The BDProbeTec™ ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays, when tested with the BDProbeTec™ ET System, use Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical swabs, male urethral swabs, and in female and male urine specimens as evidence of infection with C. trachomatis, N. gonorrhoeae, or of co-infection with C. trachomatis and N. gonorrhoeae. Specimens may be from symptomatic or asymptomatic males and females. A separate Amplification Control is an option for inhibition testing (BDProbeTec™ ET CT/GC/AC Reagent Pack).

Device Description

The BDProbeTecTM ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) amplified DNA assays utilize homogeneous SDA technology as the amplification method and fluorescent energy transfer (ET) as the detection method to test for the presence of CT and GC in clinical specimens.

For each assay, the SDA reagents are dried in two separate microwell strips. First, the processed sample is added to the Priming Microwell which contains the amplification primers, fluorescent labeled detector probe, and other reagents necessary for amplification. However, because no enzymes are present in the priming microwell strips, no amplification occurs at this step. After incubation, the reaction mixture is transferred to the Amplification Microwell, which contains two enzymes (a DNA polymerase and a restriction endonuclease) necessary for SDA. It is in this latter microwell in which amplification and detection occurs. The Amplification Microwells are sealed to prevent contamination and then incubated in a thermally controlled fluorescent reader which monitors each test well for the generation of amplified products. The presence or absence of CT and GC is determined by relating the BDProbeTec™ ET MOTA (Method Other Than Acceleration) scores for the sample to pre-determined cutoff values. The MOTA score is a metric used to assess the magnitude of signal generated as a result of the reaction.

If the CT/GC Reagent Pack is used, each sample and control are tested in two discrete microwells: C. trachomatis and N. gonorrhoeae. Results are reported through an algorithm as positive or negative. If the CT/GC/AC Reagent Pack is used, each sample and control are tested in three discrete microwells: C. trachomatis, N. gonorrhoeae, and the Amplification Control. The purpose of the Amplification Control is to identify a sample that may inhibit the SDA reaction. Results are reported through an algorithm as positive, negative, or indeterminate.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the BDProbeTec™ ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary focuses specifically on the Neisseria gonorrhoeae (GC) assay for asymptomatic males, comparing it to culture methods and a predicate device (Abbott LCx® N. gonorrhoeae assay). While explicit "acceptance criteria" are not listed numerically in the same way modern regulatory submissions often delineate them, the summary presents the performance metrics that were deemed sufficient for "substantial equivalence."

Metric	Acceptance Criteria (Implied)	Reported Device Performance (Asymptomatic Male)	Specimen Type
Sensitivity	Sufficient for Substantial Equivalence	95.5%	Urethral Swabs
Sensitivity	Sufficient for Substantial Equivalence	100%	Male Urines
Specificity	Sufficient for Substantial Equivalence	99.4%	Urethral Swabs
Specificity	Sufficient for Substantial Equivalence	99.5%	Male Urines

Note: The document states the results were "substantially equivalent" to GC culture methods and the Abbott LCx® assay, implying these performance values met the threshold for that determination.

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

The study was a multicenter study, indicating data from various geographical locations in the US. It was a retrospective and prospective study, as it first describes an initial multicenter study and then a supplementary study to gather more asymptomatic male GC data, which was then "pooled."

Initial Multicenter Study:
- 2109 patients
- 4108 C. trachomatis (CT) specimens
- 4105 N. gonorrhoeae (GC) specimens
- Collected from seven geographically diverse clinical sites (e.g., sexually transmitted disease clinics, OB/GYN clinics, family planning clinics, adolescent clinics, emergency rooms).
- Included 183 asymptomatic male GC swab specimens.
- Included 184 asymptomatic male GC urine specimens.
Supplementary Study (Asymptomatic Male GC Data):
- 519 patients
- 987 specimens (asymptomatic male urethral swab and urine specimens)
- Conducted at three clinical sites (one of which participated in the original evaluation).
- Results were pooled with the original study's asymptomatic male GC specimens.

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

The document does not explicitly state the number or qualifications of experts involved in establishing the ground truth. However, the ground truth for N. gonorrhoeae in the study was based on:

Culture: This implies laboratory personnel with expertise in microbiological culture techniques would have performed and interpreted these assays.
Patient Infected Status (GC Culture): This indicates that a positive GC culture was the determinant of infection for comparing the BDProbeTec™ ET assay.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for conflicting results between the investigational device and the ground truth. The comparison was reported as direct sensitivity and specificity against the established ground truth (culture or patient infected status based on culture).

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is for an in vitro diagnostic (IVD) device, not an imaging device typically evaluated with MRMC studies. The device is for direct detection of DNA, and its performance is assessed against a gold standard, not by human reader interpretation.

6. Standalone Performance

Yes, a standalone performance study was done. The reported sensitivity and specificity values (95.5%, 100%, 99.4%, 99.5%) represent the unaided, algorithm-only performance of the BDProbeTec™ ET assay compared to the ground truth. There is no human-in-the-loop component mentioned in these performance metrics.

7. Type of Ground Truth Used

The ground truth used for N. gonorrhoeae was:

Culture: For comparing the BDProbeTec™ ET GC assay to traditional methods.
Patient Infected Status (defined as a positive GC culture): This was the primary definition of infection used to calculate sensitivity and specificity for the BDProbeTec™ ET assay.

8. Sample Size for the Training Set

The document does not provide a separate sample size for a "training set." The performance data presented (sensitivity and specificity) is from the clinical studies described, which would typically be considered the "test set" for regulatory submission. It's possible that internal development and optimization used other data, but that is not detailed in this 510(k) summary.

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

Since a separate training set is not explicitly detailed, the method for establishing ground truth for the clinical studies (which act as the definitive test set here) was based on GC culture as described above.

Summary

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K012351

SEP 1 8 2001

510(k) SUMMARY

SUBMITTED BY: BECTON, DICKINSON AND COMPANY 7 LOVETON CIRCLE SPARKS, MD 21152
Colleen Rohrbeck, Regulatory Affairs Specialist CONTACT:

(410) 316-4988 TELEPHONE:

July 24, 2001 PREPARED:

BDProbeTec™ ET Chlamydia trachomatis and Neisseria DEVICE NAME: gonorrhoeae Amplified DNA Assays

PREDICATE

Neisseria gonorrhoeae culture DEVICES: Abbott LCx® Neisseria gonorrhoeae Assay

INTENDED USE: The BDProbeTec™ ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays, when tested with the BDProbeTec™ ET System, use Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical swabs, male urethral swabs, and in female and male urine specimens as evidence of infection with C. trachomatis, N. gonorrhoeae, or of co-infection with C. trachomatis and N. gonorrhoeae. Specimens may be from symptomatic or asymptomatic males and females. A separate Amplification Control is an option for inhibition testing (BDProbeTec™ ET CT/GC/AC Reagent Pack).

DEVICE DESCRIPTION:

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present in the priming microwell strips, no amplification occurs at this step. After incubation, the reaction mixture is transferred to the Amplification Microwell, which contains two enzymes (a DNA polymerase and a restriction endonuclease) necessary for SDA. It is in this latter microwell in which amplification and detection occurs. The Amplification Microwells are sealed to prevent contamination and then incubated in a thermally controlled fluorescent reader which monitors each test well for the generation of amplified products. The presence or absence of CT and GC is determined by relating the BDProbeTec™ ET MOTA (Method Other Than Acceleration) scores for the sample to pre-determined cutoff values. The MOTA score is a metric used to assess the magnitude of signal generated as a result of the reaction.

DEVICE COMPARISON:

The BDProbeTec™ ET GC assay is similar to culture methods in that:

Both assays detect N. gonorrhoeae .
Both assays detect N. gonorrhoeae in endocervical and urethral swabs and . male and female urine specimens

The BDProbeTec™ ET GC assay differs from culture methods in that:

The BDProbeTec™ ET GC assay detects DNA of the N. gonorrhoeae . organism while culture methods detect the whole living organism
The BDProbeTec™ ET GC assay can provide results in one hour while . culture methods can take up to 72 hours

The BDProbeTec™ ET GC assay is similar to the Abbott LCx® N. gonorrhoeae assay in that:

Both assays utilize nucleic acid amplification technology .
Both assays have the same intended use .
Both assays detect N. gonorrhoeae from endocervical and urethral swabs . and male and female urine specimens
. Both assays can test specimens from symptomatic and asymptomatic patients
Both assays are qualitative .

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The BDProbeTec™ ET GC assay differs from the Abbott LCx® N. gonorrhoeae assay in that:

The BDProbeTec™ ET GC assay uses SDA technology while LCR . technology is used for the Abbott LCx® N. gonorrhoeae assay
The BDProbeTec™ ET GC assay uses simultaneous amplification/detection o while the Abbott LCx® N. gonorrhoeae assay uses amplification followed by detection
The BDProbeTec™ ET GC assay can be performed in one room while the � Abbott LCx® N. gonorrhoeae assay requires separate sample processing and amplification/detection areas (i.e. unidirectional workflow)
The BDProbeTec™ ET GC assay utilizes a dried reagent format while the � Abbott LCx® N. gonorrhoeae assay utilizes liquid reagents
The BDProbeTec™ ET GC assay has an amplification control to monitor for 0 inhibition while the Abbott LCx® N. gonorrhoeae assay does not have an amplification control

SUMMARY OF PERFORMANCE DATA:

CLINICAL STUDIES:

Performance characteristics for the BDProbeTec™ ET CT and GC Amplified DNA Assays were initially established in a multicenter study at seven geographically diverse clinical sites. The final data analysis included 4108 CT and 4105 GC specimens collected from 2109 patients attending sexually transmitted disease clinics, OB/GYN clinics, family planning clinics, adolescent clinics, and emergency rooms. In this study, the seven sites collected 183 and 184 asymptomatic male GC swab and urine specimens, respectively.

To supplement the asymptomatic male GC data, a similar study was conducted at three clinical sites: one of which participated in the original evaluation. The study included collecting asymptomatic male urethral swab and urine specimens. A total of 987 specimens collected from 519 patients were used in the data analysis. Results were pooled with the specimens collected in the original study.

BDProbeTec™ ET N. gonorrohoeae results were compared to culture and patient infected status (for this study, patient infected status was defined as a patient with a positive GC culture). Sensitivity for asymptomatic male urethral swabs and male urines was 95.5% and 100%, respectively. Specificity for asymptomatic male urethral swabs and male urines was 99.4% and 99.5%, respectively.

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The BDProbeTec™ ET Neisseria gonorrhoeae results in an asymptomatic male population are substantially equivalent' to GC culture methods that were in use prior to May 28, 1976 and to the Abbott LCx ® Neisseria gonorrhoeae Assay.

1 The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence as found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's commitment to health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 8 2001

Ms. Colleen Rohrbeck Regulatory Affairs Specialist Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152

K012351 Re:

Trade/Device Name: BDProbeTec™ ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays Regulation Number: 21 CFR 866.3390, 866.3120 Regulation Name: Neisseria spp. Direct serological test reagents, Chlamydia serological reagents. Regulatory Class: II Product Code: LSL, MKZ Dated: July 24, 2001 Received: July 25, 2001

Dear Ms. Rohrbeck:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 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 and v additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1_of 1

510(k) Number (if known): K 0/ 2 35 /

Device Name: BDProbeTec™ ET Chlamydia trachomatis and Neisseria_ gonorrhoeae Amplified DNA Assays

Indications for Use:

The BDProbeTec™ ET Chlamydia trachomatis and Neisseria gonorrhoeae The DDFrobeTec - ET Onlamyala trachern - Recomments
Amplified DNA Assays, when tested with the BDProbeTec™ ET System, use Strand Amplification Assuys, which toology for the direct, qualitative detection of Displacement Ampillioution (US) (Seria gonorrhoeae DNA in endocervical swabs, Onlantyala trachomatio and in female and male urine specimens as evidence of male urethith Swabo, and tis, N. gonorrhoeae, or of co-infection with both intection will O. trachomatis, A. Specimens may be from symptomatic or O. Itachomatic females and males. A separate Amplification Control is an option for asymptomation tomation and Tec™ ET CT/GC/AC Reagent Pack).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Freddie Laker

(Division Sian-Off) Division of Clinical Laboratory Devices

510(k) Number-

(Optional Format 3-10-98)

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).