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.

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.

AI/ML Overview

The document describes the BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay, a diagnostic device for detecting Neisseria gonorrhoeae.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific sensitivity and specificity thresholds that the device must meet. Instead, it presents the assay's performance characteristics (Sensitivity, Specificity, PPV, NPV) against a "Patient Infected Status (PIS) algorithm" as a measure of its effectiveness.

However, based on the submission being for a 510(k) and the conclusion stating "The analytical and clinical study results... support the determination of substantial equivalence in accordance with the intended use," it can be inferred that the reported performance metrics were considered acceptable for deeming the device substantially equivalent to predicate devices.

Here's a summary of the clinical performance:

Metric	Overall Reported Performance (Across all specimen types, symptomatic statuses)
Sensitivity	99.3% (95% CI: 98.2% - 99.8%)
Specificity	99.4% (95% CI: 99.2% - 99.6%)
PPV	95.5%
NPV	99.9%

Analytical Acceptance Criteria and Reported Performance:

Criterion	Acceptance Criteria (Implied)	Reported Device Performance
Limit of Detection (Analytical Sensitivity)	To detect N. gonorrhoeae at low concentrations.	Urine: ≤ 50 cells per mL (for neat and UPT treated urine) Swabs: ≤ 100 GC cells per mL (for expressed vaginal and endocervical swab specimens) Detected 17 GC strains with ≥ 95% proportion positive at 50 cells per mL in Q* Swab Diluent.
Analytical Specificity	To avoid cross-reactivity with common microorganisms.	Tested against 141 organisms. Two N. cinerea and two N. lactamica strains showed cross-reactivity. All other tested organisms did not cross-react.
Interfering Substances	Performance should not be significantly impacted by common substances.	No Interference Observed: Blood, seminal fluid, mucus, various vaginal products/contraceptives, hemorrhoidal cream, prescription vaginal treatments, antibiotics, analgesics, deodorant sprays/powders, hormones, leukocytes, albumin, glucose, acidic/alkaline urine, bilirubin, organisms associated with UTIs.May cause EC failures: Blood (>60%) in Swab specimens.
Reproducibility	Consistent results across different sites and runs.	Assessed by proportion positive/negative and coefficient of variation (SD, %CV) (details in Table 4 and 5). Demonstrated high reproducibility for both positive and negative samples, and even for samples below LOD.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Clinical Performance:
- Female Subjects: 994
- Male Subjects: 472
- Total BD ProbeTec GC Q Assay results used for sensitivity/specificity calculations:* 5387
Data Provenance:
- Country of Origin: North America (seven geographically diverse clinical sites).
- Retrospective or Prospective: Prospective. Specimens were "collected from 1059 female subjects and 479 male subjects attending OB/GYN, sexually transmitted disease (STD) and family planning clinics."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The ground truth was not established by medical experts' consensus or interpretation. Instead, it was established by a Patient Infected Status (PIS) algorithm relying on the results of two other commercially available Nucleic Acid Amplification Tests (NAATs). Therefore, the concept of "number of experts" and "qualifications of those experts" does not directly apply in this context for the clinical performance ground truth.

4. Adjudication Method for the Test Set

The adjudication method for determining the "Patient Infected Status (PIS)" was an algorithm based on the results of the two reference NAATs:

For females: Subjects were considered infected with GC if two of the four endocervical swab and urine specimens (from a total of two endocervical swabs and two urine specimens) tested positive in both the BD ProbeTec ET GC/AC assay AND the other commercially available NAAT (i.e., one specimen testing positive in each NAAT).
For males: Subjects were considered infected with GC if two of the three or four urethral swab and urine specimens tested positive in both the BD ProbeTec ET GC/AC assay AND the other commercially available NAAT (i.e., one specimen testing positive in each NAAT).
Non-infected: Subjects were considered non-infected if less than two reference NAAT results were positive.

This is a form of composite reference standard or adjudication by algorithm based on multiple reference tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The study evaluates the performance of the device (assay) in standalone mode against a composite reference standard, not its impact on human reader performance or diagnostic accuracy with AI assistance. This device is a diagnostic assay, not an AI-assisted interpretation tool for human readers.

6. Standalone Performance

Yes, a standalone (algorithm only without human-in-the-loop performance) study was performed. The entire clinical performance evaluation described in the document, comparing the BD ProbeTec GC Q* Assay results to the PIS algorithm, is a standalone performance study of the diagnostic assay. This assay is designed to provide a qualitative (positive/negative) result without human interpretation of raw data for diagnosis.

7. Type of Ground Truth Used

The ground truth used for clinical performance was a composite reference standard or Patient Infected Status (PIS) algorithm. This algorithm was established using the results from two other commercially available Nucleic Acid Amplification Tests (NAATs): the BD ProbeTec ET GC/AC assay and another unnamed commercially available NAAT. It is not pathology, expert consensus, or outcomes data in the traditional sense, but rather a best available evidence standard from established molecular diagnostics.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or "validation set" in the context of machine learning. The clinical performance study described used a total of 994 female subjects and 472 male subjects as the test set to evaluate the device. For analytical performance (LOD, specificity), various spiked samples and clinical isolates were used. For the clinical study, it appears the entire subject cohort served as the evaluation set against the composite reference standard.

9. How the Ground Truth for the Training Set Was Established

Since a distinct "training set" for an AI or machine learning model is not explicitly mentioned, the question of how its ground truth was established is not directly applicable. If one considers the overall development of the assay, the analytical studies (LOD, specificity) would have informed the assay's design and cutoff values, where the ground truth was known by design (e.g., specific concentrations of N. gonorrhoeae for LOD, known organisms for specificity). The clinical ground truth relied on the PIS algorithm as detailed in point 4 and 7.

Summary

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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 Systems7 Loveton CircleSparks, MD 21152
	DEC 11 2008
Establishment Registration No.	1119779
Contact Person	Kathryn Babka Carr, RACtel. 410-316-4260fax. 410-316-4041Kathy.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

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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 InterferenceObserved	Blood (≤ 60%)	Blood (1%)
	Seminal Fluid	Seminal fluid
	Mucus	Mucus
	Over The Counter vaginal products andcontraceptives	Antibiotics
	Hemorrhoidal cream	Analgesics
	Prescription vaginal treatments	Over The Counter deodorant spraysand powders
	Leukocytes (1x106 cells/mL)	Hormones
	1x106 cells/mL Chlamydia trachomatis	Leukocytes
		Albumin <1 mg/mL
		Glucose
		Acidic urine (pH 4.0)
		Alkaline urine (pH 9.0)
		Bilirubin
		Organisms associated with UrinaryTract Infections

May causeextraction control(EC) failures	Blood (> 60%)	Not observed

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

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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)

SpecimenType	Symptomatic	N	Sensitivity	95% C.I.	Specificity	95% C.I.	PPV%	NPV%	ErrorInitial/Final
FS	N	450	96.3% (26/27)	(81.0%-99.9%)	99.5% (421/423)	(98.3%-99.9%)	92.9	99.8	3/0
	Y	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
FV	N	449	100.0% (27/27)	(87.2%-100.0%)	98.6% (416/422)	(96.9%-99.5%)	81.8	100.0	0/0
	Y	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
FN	N	450	96.3% (26/27)	(81.0%-99.9%)	99.3% (420/423)	(97.9%-99.9%)	89.7	99.8	0/0
	Y	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
FUPT	N	450	100.0% (27/27)	(87.2%-100.0%)	99.5% (421/423)	(98.3%-99.9%)	93.1	100.0	0/0
	Y	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
MS	N	215	100.0% (7/7)	(59.0% - 100.0%)	100.0% (208/208)	(98.2% - 100.0%)	100.0	100.0	0/0
	Y	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
MN	N	215	100.0% (7/7)	(59.0% - 100.0%)	100.0% (208/208)	(98.2% -100.0%)	100.0	100.0	0/0
	Y	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
MUPT	N	215	100.0% (7/7)	(59.0% - 100.0%)	99.5% (207/208)	(97.4% - 100.0%)	87.5	100.0	0/0
	Y	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
Total		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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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.

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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	Beginningੇਰਾ (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 2011977 - 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:

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

Page 1 of 1

BD Diagnostic Systems Becton, Dickinson and Company

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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).