The BD ProbeTect™ 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 and male individuals to aid in the diagnosis of gonococcal urogenital disease.

The BD Viper System, when used with the BD ProbeTec amplified nucleic assay(s), is intended for the in vitro detection of targeted organisms from specimens as identified in the assay-specific reagent package insert(s).

Device Description

The BD ProbeTec GC Q* 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 "M 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 thermally-controlled 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. The Extraction 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

Here's an analysis of the acceptance criteria and study detailed in the provided text for the BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the clinical performance results, where high sensitivity and specificity are demonstrated across various specimen types and patient asymptomatic/symptomatic statuses. While explicit numerical acceptance criteria (e.g., "sensitivity must be >95%") are not explicitly stated as 'acceptance criteria' in the document, we can infer the achieved performance as the criteria met for substantial equivalence.

Specimen Type & Symptomatic Status	Acceptance Criteria (Implied by Achieved Performance)	Reported Device Performance (Sensitivity)	Reported Device Performance (Specificity)
Female Endocervical Swab (FS)	High Sensitivity & Specificity	A: 96.3% (26/27) S: 100.0% (38/38) Total: 98.5% (64/65)	A: 99.5% (421/423) S: 99.8% (503/504) Total: 99.7% (924/927)
Female Vaginal Swab (FV)	High Sensitivity & Specificity	A: 100.0% (27/27) S: 100.0% (38/38) Total: 100.0% (65/65)	A: 98.6% (416/422) S: 99.6% (504/506) Total: 99.1% (920/928)
Female Neat Urine (FNU)	High Sensitivity & Specificity	A: 96.3% (26/27) S: 97.4% (37/38) Total: 96.9% (63/65)	A: 99.3% (420/423) S: 99.6% (503/505) Total: 99.5% (923/928)
Female Urine in Q UPT (FUPT)*	High Sensitivity & Specificity	A: 100.0% (27/27) S: 97.4% (37/38) Total: 98.5% (64/65)	A: 99.5% (421/423) S: 99.8% (504/505) Total: 99.7% (925/928)
Male Urethral Swab (MS)	High Sensitivity & Specificity	A: 100.0% (12/12) S: 100.0% (100/100) Total: 100.0% (112/112)	A: 99.2% (492/496) S: 98.7% (155/157) Total: 99.1% (647/653)
Male Neat Urine (MNU1)	High Sensitivity & Specificity	A: 100.0% (12/12) S: 100.0% (100/100) Total: 100.0% (112/112)	A: 99.2% (501/505) S: 98.1% (154/157) Total: 98.9% (655/662)
Male Urine in Q UPT (MUPT1)*	High Sensitivity & Specificity	A: 100.0% (12/12) S: 100.0% (100/100) Total: 100.0% (112/112)	A: 99.2% (501/505) S: 98.7% (155/157) Total: 99.1% (656/662)
Overall (Total)	High Sensitivity & Specificity	99.3% (592/596)	99.3% (5650/5688)

A = Asymptomatic, S = Symptomatic

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

Sample Size for Test Set:
- Female subjects: 994 (eligible)
- Male subjects: 774 (eligible)
- Total BD ProbeTec GC Q* assay results used for performance calculations: 6284
Data Provenance:
- Country of Origin: North America (seven geographically diverse clinical sites).
- Retrospective or Prospective: Prospective. The study involved collecting various specimens (endocervical swabs, male urethral swabs, vaginal swabs, and urine) from symptomatic and asymptomatic subjects.

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

Explicit details on the number of experts or their qualifications (e.g., radiologist with 10 years of experience) for establishing ground truth are not provided. The ground truth was established using an algorithm based on results from two commercially available Nucleic Acid Amplification Tests (NAATs) (the BD ProbeTec ET GC/AC assay and another commercially available NAAT). This method relies on the established performance of these reference NAATs rather than individual expert review of each case.

4. Adjudication Method for the Test Set

The adjudication method used to establish the "patient infected status" (PIS) for the ground truth was a 2-out-of-N rule (where N refers to the number of reference tests performed).

For Female subjects (endocervical swab and urine specimens): Subjects were considered infected 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)."
For Male subjects (urethral swab and urine specimens): Similar algorithm applied.
Non-infected: Subjects were considered non-infected if "less than two reference NAAT results were positive."

This implies specimens were tested by at least two reference NAATs (BD ProbeTec ET GC/AC and another commercial NAAT).

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study evaluates the performance of an assay (device) directly against a ground truth, not the comparative improvement of human readers with or without AI assistance. The device is for direct detection of N. gonorrhoeae DNA, not for aiding human interpretation of images or other data.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was performed. The BD ProbeTec GC Q* Amplified DNA Assay is a fully automated system that detects N. gonorrhoeae DNA and reports results as positive, negative, or EC failure. The performance data presented (sensitivity and specificity) is based on the algorithm's direct output compared to the established patient infected status, without human intervention in result interpretation. The "BD Viper™ System and an automated algorithm is applied to both the EC and N. gonorrhoeae -specific signals to report results."

7. Type of Ground Truth Used

The ground truth used was a composite reference standard or patient infected status (PIS) algorithm, derived from the results of two different commercially available Nucleic Acid Amplification Tests (NAATs): the BD ProbeTec ET GC/AC assay and another commercially available NAAT. It is based on the concordance of these reference molecular tests, rather than pathology (histology), expert consensus of clinical symptoms, or long-term outcomes data.

8. Sample Size for the Training Set

The document does not explicitly state a separate training set size. The clinical performance characteristics are reported from a single clinical study dataset. In diagnostic assay development, initial algorithm development and optimization might occur using internal datasets, but this document describes the validation study for regulatory submission. It's common in IVD submissions for the entire clinical study population to be used for performance evaluation against the ground truth without a separate "training set" as understood in machine learning (where the algorithm learns from the data). If an algorithm's parameters were tuned on this specific dataset, it would be a form of internal validation rather than a truly independent test set. However, the text focuses on the device's performance measurement, implying that the algorithm's parameters were fixed by the time this validation study was conducted.

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

As noted above, a separate "training set" is not explicitly mentioned. For the test set, the ground truth was established by a patient infected status (PIS) algorithm based on the concordance of two distinct commercially available NAATs (BD ProbeTec ET GC/AC assay and another commercially available NAAT) on various patient specimens.

Summary

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JUN - 5 2009

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BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay 1690971

BD Diagnostic Systems Applicant 7 Loveton Circle Sparks, MD 21152 Establishment Registration No. 1119779 Kathryn Babka Carr, RAC Contact Person tel. 410-316-4260 fax. 410-316-4041 Kathy Carr@bd.com April 3, 2009 Summary Date BD ProbeTec" Neisseria gonorrhoeae (GC) Q* Amplified Proprietary Name DNA Assay DNA probe, nucleic acid amplification, Neisseria Generic Name Classification Class II Neisseria spp. direct serological test reagents Classification Name Regulation Number 866.3390 Product Code LSL BD ProbeTec"1d Neisseria gonorrhoeae (GC) O* Amplified Predicate Devices DNA Assay (K081825) Gen-Probe Amplified Neisseria gonorrhoeae Assay (K043144) Device Description

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

Intended Use

The BD ProbeTec"11 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 and male individuals to aid in the diagnosis of gonococcal urogenital disease.

Clinical Performance Characteristics

Clinician-collected endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female Or UPT and neat urine specimens were collected from 1059 symptomatic and asymptomatic female subjects and 787 symptomatic and asymptomatic 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 13 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 774 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 774 eligible male subjects. Up to three randomized urethral swab specimens were collected followed by a urine specimen that was split into O UPT, neat urine and the two reference urine specimen collection devices.

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

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 urine specimen results from the commercially available BD ProbeTec ET GC/AC assay and the other commercially available NAAT. Subjects were considered infected 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 6284 BD ProbeTec GC Q* assay results from symptomatic female and male were 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)

			Performance Compared to Patient InfectedStatus
SpecimenType	Symptomatic	N	Sensitivity	95%C.I.	Specificity	95%C.I.	PPV	NPV	ErrorInitial/Final
FS	A	450	96.3%(26/27)	(81.0% -99.9%)	99.5%(421/423)	(98.3% -99.9%)	92.5%	99.8%	3/0
	S	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%)	95.9%	99.9%	5/2
FV	A	449	100.0%(27/27)	(87.2% -100.0%)	98.6%(416/422)	(96.9% -99.5%)	82.0%	100.0%	0/0
	S	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%)	88.5%	100.0%	0/0
FNU	A	450	96.3%(26/27)	(81.0% -99.9%)	99.3%(420/423)	(97.9% -99.9%)	89.8%	99.8%	0/0
	S	543	97.4%(37/38)	(86.2% -99.9%)	99.6%(503/505)	(98.6% -100.0%)	94.8%	99.8%	0/0
	Total	993	96.9%(63/65)	(89.3% -99.6%)	99.5%(923/928)	(98.7% -99.8%)	93.1%	99.8%	0/0
FUPT	A	450	100.0%(27/27)	(87.2% -100.0%)	99.5%(421/423)	(98.3% -99.9%)	92.7%	100.0%	0/0
	S	543	97.4%(37/38)	(86.2% -99.9%)	99.8%(504/505)	(98.9% -100.0%)	97.3%	99.8%	0/0
	Total	993	98.5%(64/65)	(91.7% -100.0%)	99.7%(925/928)	(99.1% -99.9%)	95.8%	99.9%	0/0
MS	A	508	100.0%(12/12)	(73.5% -100.0%)	99.2%(492/496)	(97.9% -99.8%)	75.5%	100.0%	0/0
	S	257	100.0%(100/100)	(96.4% -100.0%)	98.7%(155/157)	(95.5% -99.8%)	98.0%	100.0%	1/0
	Total	765	100.0%(112/112)	(96.8% -100.0%)	99.1%(647/653)	(98.0% -99.7%)	95.0%	100.0%	1/0
SpecimenType	Symptomatic	N	Sensitivity	95%C.I.	Specificity	95%C.I.	PPV	NPV	ErrorInitial/Final
MNU1	A	517	100.0%(12/12)	(73.5% -100.0%)	99.2%(501/505)	(98.0% -99.8%)	74.6%	100.0%	0/0
MNU1	S	257	100.0%(100/100)	(96.4% -100.0%)	98.1%(154/157)	(94.5% -99.6%)	97.1%	100.0%	0/0
MNU1	Total	774	100.0%(112/112)	(96.8% -100.0%)	98.9%(655/662)	(97.8% -99.6%)	93.9%	100.0%	0/0
MUPT1	A	517	100.0%(12/12)	(73.5% -100.0%)	99.2%(501/505)	(98.0% -99.8%)	74.6%	100.0%	1/0
MUPT1	S	257	100.0%(100/100)	(96.4% -100.0%)	98.7%(155/157)	(95.5% -99.8%)	98.0%	100.0%	0/0
MUPT1	Total	774	100.0%(112/112)	(96.8% -100.0%)	99.1%(656/662)	(98.0% -99.7%)	95.0%	100.0%	1/0
Total		6284	99.3%(592/596)	(98.3% -99.8%)	99.3%(5650/5688)	(99.1% -99.5%)	93.7%	99.9%	7/2

1 Clinical Trial enrollment for asymptomatic male subjects was extended to obtain the total number of clinical positives for this sub-population.

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

Asymptomalic Chi
Film
Fürft Confidence Interval Female Neat Urine
Female endocervical swab Female urine in Q* UPT FV
MNU Female vaginal swab r omato vaginal Swas
Male urethral swab
Male urethrall swab
Male urine in Q* UPT
number MS
MUPT ហ S Symptomatic

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

A total of 6284 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/5/Figure/4 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 bold, sans-serif font.

Image /page/5/Figure/5 description: The image is a bar graph that shows the frequency of MaxRFU values. The x-axis represents the MaxRFU ranges, and the y-axis represents the frequency. The highest frequency is in the 0-49 range, with a value of 5636. The frequency for >=800 is 617.

Conclusions

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN - 5 2009

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

K090971 Re:

Trade/Device Name: BD Probetec ™ Nesseria gonorrhoeae (GC) Qx Amplified DNA Assay

Regulation Number: 21 CFR 866.3390 Regulation Name: Nesseria spp. Direct serological test reagents Regulatory Class: Class II Product Code: LSL Dated: April 3, 2009 Received: April 6, 2009

Dear Ms. 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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Page 2 -

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 vours,

Sally attapra

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

60999971 510(k) Number (if known):

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)

Vhe Schef

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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609 0971 ੋ 1 ਨੇ 1 ਨੇ 1 2 ਮਾਰ

BD Diagnostic Systems Becton, Dickinson and Company

Page vi

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).