate BD Viper System in extracted mode via K081825.

#### Device Description

The BD ProbeTec GCO Assay is based on the simultaneous amplification and detection of target DNA using amplification primers and a fluorescently-labeled detector probe The reagents for strand displacement amplification (SDA) are dried in two separate disposable microwells: the Priming Microwell contains the amplification primers, fluorescently-labeled detector probe, nucleotides and other reagents necessary for amplification, while the Amplification Microwell contains the two enzymes (a DNA polymerase and a restriction endonuclease) that are required for SDA. In alignment with the FDA Guidance Document, "Assay Migration Studies for In Vitro Diagnostic Devices, Guidance for Industry and FDA Staff", April 25, 2013 the BD ProbeTec GCQ Assay is being migrated from the existing BD Viper System operating in extracted mode (Viper XTR) to the new BD Viper LT System.

The BD Viper LT System is a table-top instrument that is designed to be fully contained on a standard laboratory bench-top. The system performs automated extraction of nucleic acids from

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# BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay on the BD Viper LT System

multiple specimen types in addition to amplification and detection of target nucleic acid sequences when utilized with legally marketed in vitro diagnostic assays.

# Intended Use

The BD ProbeTec Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay, when tested with either the BD Viper™ System in Extracted Mode or the BD Viper™ LT System, uses Strand Displacement Amplification technology for the direct, qualitative detection of Neisseria gonorrhoeae DNA in clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens (both UPT and Neat). The assay is also intended for use with gynecological specimens collected in BD SurePath™ Preservative Fluid or PreservCyt™ Solution using an aliquot that is removed prior to processing for either the BD SurePath or ThinPrep™ Pap test. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease.

## Comparison to Predicate Device

A comparison of the BD ProbeTec GCQ Assay on the BD Viper LT System with the predicate BD Viper System is summarized below.

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Image /page/2/Picture/0 description: The image shows the BD logo. The logo consists of a stylized sun and human figure on the left, followed by the letters "BD" in bold, sans-serif font. Below the letters, there is a tagline that reads "Helping all people live healthy lives" in a smaller, sans-serif font.

# BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay on the BD Viper LT System

| Item | BD ProbeTec GCQ Assay on the<br>BD Viper System<br>(K081825) | BD ProbeTec GCQ Assay on the<br>BD Viper LT System<br>(K140448) |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Class | II | II |
| Regulation Specialty | Microbiology | Microbiology |
| Assay Results | Qualitative | Qualitative |
| Type of Assay | Molecular NAAT | Molecular NAAT |
| Intended Use | The BD ProbeTec (GC) Qx<br>Amplified DNA Assay, when tested<br>with the BD Viper™ System in<br>Extracted Mode, uses Strand<br>Displacement Amplification<br>technology for the direct, qualitative<br>detection of <i>Neisseria gonorrhoeae</i><br>DNA in clinician-collected female<br>endocervical and male urethral swab<br>specimens, patient-collected vaginal<br>swab specimens (in a clinical setting),<br>and male and female urine specimens.<br>The assay is indicated for use with<br>asymptomatic and symptomatic<br>individuals to aid in the diagnosis of<br>gonococcal urogenital disease. | The BD ProbeTec <i>Neisseria<br/>gonorrhoeae</i> (GC) Qx Amplified<br>DNA Assay, when tested with either<br>the BD Viper™ System in Extracted<br>Mode or the BD Viper™ LT System,<br>uses Strand Displacement<br>Amplification technology for the<br>direct, qualitative detection of<br><i>Neisseria gonorrhoeae</i> DNA in<br>clinician-collected female<br>endocervical and male urethral swab<br>specimens, patient-collected vaginal<br>swab specimens (in a clinical setting),<br>and male and female urine specimens<br>(both UPT and neat). The assay is also<br>intended for use with gynecological<br>specimens collected in BD<br>SurePath™ Preservative Fluid or<br>PreservCyt™ Solution using an<br>aliquot that is removed prior to<br>processing for either the BD SurePath<br>or ThinPrep™ Pap test. The assay is<br>indicated for use with asymptomatic<br>and symptomatic individuals to aid in<br>the diagnosis of gonococcal urogenital<br>disease. |
| Technology | Strand Displacement Amplification<br>(SDA) | same |
| Specimen Types | Female specimens:<br>endocervical swab<br>patient-collected vaginal swab<br>neat urine<br>UPT urine | Female specimens:<br>endocervical swab<br>patient-collected vaginal swab<br>neat urine<br>UPT urine<br>LBC specimens collected in SurePath<br>Preservative Fluid |
| Item | BD ProbeTec GCQ Assay on the<br>BD Viper System<br>(K081825) | BD ProbeTec GCQ Assay on the<br>BD Viper LT System<br>(K140448) |
| | Male specimens:<br>urethral swab<br>neat urine<br>UPT urine | LBC specimens collected in<br>PreservCyt Solution<br><br>Male specimens:<br>urethral swab<br>neat urine<br>UPT urine |
| Priming Microwell | | |
| Primers | Target a sequence within the GC pilin<br>gene inverting protein homologue | Same |
| Detector | Linear, analyte-specific Detector Probe<br>• Fluorescein (fluorophore)<br>• Dabcyl (quencher) | Same |
| Nucleotides | 4 nucleotides required for SDA | Same |
| Non-specific reagents and<br>cofactors | Buffering components, magnesium ions,<br>salt and stabilizing reagents | Same |
| Amplification Microwell | | |
| Restriction Enzyme | <i>Bso</i> BI restriction enzyme | Same |
| Polymerase | <i>Bst</i> DNA polymerase | Same |
| Non-specific reagents and<br>cofactors | Buffering components, magnesium ions,<br>salt and stabilizing reagents | Same |
| Assay Buffer | Bicine-potassium hydroxide-based | Same |

#### Table 1 Comparison to Predicate Device

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# BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay on the BD Viper LT System

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# BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay on the BD Viper LT System

### Analytical Performance Characteristics

The BD ProbeTec GCO Assay formulation for the BD Viper LT System has not changed from that used with the BD Viper System in extracted mode. Studies were conducted to support analytical performance of the BD Viper LT System.

#### System Contamination

A study was conducted to evaluate the risk of producing a false positive result in either the same run on the BD Viper LT System or in a subsequent run. Negative and positive samples were tested on each of three BD Viper LT Systems. Negative samples consisted of Q * Swab Diluent or LBC Specimen Dilution Tube with LBC Specimen Matrix (PreservCyt LBC media). Positive samples consisted of a representative analyte (at 10° CT EB/mL) spiked into Qx Swab Diluent or LBC Specimen Dilution Tube with LBC Specimen Matrix. The overall rate of contamination (i.e., with alternating columns of positive and negative samples and a prevalence of 50%) was 0.32% (2/630) for Q* Swab Diluent and 0.0% (0/630) for LBC Specimen Matrix. Contamination rates across the three BD Viper LT Systems are summarized in Table 2.

| BD Viper<br>LT<br>System | | Qˣ Sample Diluent | | | LBC Specimen Matrix | | |
|--------------------------|-----|---------------------|---------------------|--|---------------------|---------------------|---------------------|
| | n | Positive<br>Results | Percent<br>Positive | | n | Positive<br>Results | Percent<br>Positive |
| 1 | 210 | 0 | 0.00% | | 210 | 0 | 0.00% |
| 2 | 210 | 1 | 0.48% | | 210 | 0 | 0.00% |
| 3 | 210 | 1 | 0.48% | | 210 | 0 | 0.00% |
| Overall | 630 | 2 | 0.32% | | 630 | 0 | 0.00% |

#### Table 2 System Contamination

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Image /page/5/Picture/1 description: The image shows the BD logo, which consists of a stylized sun-like graphic to the left of the letters "BD" in bold, sans-serif font. Below the letters, there is a tagline that reads "Helping all people live healthy lives" in a smaller, sans-serif font. The logo is black and white.

# BD ProbeTec™ Neisseria gonorrhoeae (GC) O* Amplified DNA Assav on the BD Viper LT System

#### Clinical Performance Characteristics

The BD ProbeTec GCQ Assay formulation for the BD Viper LT System has not changed from that used with the BD Viper System in Extracted Mode. The following studies were conducted to support clinical performance of the BD Viper LT System.

Clinician-collected BD SurePath and PreservCyt specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female Q* UPT urine specimens were collected from 653 female subjects and 170 male subjects attending OB/GYN, sexually transmitted disease (STD) and family planning clinics at four geographically diverse clinical sites in North America. Subjects were classified as symptomatic if symptoms were reported by the subject. The final data analysis included 617 compliant female subjects and 167 compliant male subjects. All specimens were shipped to BD on cold packs for specimen screening, aliquoting, and comparison panel assembly.

Each comparison panel consisted of randomly chosen positive and negative specimens (based on BD Viper System in extracted mode reference results). The positive and negative specimens were randomized within the panel, and labeled such that the instrument user was blinded to the specimen results. Panels were identical across all of the BD Viper LT test sites. The blinded comparison panels were sent to the 3 external sites for testing on the BD Viper LT System and one internal site for testing using the BD Viper System in extracted mode with the BD ProbeTec GC Qx Assay.

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3 BD
BD BD

BD ProbeTec™ Neisseria gonorrhoeae (GC) QF
Amplified DNA Assay on the BD Viper LT Syster

PPA and NPA for the BD ProbeTec GCQ Assay on the BD Viper LT Systen Table 3:

| Gender | Specimen Type | Site | Positive Percent Agreement | | Negative Percent Agreement | |
|--------|---------------|-------|----------------------------|-----------------|----------------------------|-----------------|
| | | | Percent | 95% CI | Percent | 95% CI |
| Female | Vaginal Swab | A | 100.0% (27/27) | (87.5%, 100.0%) | 94.9% (75/79) | (87.7%, 98.0%) |
| | Vaginal Swab | B | 96.3% (26/27) | (81.7%, 99.3%) | 96.2% (76/79) | (89.4%, 98.7%) |
| | Vaginal Swab | C | 96.3% (26/27) | (81.7%, 99.3%) | 96.2% (76/79) | (89.4%, 98.7%) |
| | Vaginal Swab | Total | 97.5% (79/81) | (92.6%, 100.0%) | 95.8% (227/237) | (92.0%, 98.7%) |
| Female | Q'UPT | A | 96.3% (26/27) | (81.7%, 99.3%) | 100.0% (79/79) | (95.4%, 100.0%) |
| | Q'UPT | B | 100.0% (27/27) | (87.5%, 100.0%) | 100.0% (79/79) | (95.4%, 100.0%) |
| | Q'UPT | C | 96.3% (26/27) | (81.7%, 99.3%) | 100.0% (79/79) | (95.4%, 100.0%) |
| | Q'UPT | Total | 97.5% (79/81) | (92.6%, 100.0%) | 100.0% (237/237) | NA |
| Female | SurePath | A | 96.4% (27/28) | (82.3%, 99.4%) | 100.0% (78/78) | (95.3%, 100.0%) |
| | SurePath | B | 96.4% (27/28) | (82.3%, 99.4%) | 100.0% (78/78) | (95.3%, 100.0%) |
| | SurePath | C | 96.4% (27/28) | (82.3%, 99.4%) | 98.7% (77/78) | (93.1%, 99.8%) |
| | SurePath | Total | 96.4% (81/84) | (89.3%, 100.0%) | 99.6% (233/234) | (98.7%, 100.0%) |
| Female | PreservCyt. | A | 100.0% (27/27) | (87.5%, 100.0%) | 100.0% (79/79) | (95.4%, 100.0%) |
| | PreservCyt. | B | 100.0% (27/27) | (87.5%, 100.0%) | 100.0% (79/79) | (95.4%, 100.0%) |
| | PreservCyt. | C | 100.0% (27/27) | (87.5%, 100.0%) | 100.0% (79/79) | (95.4%, 100.0%) |
| | PreservCyt. | Total | 100.0% (81/81) | NA | 100.0% (237/237) | NA |
| | All | Total | 97.9% (320/327) | (95.1%, 100.0%) | 98.8% (934/945) | (97.9%, 99.6%) |
| Male | Q'UPT | A | 100.0% (40/40) | (91.2%, 100.0%) | 100.0% (73/73) | (95.0%, 100.0%) |
| | Q'UPT | B | 100.0% (40/40) | (91.2%, 100.0%) | 100.0% (73/73) | (95.0%, 100.0%) |
| | Q'UPT | C | 100.0% (40/40) | (91.2%, 100.0%) | 98.6% (72/73) | (92.6%, 99.8%) |
| | Q'UPT | Total | 100.0% (120/120) | NA | 99.5% (218/219) | (98.6%, 100.0%) |
| Total | All | Total | 98.4% (440/447) | (96.4%, 100.0%) | 99.0% (1152/1164) | (98.1%, 99.6%) |

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# BD ProbeTec™ Neisseria gonorrhoeae (GC) O* Amplified DNA Assay on the BD Viper LT System

#### Reproducibility

Reproducibility of the BD Viper LT System using the BD ProbeTec GCQ Amplified DNA Assay was evaluated at three test sites (two external clinical sites and one internal site) on one BD Viper LT System per site. Panels comprised of three levels of CT and GC organisms seeded into LBC specimen matrix (0.5 mL spiked into LBC Dilution Tubes for the BD ProbeTec Q* Amplified DNA Assays), vaginal matrix in Q* Swab Diluent (containing a clean male urethral swab), and urine specimen matrix (in Q UPT). CT and GC organisms were spiked into each specimen matrix. Uninoculated LBC specimen matrix, vaginal matrix in Q diluent, and urine matrix were used as negative samples. Two operators per site performed the BD Viper LT reproducibility study. Both operators ran one panel each day, over a total of eight days. A total of sixteen runs, each composed of 8 LBC, 8 swab and 8 UPT panel members described above were performed at each of two external BD Viper LT test sites and one internal BD Viper LT test site. The data are summarized in Table 4.

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8 BD
BD

10(k) Summar

BD ProbeTec™ Neisseria gonorrhoeae (GC) Q*
mplified DNA Assay on the BD Viper LT System

# mmary of Reproducibility Data on the BD Viper LT System for the BD ProbeTcc GCQ Assa Table 4:

| | | | | | | Within Run | | Between Run<br>within Day | | Between Day<br>within Site | | Between Site | | Total |
|------------------|-------------------|----------------|-----------------|--------|-------|------------|-------|---------------------------|------|----------------------------|------|--------------|-------|--------|
| Specimen<br>Type | Panel | % Correct | 95% CI | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| LBC | Negative | 100.0% (96/96) | (96.2 - 100.0%) | 3.3 | 9.2 | 280.1% | 0.0 | 0.0% | 0.0 | 0.0% | 2.2 | 65.4% | 9.5 | 287.6% |
| | High Negative | 20.8% (20/96) | (13.9 - 30.0%) | 560.2 | 425.0 | 75.9% | 49.0 | 8.7% | 0.0 | 0.0% | 0.0 | 0.0% | 427.8 | 76.4% |
| | Low Positive | 100.0% (96/96) | (96.2 - 100.0%) | 1415.9 | 231.4 | 16.3% | 172.0 | 12.1% | 0.0 | 0.0% | 28.1 | 2.0% | 289.7 | 20.5% |
| | Moderate Positive | 100.0% (94/94) | (96.1 - 100.0%) | 1631.9 | 169.7 | 10.4% | 93.7 | 5.7% | 70.9 | 4.3% | 0.0 | 0.0% | 206.4 | 12.6% |
| Swab | Negative | 99.0% (95/96) | (94.3 - 99.8%) | 41.6 | 180.1 | 432.6% | 13.2 | 31.6% | 0.0 | 0.0% | 0.0 | 0.0% | 180.6 | 433.8% |
| | High Negative | 13.5% (13/96) | (8.1 - 21.8%) | 871.5 | 562.4 | 64.5% | 0.0 | 0.0% | 0.0 | 0.0% | 88.2 | 10.1% | 569.2 | 65.3% |
| | Low Positive | 100.0% (95/95) | (96.1 - 100.0%) | 1687.5 | 297.7 | 17.6% | 0.0 | 0.0% | 0.0 | 0.0% | 34.7 | 2.1% | 299.7 | 17.8% |
| | Moderate Positive | 100.0% (96/96) | (96.2 - 100.0%) | 1819.2 | 163.3 | 9.0% | 48.2 | 2.7% | 43.3 | 2.4% | 73.3 | 4.0% | 190.3 | 10.5% |
| UPT | Negative | 100.0% (96/96) | (96.2 - 100.0%) | 3.6 | 8.0 | 221.8% | 0.0 | 0.0% | 0.0 | 0.0% | 0.0 | 0.0% | 8.0 | 221.8% |
| | High Negative | 18.8% (18/96) | (12.2 - 27.7%) | 766.6 | 502.1 | 65.5% | 0.0 | 0.0% | 75.8 | 9.9% | 15.8 | 2.1% | 508.0 | 66.3% |
| | Low Positive | 100.0% (96/96) | (96.2 - 100.0%) | 1593.6 | 224.9 | 14.1% | 86.6 | 5.4% | 36.7 | 2.3% | 0.0 | 0.0% | 243.8 | 15.3% |
| | Moderate Positive | 100.0% (96/96) | (96.2 - 100.0%) | 1741.5 | 126.1 | 7.2% | 86.2 | 5.0% | 35.1 | 2.0% | 21.5 | 1.2% | 158.2 | 9.1% |

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Image /page/9/Picture/1 description: The image shows the logo for BD, a global medical technology company. The logo consists of a stylized sun-like graphic with a human figure in the center, followed by the letters "BD" in bold, sans-serif font. Below the letters, there is a tagline that reads "Helping all people live healthy lives" in a smaller font.

# BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay on the BD Viper LT System

## Conclusions

The analytical and clinical study results for the BD ProbeTec Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay tested on the BD Viper LT System support the determination of substantial equivalence in accordance with the intended use as stated in the product labeling.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administrati 10903 New Hampshire Avenue Document Control Center - WO66-G Silver Spring, MD 20993-0002

May 20, 2014

Becton, Dickinson and Company Sherma Winston, M.S., RAC 7 Loveton Circle Sparks, MD 21152

Re: K140448

Trade/Device Name: BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay

Regulation Number: 21 CFR 866.3390 Regulation Name: Neisseria spp. direct serological test reagents Regulatory Class: II Product Code: LSL Dated: February 20, 2014 Received: February 21, 2014

Dear Ms. Winston:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tamara V. Feldblyum -S for

Sally Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number: K140448

Device Name: BD ProbeTec™ Neisseria gonorthoeae (GC) Q* Amplified DNA Assay

Indications for Use:

The BD ProbeTec Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay, when tested with either the BD Viper™ System in Extracted Mode or the BD Viper™ LT System, uses Strand Displacement Amplification technology for the direct, qualitative detection of Neisseria gonorrhoeae DNA in clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens (both UPT and Neat). The assay is also intended for use with gynecological specimens collected in BD SurePath™ Preservative Fluid or PreservCyt™ Solution using an aliquot that is removed prior to processing for either the BD SurePath or ThinPrep™ Pap test. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH)

Tamara V. Feidblyum -S 2014.05.16 15:38:53 -04'00'