Predicate Devices

Reference Devices

BD ProbeTec ET GC/AC assay, other commercially available NAAT

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on traditional molecular diagnostic techniques (SDA, fluorescence detection) and a rule-based algorithm for result reporting. There is no mention of AI or ML.

Therapeutic

No
The device is clearly indicated for diagnostic purposes ("to aid in the diagnosis of gonococcal urogenital disease"), not for treating or preventing disease.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the assay is "indicated for use with asymptomatic and symptomatic female individuals and symptomatic male individuals to aid in the diagnosis of gonococcal urogenital disease," which clearly defines it as a diagnostic device.

SaMD (Software as a Medical Device)

No

The device is a diagnostic assay that utilizes chemical reagents and a hardware system (BD Viper™ System) for amplification and detection. While it involves data processing and algorithms, it is not solely software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is for the "direct, qualitative detection of Neisseria gonorrhoeae DNA" in various human specimens (swabs and urine) to "aid in the diagnosis of gonococcal urogenital disease." This clearly indicates that the device is intended to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes.
Device Description: The description details the use of reagents, amplification technology (SDA), and detection methods (fluorescence) to analyze DNA extracted from patient specimens. This is consistent with the nature of an in vitro diagnostic test.
Specimen Types: The device is designed to test human specimens (swabs and urine), which is a hallmark of IVDs.
Performance Studies: The document includes performance studies (clinical performance and reproducibility) that evaluate the device's ability to accurately detect the target analyte in human specimens, a requirement for demonstrating the effectiveness of an IVD.
Key Metrics: The reporting of metrics like Sensitivity, Specificity, PPV, and NPV are standard for evaluating the performance of diagnostic tests.
Predicate Devices: The mention of predicate devices (BD ProbeTec ET CT/GC Amplified DNA Assay and APTIMA Combo 2 Assay) which are known IVDs, further supports that this device falls into the same category.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The BD ProbeTec™ Neisseria gonorrhoeae (GC) Q Amplified DNA Assay, when tested with the BD Viper™ System in Extracted Mode, uses Strand Displacement Amplification technology for the direct, qualitative detection of Neisseria gonorthoeae 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 indicated for use with asymptomatic and symptomatic females and symptomatic males to aid in the diagnosis of gonococcal urogenital disease.

Product codes

LSL

Device Description

The BD ProbeTec GC O' Amplified DNA Assay is based on the simultaneous amplification and detection of target DNA using amplification primers and a fluorescently-labeled detector probe. The reagents for 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. The BD Viper™ System pipettes a portion of the purified DNA solution from each Extraction Tube into a Priming Microwell to rehydrate the contents. After a brief incubation, the reaction mixture is transferred to a corresponding, pre-warmed Amplification Microwell which is sealed to prevent contamination and then incubated in one of the two thermallycontrolled fluorescent readers. The presence or absence of N. gonorrhoeae DNA is determined by calculating the peak fluorescence (Maximum Relative Fluorescent Units (MaxRFU)) over the course of the amplification process and by comparing this measurement to a predetermined threshold value.

In addition to the fluorescent probe used to detect amplified N. gonorrhoeae target DNA, a second labeled oligonucleotide is incorporated in each reaction Control (EC) oligonucleotide is labeled with a different dye than that used for detection of the N. gonorrhoeae-specific target and is used to confirm the validity of the extraction process. The EC is dried in the Extraction Tubes and is rehydrated upon addition of the specimen and extraction reagents. At the end of the extraction process, the EC fluorescence is monitored by the BD Viper System and an automated algorithm is applied to both the EC and N. gonorrhoeae-specific signals to report results as positive, negative, or EC failure.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

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).

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Clinician-collected, patient-collected (in a clinical setting).

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Clinical Performance Characteristics: Clinician-collected endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female O' UPT and neat urine specimens were collected from 1059 female subjects and 479 male subjects attending OB/GYN, sexually transmitted disease (STD) and family planning clinics at seven geographically diverse clinical sites in North America. Subjects were classified as symptomatic if they reported symptoms such as dysuria, urethral discharge, coital pain/difficulty/bleeding, testicular or scrotum pain/swelling, abnormal vaginal discharge, or pelvic/uterine/adnexal pain. Subjects were classified as asymptomatic if they did not report symptoms. Sixty five female subjects and 7 male subjects were excluded from the data analysis due to age requirement violations, antibiotic treatment in the last 21 days, opting to withdraw from the study after initially consenting, failure to obtain paired swab and urine specimens, urine quantity less than 20 mL, or transport and storage errors related to specimen collection. Therefore, the final data analysis included 994 compliant female subjects and 472 compliant male subjects.
Specimen Collection and Testing: Five specimens were collected from each of the 994 eligible female subjects. A urine specimen was collected and split into Q UPT, neat urine and the two reference urine specimen collection devices followed by a vaginal swab specimen and three randomized endocervical swab specimens. Up to four specimens were collected from each of the 472 eligible male subjects. Up to three randomized urethral swab specimens were collected followed by a urine specimen that was split into Q UPT, neat urine and the two reference urine specimen collection devices. BD ProbeTec GC Q assay results were generated from the Q* UPT and neat urine specimens, the vaginal swab specimen, one endocervical swab specimen and one male urethral swab specimen. The remaining two endocervical swab specimens, up to two male urethral swab specimens, and the two reference urine specimens for each male and female subject were tested using two reference methods: the BD ProbeTec ET GC/AC assay and another commercially available NAAT (Nucleic Acid Amplification Test). Specimen testing was conducted either at the site of collection or at a designated BD Viper testing site.
Patient Infected Status (PIS) Algorithm: All performance calculations were based on the total number of BD ProbeTec GC Q assays results for endocervical, vaginal and male urethral swab specimens, and male and female Q * UPT and neat urine specimens compared to a patient infected status (PIS) algorithm for each gender. In the algorithm, the designation of a subject as being infected with GC or not was based on endocervical swab and unne specimen results from the commercially available BD ProbeTec ET GC/AC assay and the other commercially available NAAT. Subjects were considered with GC if two of the four endocervical swab and urine specimens (or two of the three or four urethral swab and urine specimens) tested positive in the BD ProbeTec ET GC/AC assay and the other reference NAAT (one specimen testing positive in each NAAT). Subjects were considered non-infected if less than two reference NAAT results were positive. A total of 5387 BD ProbeTec GC Q* assay results was used to calculate sensitivity and specificity.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical Performance Characteristics:

Study Type: Clinical study comparing BD ProbeTec GC Q Assay to a patient infected status (PIS) algorithm based on two reference NAATs.
Sample Size: 994 compliant female subjects and 472 compliant male subjects. A total of 5387 BD ProbeTec GC Q* assay results were used.
Key Results: Sensitivity and specificity by specimen type and symptomatic status are presented in Table 3.
- Female Endocervical Swab (FS): Total N=992, Sensitivity 98.5% (64/65), Specificity 99.7% (924/927).
- Female Vaginal Swab (FV): Total N=993, Sensitivity 100.0% (65/65), Specificity 99.1% (920/928).
- Female Neat Urine (FN): Total N=993, Sensitivity 96.9% (63/65), Specificity 99.5% (923/928).
- *Female urine in Q UPT (FUPT)**: Total N=993, Sensitivity 98.5% (64/65), Specificity 99.7% (925/928).
- Male Urethral Swab (MS): Total N=472, Sensitivity 100.0% (107/107), Specificity 99.5% (363/365).
- Male Neat Urine (MN): Total N=472, Sensitivity 100.0% (107/107), Specificity 99.2% (362/365).
- *Male urine in Q UPT (MUPT)**: Total N=472, Sensitivity 100.0% (107/107), Specificity 99.2% (362/365).
- Overall Total: N=5387, Sensitivity 99.3% (577/581), Specificity 99.4% (4779/4806).

Reproducibility Study 1:

Study Type: Reproducibility study at three clinical sites.
Sample Size: Nine replicates of each panel member tested every day for five days on each BD Viper System. Total samples tested were 135 for Endocervical/Urethral and 135 for Urine/Vaginal per panel member.
Key Results: Summary of reproducibility data on the BD Viper System for the GC Q Assay for various CT and GC cell concentrations in endocervical/urethral and urine/vaginal specimens, showing Mean MaxRFU, SD within run, between run, and within site. Proportion positive ranged from 98.5% to 100.0%.

Reproducibility Study 2 (Internal Study Characterizing Reproducibility at Target Levels below LOD):

Study Type: Internal study to characterize the reproducibility of test results (proportion positive or negative) at target levels below the analytical Limit of Detection (LOD).
Sample Size: Fifteen replicates of each panel member tested every day for five days across three BD Viper Systems (Total 225 samples per panel member).
Key Results: Demonstrated reproducibility for targets at 1:10 and 1:100 dilution below LOD.
- Endocervical/Urethral 1:10: Positive 92.9% (209/225), Negative 7.1% (16/225).
- Endocervical/Urethral 1:100: Positive 30.7% (69/225), Negative 69.3% (156/225).
- Urine/Vaginal 1:10: Positive 90.7% (204/225), Negative 8.3% (21/225).
- Urine/Vaginal 1:100: Positive 22.7% (51/225), Negative 77.3% (174/225).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Sensitivity:
- Female endocervical swab: 98.5% (64/65)
- Female vaginal swab: 100.0% (65/65)
- Female neat urine: 96.9% (63/65)
- Female urine in Q* UPT: 98.5% (64/65)
- Male urethral swab: 100.0% (107/107)
- Male neat urine: 100.0% (107/107)
- Male urine in Q* UPT: 100.0% (107/107)
- Overall Total: 99.3% (577/581)
Specificity:
- Female endocervical swab: 99.7% (924/927)
- Female vaginal swab: 99.1% (920/928)
- Female neat urine: 99.5% (923/928)
- Female urine in Q* UPT: 99.7% (925/928)
- Male urethral swab: 99.5% (363/365)
- Male neat urine: 99.2% (362/365)
- Male urine in Q* UPT: 99.2% (362/365)
- Overall Total: 99.4% (4779/4806)
PPV%:
- Female endocervical swab: 95.5
- Female vaginal swab: 89.0
- Female neat urine: 92.6
- Female urine in Q* UPT: 95.5
- Male urethral swab: 98.2
- Male neat urine: 97.3
- Male urine in Q* UPT: 97.3
- Overall Total: 95.5
NPV%:
- Female endocervical swab: 99.9
- Female vaginal swab: 100.0
- Female neat urine: 99.8
- Female urine in Q* UPT: 99.9
- Male urethral swab: 100.0
- Male neat urine: 100.0
- Male urine in Q* UPT: 100.0
- Overall Total: 99.9

Predicate Device(s)

BD ProbeTec ET CT/GC Amplified DNA Assay (K984631), APTIMA Combo 2 Assay (K003395)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 866.3390

Neisseria spp. direct serological test reagents.(a)
Identification. Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identifyNeisseria spp. from cultured isolates. Additionally, some of these reagents consist ofNeisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence ofNeisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusNeisseria, 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.(b)
Classification. Class II (performance standards).

Summary

0

Korres

Image /page/0/Picture/1 description: The image shows the logo for BD, a medical technology company. The logo consists of two parts: a graphic symbol on the left and the letters "BD" on the right. Below the letters, there is a tagline that reads "Helping all people live healthy lives." The graphic symbol appears to be a stylized representation of a person with outstretched arms under a sun-like shape.

BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay

| Applicant | BD Diagnostic Systems
7 Loveton Circle
Sparks, MD 21152 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| | DEC 11 2008 |
| Establishment Registration No. | 1119779 |
| Contact Person | Kathryn Babka Carr, RAC
tel. 410-316-4260
fax. 410-316-4041
Kathy.Carr@bd.com |
| Summary Date | December 1, 2008 |
| Proprietary Name | BD ProbeTec™ Neisseria gonorrhoeae (GC) Q x Amplified 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 Devices | BD ProbeTec ET CT/GC Amplified DNA Assay (K984631),
APTIMA Combo 2 Assay (K003395) |

Device Description

The BD ProbeTec GC O' Amplified DNA Assay is based on the simultaneous amplification and detection of target DNA using amplification primers and a fluorescently-labeled detector probe. The reagents for 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. The BD Viper™ System pipettes a portion of the purified DNA solution from each Extraction Tube into a Priming Microwell to rehydrate the contents. After a brief incubation, the reaction mixture is transferred to a corresponding, pre-warmed Amplification Microwell which is sealed to prevent contamination and then incubated in one of the two thermallycontrolled fluorescent readers. The presence or absence of N. gonorrhoeae DNA is determined by calculating the peak fluorescence (Maximum Relative Fluorescent Units (MaxRFU)) over the course of the amplification process and by comparing this measurement to a predetermined threshold value.

In addition to the fluorescent probe used to detect amplified N. gonorrhoeae target DNA, a second labeled oligonucleotide is incorporated in each reaction Control (EC) oligonucleotide is labeled with a different dye than that used for detection of the N. gonorrhoeae-specific target and is used to confirm the validity of the extraction process. The EC is dried in the Extraction Tubes and is rehydrated

1

Image /page/1/Picture/1 description: The image shows the logo for BD, a medical technology company. The logo consists of a stylized sun-like graphic on the left and the letters "BD" in bold font on the right. Below the letters, there is a tagline that reads "Helping all people live healthy lives".

BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay

upon addition of the specimen and extraction reagents. At the end of the extraction process, the EC fluorescence is monitored by the BD Viper System and an automated algorithm is applied to both the EC and N. gonorrhoeae-specific signals to report results as positive, negative, or EC failure.

Intended Use

The BD ProbeTec™ Neisseria gonorrhoeae (GC) Q Amplified DNA Assay, when tested with the BD Viper™ System in Extracted Mode, uses Strand Displacement Amplification technology for the direct, qualitative detection of Neisseria gonorthoeae 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 indicated for use with asymptomatic and symptomatic females and symptomatic males to aid in the diagnosis of gonococcal urogenital disease.

Summarv and Principles of Operation

When used with the BD Viper System, the BD ProbeTec GC Q* Amplified DNA Assay (GC Q* Assay) involves automated extraction of DNA from clinical specimens through the chemical lysis of cells, followed by binding of DNA to para-magnetic particles, washing of the bound nucleic acid and elution in an amplification-compatible buffer. When present, N. gonorrhoeae DNA is then detected by Strand Displacement Amplification (SDA) of a specific target sequence in the presence of a fluorescently labeled detector probe.

Analytical Performance Characteristics

Limit of Detection (Analytical Sensitivity)

The Limits of Detection (LODs) for the GC Q* Assay with Neisseria gonorrhoeae strain ATCC 19424 in urine and swab specimens when extracted on the BD Viper System were determined to be ≤ 50 cells per mL for neat and UPT treated urine and ≤ 100 GC cells per mL for expressed vaginal and endocervical swab specimens. The GC Q' Assay on the BD Viper System in extracted mode was able to detect 17 GC strains with ≥ 95% proportion positive at a concentration of 50 cells per mL in Q* Swab Diluent.

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BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay

Analytical Specificity

The 141 organisms listed in Table 1 were tested with the BD ProbeTec GC Q Amplified DNA Assay on the BD Viger System. All potential cross-reactive species were tested at ≥ 1x10° cells/mL except where noted. Two N. cinerea and two N. lactamica strains were shown to cross-react with the GC Q* assay.

Table 1: Potential Cross-reactant Microorganisms
Acinetobacter calcoaceticus	Epstein Barr Virus ***	Peptostreptococcus productus	Neisseria elongata subsp.
nitroreduscens (2)
Acinetobacter Iwoffi	Escherichia coli	Plesiomonas shigelloides	Neisseria elongata
Actinomyces israelii	Flavobacterium meningosepticum	Propionibacterium acnes	Neisseria flava (4)
Adenovirus***	Gardnerella vaginalis	Providencia stuartii	Neisseria flavescens (4)
Aeromonas hydrophilia	Gemella haemolysans	Pseudomonas aeruginosa	Neisseria gonorrhoeae
Alcaligenes faecalis*	Haemophilus influenzae	Salmonella minnesota	Neisseria lactamica (7)
Bacillus subtilis*	Herpes Simplex Virus **	Salmonella typhimurium	Neisseria meningitidis (12)
Bacteroides fragilis	Human papillomavirus (16 and 18)***	Staphylococcus aureus	Neisseria mucosa (5)
Candida albicans*	Kingella kingae	Staphylococcus epidermidis	Neisseria perflava (8)
Candida glabrata*	Klebsiella pneumoniae	Streptococcus agalactiae	Neisseria polysaccharea (2)
Candida tropicalis*	Lactobacillus acidophilus*	Streptococcus mitis	Neisseria sicca (5)
Chlamydia pneumoniae****	Lactobacillus brevis	Streptococcus mutans	Neisseria subflava (15)
Chlamydia psittaci*	Lactobacillus jensenii*	Streptococcus pneumoniae*	Neisseria weaverii (3)
Citrobacter freundii	Listeria monocytogenes	Streptococcus pyogenes
Clostridium perfringens	Mobiluncus mulieris	Streptomyces griseus**
Corynebacterium renale	Moraxella lacunata*	Trichomonas vaginalis**
Cryptococcus neoformans*	Moraxella osloensis	Veillonella parvula
Cytomegalovirus**	Morganella morganii	Vibrio parahaemolyticus
Edwardsiella turda	Mycobacterium gordonae	Yersinia enterocolitica
Enterobacter cloacae	Mycobacterium smegmatis	Branhamella catarrhalis (5)
Enterococcus faecalis	Peptostreptococcus anaerobius	Neisseria cinerea (2)
		Neisseria elongata ss

(n) number of strains tested in the BD ProbeTec GC Q4 Assay

Tested at > I x IO' cells on > I x 10' cells or viral particles per mL; ** Tested at ≥ 1 x l 0" genomic equivalents per mL;
*** tested at > I x IO' TCDwinL

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BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay

Interfering Substances

Potential interfering substances which may be encountered in swab and/or urine specimens were extracted from urine and vaginal swab matrix in the absence and presence of GC target (150 GC cells/mL for urine and 300 GC cells/mL for swabs) and tested with the BD ProbeTec GC Q* Amplified DNA Assay on the BD Viper System. Results are summarized in Table 2.

Interpretation	Swab	Urine
No Interference
Observed	Blood (≤ 60%)	Blood (1%)
	Seminal Fluid	Seminal fluid
	Mucus	Mucus
	Over The Counter vaginal products and
contraceptives	Antibiotics
	Hemorrhoidal cream	Analgesics
	Prescription vaginal treatments	Over The Counter deodorant sprays
and powders
	Leukocytes (1x106 cells/mL)	Hormones
	1x106 cells/mL Chlamydia trachomatis	Leukocytes
		Albumin 60%)

Table 2: Interfering Substances

Clinical Performance Characteristics

Clinician-collected endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female O' UPT and neat urine specimens were collected from 1059 female subjects and 479 male subjects attending OB/GYN, sexually transmitted disease (STD) and family planning clinics at seven geographically diverse clinical sites in North America. Subjects were classified as symptomatic if they reported symptoms such as dysuria, urethral discharge, coital pain/difficulty/bleeding, testicular or scrotum pain/swelling, abnormal vaginal discharge, or pelvic/uterine/adnexal pain. Subjects were classified as asymptomatic if they did not report symptoms. Sixty five female subjects and 7 male subjects were excluded from the data analysis due to age requirement violations, antibiotic treatment in the last 21 days, opting to withdraw from the study after initially consenting, failure to obtain paired swab and urine specimens, urine quantity less than 20 mL, or

4

Image /page/4/Picture/1 description: The image shows the logo for BD, a medical technology company. The logo consists of two parts: a symbol on the left and the letters "BD" on the right. The symbol appears to be a stylized representation of a person with outstretched arms, surrounded by a sun-like shape. Below the letters "BD" is the company's slogan: "Helping all people live healthy lives."

BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay

transport and storage errors related to specimen collection. Therefore, the final data analysis included 994 compliant female subjects and 472 compliant male subjects.

Five specimens were collected from each of the 994 eligible female subjects. A urine specimen was collected and split into Q UPT, neat urine and the two reference urine specimen collection devices followed by a vaginal swab specimen and three randomized endocervical swab specimens. Up to four specimens were collected from each of the 472 eligible male subjects. Up to three randomized urethral swab specimens were collected followed by a urine specimen that was split into Q UPT, neat urine and the two reference urine specimen collection devices. BD ProbeTec GC Q assay results were generated from the Q* UPT and neat urine specimens, the vaginal swab specimen, one endocervical swab specimen and one male urethral swab specimen. The remaining two endocervical swab specimens, up to two male urethral swab specimens, and the two reference urine specimens for each male and female subject were tested using two reference methods: the BD ProbeTec ET GC/AC assay and another commercially available NAAT (Nucleic Acid Amplification Test). Specimen testing was conducted either at the site of collection or at a designated BD Viper testing site.

All performance calculations were based on the total number of BD ProbeTec GC Q assays results for endocervical, vaginal and male urethral swab specimens, and male and female Q * UPT and neat urine specimens compared to a patient infected status (PIS) algorithm for each gender. In the algorithm, the designation of a subject as being infected with GC or not was based on endocervical swab and unne specimen results from the commercially available BD ProbeTec ET GC/AC assay and the other commercially available NAAT. Subjects were considered with GC if two of the four endocervical swab and urine specimens (or two of the three or four urethral swab and urine specimens) tested positive in the BD ProbeTec ET GC/AC assay and the other reference NAAT (one specimen testing positive in each NAAT). Subjects were considered non-infected if less than two reference NAAT results were positive. A total of 5387 BD ProbeTec GC Q* assay results was used to calculate sensitivity and specificity. Sensitivity and specificity by specimen type and symptomatic status are presented in Table 3.

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BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay

Table 3: GC Q Assay Performance Compared to Patient Infected Status (by specimen type and symptomatic status)

| Specimen
Type | Symptomatic | N Initial/Final |
|------------------|-- | FS | N | | Y | | FV | N | | Y | | FN | N | | Y | | FUPT | N | | Y | | MS | N | | Y | | MN | N | | Y | | MUPT | N | | Y | | Total | | Sensitivity | 95% C.I. | Specificity | 95% C.I. | PPV% | NPV% | Error
-----------|------|------------------|------------------|-------------------|------------------|-------|-------|------------------------|
| 450 | 96.3% (26/27) | (81.0%-99.9%) | 99.5% (421/423) | (98.3%-99.9%) | 92.9 | 99.8 | 3/0 |
| 542 | 100.0% (38/38) | (90.7%-100.0%) | 99.8% (503/504) | (98.9% -100.0%) | 97.4 | 100.0 | 2/2 |
| Total | 992 | 98.5% (64/65) | (91.7% - 100.0%) | 99.7% (924/927) | (99.1%-99.9%) | 95.5 | 99.9 | 5/2 |
| 449 | 100.0% (27/27) | (87.2%-100.0%) | 98.6% (416/422) | (96.9%-99.5%) | 81.8 | 100.0 | 0/0 |
| 544 | 100.0% (38/38) | (90.7%-100.0%) | 99.6% (504/506) | (98.6%-100.0%) | 95.0 | 100.0 | 0/0 |
| Total | 993 | 100.0% (65/65) | (94.5% - 100.0%) | 99.1% (920/928) | (98.3%-99.6%) | 89.0 | 100.0 | 0/0 |
| 450 | 96.3% (26/27) | (81.0%-99.9%) | 99.3% (420/423) | (97.9%-99.9%) | 89.7 | 99.8 | 0/0 |
| 543 | 97.4% (37/38) | (86.2%-99.9%) | 99.6% (503/505) | (98.6% -100.0%) | 94.9 | 99.8 | 0/0 |
| Total | 993 | 96.9% (63/65) | (89.3%-99.6%) | 99.5% (923/928) | (98.7%-99.8%) | 92.6 | 99.8 | 0/0 |
| 450 | 100.0% (27/27) | (87.2%-100.0%) | 99.5% (421/423) | (98.3%-99.9%) | 93.1 | 100.0 | 0/0 |
| 543 | 97.4% (37/38) | (86.2% -99.9%) | 99.8% (504/505) | (98.9% -100.0%) | 97.4 | 99.8 | 0/0 |
| Total | 993 | 98.5% (64/65) | (91.7%-100.0%) | 99.7% (925/928) | (99.1%-99.9%) | 95.5 | 99.9 | 0/0 |
| 215 | 100.0% (7/7) | (59.0% - 100.0%) | 100.0% (208/208) | (98.2% - 100.0%) | 100.0 | 100.0 | 0/0 |
| 257 | 100.0% (100/100) | (96.4% - 100.0%) | 98.7% (155/157) | (95.5%-99.8%) | 98.0 | 100.0 | 1/0 |
| Total | 472 | 100.0% (107/107) | (96.6% - 100.0%) | 99.5% (363/365) | (98.0%-99.9%) | 98.2 | 100.0 | 1/0 |
| 215 | 100.0% (7/7) | (59.0% - 100.0%) | 100.0% (208/208) | (98.2% -100.0%) | 100.0 | 100.0 | 0/0 |
| 257 | 100.0% (100/100) | (96.4%-100.0%) | 98.1% (154/157) | (94.5%-99.6%) | 97.1 | 100.0 | 0/0 |
| Total | 472 | 100.0% (107/107) | (96.6%-100.0%) | 99.2% (362/365) | (97.6%-99.8%) | 97.3 | 100.0 | 0/0 |
| 215 | 100.0% (7/7) | (59.0% - 100.0%) | 99.5% (207/208) | (97.4% - 100.0%) | 87.5 | 100.0 | 0/0 |
| 257 | 100.0% (100/100) | (96.4%-100.0%) | 98.7% (155/157) | (95.5%-99.8%) | 98.0 | 100.0 | 0/0 |
| Total | 472 | 100.0% (107/107) | (96.6% - 100.0%) | 99.2% (362/365) | (97.6%-99.8%) | 97.3 | 100.0 | 0/0 |
| 5387 | 99.3% (577/581) | (98.2% - 99.8%) | 99.4% (4779/4806) | (99.2%-99.6%) | 95.5 | 99.9 | 6/2 |

A	Asymptomatic
CI	Confidence Interval
FNU	Female Neat Urine
FS	Female endocervical swab
FUPT	Female urine in Q* UPT
FV	Female vaginal swab
MNU	Male Neat Urine
MS	Male urethral swab
MUPT	Male urine in Q* UPT
n	number
S	Symptomatic

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Image /page/6/Picture/1 description: The image shows the logo for BD, a medical technology company. The logo consists of two parts: a graphic symbol on the left and the letters "BD" on the right. Below the letters, there is a tagline that reads "Helping all people live healthy lives." The graphic symbol appears to be a stylized representation of a person with arms raised, surrounded by rays or petals, possibly symbolizing health and well-being.

BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay

A total of 5387 GC Q Assay results was evaluated at seven geographically diverse clinical sites. A frequency distribution of the initial MaxRFU values for the GC Q' Assay with an assay cutoff of 125 MaxRFU is shown in Figure A.

Image /page/6/Figure/4 description: The image is a bar graph showing the frequency of MaxPFU. The x-axis shows the MaxPFU ranges, and the y-axis shows the frequency. The bar graph shows that the most frequent MaxPFU range is 0-49, with a frequency of 4765. The MaxPFU range of >=800 has a frequency of 594.

Image /page/6/Figure/5 description: The image shows the title of a figure. The title is "Figure A: Frequency Distribution of MaxRFU for the GC Q* Assay". The title is written in a clear, sans-serif font and is centered on the image.

7

Image /page/7/Picture/1 description: The image shows the logo for BD, a global medical technology company. The logo consists of two parts: a stylized graphic on the left and the letters "BD" on the right. The graphic resembles a person with arms raised towards a sun-like burst of light. Below the logo, the tagline reads "Helping all people live healthy lives" in a smaller font.

BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay

Reproducibility

Reproducibility of the BD Viper System using the BD ProbeTec GC Q* Assay was evaluated at three clinical sites on one BD Viper System per site. A panel of simulated specimens was tested that comprised CT and GC organisms seeded into swab diluent for the BD ProbeTec GC Q* Assay. Simulated endocervical and urethral specimens contained a clean endocervical swab whereas the simulated urine and vaginal swab specimens did not. Uninoculated swab diluent for the BD ProbeTec GC Q* Assay was used for the GC negative samples. Nine replicates of each panel member were tested every day for five days on each BD Viper System. The data are summarized in Table 4.

Specimen Type	CT, EB/ml	GC Cells/ml		Within Run	Between Run	Within Site
				Mean	SD	Mean	SD
Endocervical/
Urethral	0	0	99.3%
(134/135)	(95.9%,
100.0%)	13.8	151.3	1096.3	0.0	0.0	0.6	4.3
	30	0	98.5%
(133/135)	(94.8%,
99.8%)	28.1	220.7	785.3	0.0	0.0	33.8	120.3
	0	100	100.0%
(135/135)	(97.3%,
100.0%)	1859.5	94.1	5.1	0.0	0.0	19.2	1.0
	30	250	100.0%
(135/135)	(97.3%,
100.0%)	1847.3	117.6	6.4	0.0	0.0	25.9	1.4
	75	100	100.0%
(135/135)	(97.3%,
100.0%)	1855.9	119.4	6.4	0.0	0.0	42.2	2.3
Urine/Vaginal	0	0	99.3%
(134/135)	(95.9%,
100.0%)	15.7	162.3	1031.1	0.0	0.0	0.0	0.0
	30	0	100.0%
(135/135)	(97.3%,
100.0%)	1.1	3.1	295.8	0.7	69.7	0.5	48.3
	0	100	100.0%
(135/135)	(97.3%,
100.0%)	1899.0	86.1	4.5	22.8	1.2	0.0	0.0
	30	250	100.0%
(135/135)	(97.3%,
100.0%)	1884.2	94.0	5.0	13.8	0.7	0.0	0.0
	75	100	100.0%
(135/135)	(97.3%,
100.0%)	1867.2	87.7	4.7	0.0	0.0	19.2	1.0

Table 4: Summary of Reproducibility Data on the BD Viper System for the GC Q Assay

A sccond study was conducted internally to characterize the reproducibility of test results (i.e., proportion positive or negative) at target levels below the analytical Limit of Detection (LOD) of the BD ProbeTec GC Q Assay. A panel of simulated specimens was tested that comprised GC and CT organisms seeded into Q* swab diluent at two different levels each of which was below the respective analytical LOD for the organisms (1:10, 1:100). These levels were selected to fall within the dynamic range of the analytical L.OD curve of the assay. Fifteen replicates of each panel member were tested every day for five days across three BD Viper Systems. The data are summarized in Table 5.

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BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay

Table 15: Characterization of System Reproducibility at Target Levels below the Analytical Limit of Detection for the GC Q* Assay

| 2007 10:50 PM 11 | Beginning
ੇਰਾ (ਕਿਸ (ਸੰਮਾ) ( | 19 1985 1978 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 1 | 11/24/2019 | 11:12 201
1977 - 199 | And The First of the first of the first of the first of the first of the first of the first of the first of the first of the first of the first and | | | |
|-----------------------|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|--------------|------|--|
| | | | | 1 1 2 2017 12 | | | | |
| Endocervical/Urethral | 1:10 | 92.9
(209/225) | (88.7, 95.9) | 1324.6 | 7.1
(16/225) | (4.1, 11.3) | 41.4 | |
| Endocervical/Urethral | 1:100 | 30.7
(69/225) | (24.7. 37.1) | 835.9 | 69.3
(156/225) | (62.9, 75.3) | 7.2 | |
| Urine/Vaginal | 1:10 | 90.7
(204/225) | (86.1, 94.1) | 1165.9 | 8.3
(21/225) | (5.9, 13.9) | 34.2 | |
| Urine/Vaqinal | 1:100 | 22.7
(51/225) | (17.4 28.7) | 872.7 | 77.3
(174/225) | (71.3, 82.6) | 7.8 | |

Conclusions

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

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kathryn Babka Carr Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152

DEC 1 1 2008

Re: K081825

Trade/Device Name: BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Regulation Number: 21 CFR 866.3390 Regulation Name: Neisseria spp. direct serological test reagents Regulatory Class: Class II Product Code: LSL Dated: December 5, 2008 Received: December 9, 2008

Dear Ms. Babka Carr:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sally attayata

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K081825

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

Indications For Use:

The BD ProbeTec Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay, when tested with the BD Viper™ System in extracted mode, uses Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Neisseria gonorrhoeae DNA in cliniciancollected female endocervical and male urethral swabs, patient-collected vaginal swab specimens (in a clinical setting), and female and male urine specimens. The assay is indicated for use with asymptomatic and symptomatic female individuals and symptomatic male individuals to aid in the diagnosis of gonococcal urogenital disease.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Uve Schuf

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K081825

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BD Diagnostic Systems Becton, Dickinson and Company

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