The BD ProbeTec ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Amplified DNA Assays, when tested with the BD ProbeTec 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. gonorrhoege, or of co-infection with both C. trachomatis and N. gonorrhoege. Specimens may be from symptomatic or asymptomatic females and males. A separate Amplification Control is an option for inhibition testing (BD ProbeTec ET CT/GC/AC Reagent Pack). The BD ProbeTec ET CT/GC assays may be performed using either the BD ProbeTec ET System or a combination of the BD ProbeTec ET System and BD Viper instrument.

The BD Viper System, when used with BD ProbeTec™ ET amplified nucleic acid assays, 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 ET CT/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 DNA in clinical specimens.

The BD Viper System is comprised of a standalone lysing heater and a BD Viper Instrument. The BD Viper Instrument is comprised of five major subsystems: robotic pipetting arm, priming and warming heaters (two sets), liquid crystal display (LCD) monitor with touch screen, instrument software and two thermally controlled fluorescent readers.

AI/ML Overview

The provided text describes the BD Viper™ System, a modification of existing devices (BD ProbeTec™ ET System and BD Viper™ Instrument) used for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) DNA. The 510(k) summary explains that the modifications did not introduce new issues of safety or effectiveness and that the system met acceptance criteria across various parameters.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

Parameter	Acceptance Criteria	Reported Device Performance
Lysing Heater	Meet operating specifications across various environmental conditions.	The BD Viper System met operating specifications across various environmental conditions.
Optical Linearity	Meet optical and linearity specifications.	The BD Viper System met optical and linearity specifications.
Hardware Environmental	Meet thermal, pipetting, and optical specifications across various environmental conditions.	The BD Viper System met thermal, pipetting, and optical specifications across various environmental conditions.
Instrument Contamination	Meet specifications with regard to control and experimental conditions.	The BD Viper System met specifications with regard to control and experimental conditions.
System Environmental	Meet expected results with BD ProbeTec ET CT/GC controls across various environmental conditions.	The BD Viper System met expected results with BD ProbeTec ET CT/GC controls (i.e., positive, negative) across various environmental conditions.
Analytical Limit of Detection (Diluent)	Have an equivalent analytical limit of detection to the BD ProbeTec ET System for both CT and GC assays in a clean system matrix.	The BD Viper System had an equivalent analytical limit of detection to the BD ProbeTec ET System for both the BD ProbeTec ET CT and GC assays in a clean system matrix (i.e., BD ProbeTec ET diluent).
Precision	Be established and meet expected results (positive, negative) for the BD ProbeTec ET CT/GC assays.	The precision of the BD Viper instrument was established and met expected results (i.e. positive, negative) for the BD ProbeTec ET CT/GC assays.
Analytical Limit of Detection (Clinical Matrices)	Have an equivalent analytical limit of detection to the BD ProbeTec ET System for both CT and GC assays in clinical matrices.	The BD Viper System had an equivalent analytical limit of detection to the BD ProbeTec ET System for both BD ProbeTec ET CT/GC assays in clinical matrices.
Individual Spiked Specimen	Meet expected results (positive, negative) for the BD ProbeTec ET CT/GC assays.	The BD Viper System met expected results (i.e., positive, negative) for the BD ProbeTec ET CT/GC assays.
Clinical Agreement	Show equivalent performance between the BD Viper System and the BD ProbeTec ET System for the BD ProbeTec ET CT/GC assay.	The BD ProbeTec ET CT/GC assay performance was equivalent between the BD Viper System and the BD ProbeTec ET System.

Study Details for Device Performance Evaluation

The study described is a comparison of the modified BD Viper System to the predicate BD ProbeTec ET System or to expected results through spiked specimen studies. The BD ProbeTec ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Amplified DNA Assays were used for clinical performance evaluation.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify the exact sample size for the clinical test set. It mentions "clinical matrices" for the Analytical Limit of Detection and "Clinical Agreement" studies, but without specific numbers.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the text. The methods described are laboratory-based comparisons and spiked specimen studies, typical for molecular diagnostic device evaluations. There is no mention of "experts" establishing ground truth in the context of diagnostic interpretation.
Adjudication method for the test set:
- This information is not applicable and therefore not provided, as the studies involve direct comparison of analytical detection capabilities and system performance with a predicate device or spiked samples, not human interpretation requiring adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not conducted. This applies to diagnostic imaging devices where human interpretation is involved. The BD Viper System is an automated molecular diagnostic platform.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the studies described are inherently standalone performance evaluations. The device's analytical capabilities (e.g., limit of detection, precision, instrument contamination, clinical agreement with a predicate system) were assessed without human-in-the-loop performance measurement. The system is an automated diagnostic instrument.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For analytical performance (e.g., limit of detection, precision, instrument contamination), the ground truth was established by known concentrations of target DNA (spiked specimens) or known positive/negative controls.
- For clinical agreement, the ground truth was essentially the results obtained from the legally marketed predicate device (BD ProbeTec ET System), as the study aimed to show equivalence.
The sample size for the training set:
- This information is not applicable as the BD Viper System is a molecular diagnostic instrument, not an AI or machine learning model that requires a "training set" in the conventional sense. The "training" in this context refers to the development and optimization of the instrument's components and assays, rather than an algorithmic training phase with labeled data.
How the ground truth for the training set was established:
- This information is not applicable for the reasons stated above. The system's design and optimization would rely on engineering principles, analytical chemistry, and molecular biology, validated through rigorous testing against known standards and the predicate device.

Summary

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510(k) SUMMARY

SUBMITTED BY:	BECTON, DICKINSON AND COMPANY7 LOVETON CIRCLESPARKS, MD 21152
CONTACT NAME:	Colleen A. Kistler
TELEPHONE:	410-316-4988
PREPARED:	September 8, 2005
DEVICE NAME:	BD ProbeTec™ ET Chlamydia trachomatis andNeisseria gonorrhoeae Amplified DNA Assays
	BD Viper™ System
PREDICATE DEVICES:	BD ProbeTec™ ET System as cleared with the BDProbeTec™ ET Chlamydia trachomatis andNeisseria gonorrhoeae Amplified DNA Assays(K984631)
	BD Viper™ Instrument (K023955)

INTENDED USE:

The BD ProbeTec ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Amplified DNA Assays, when tested with the BD ProbeTec ET System, use Strand Annumbed Driver List in List of the direct, qualitative detect, qualitative detection of Displacement inspiritional 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 both C. trachomatis and N. il denomans, ... gonorrhoemay be from symptomatic or asymptomatic females and males. generate Amplification Control is an option for inhibition testing (BD ProbeTec ET A separato Ampilliedaton Solla ProbeTec ET CT/GC assays may be performed using either the BD ProbeTec ET System or a combination of the BD ProbeTec ET System and BD Viper instrument.

The BD Viper System, when used with BD ProbeTec™ ET 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).

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DEVICE DESCRIPTION:

SUBSTANTIAL EQUIVALENCE:

This Special 510(k) is submitted for modifications to the subsystems previously cleared with the BD ProbeTec ET System (K984631) and the BD Viper Instrument (K023955). The BD Viper System is comprised of a standalone lysing heater and a BD Viper Instrument that combines the thermal, pipetting and optical subsystems from the previously cleared devices. Thus, there is no technology or intended use change associated with the device modification.

Modifications to the subsystems previously cleared with the BD ProbeTec ET System and BD Viper Instrument are as follows:

Modification	Potential Impact of Modification
Incorporated upgraded robot arm andcontroller	Hardware, Pipettor, Software
Lysing Heater and Lysing Rack dimensionsmodified to accommodate tube spacing onthe BD Viper Instrument	Hardware, Thermal. Clinical Performance
Two BD ProbeTec ET thermally controlledoptical reader assemblies repackaged andincorporated into the BD Viper Instrument	Hardware, Optics, Thermal, Software,Clinical Performance
Single function warming heater replacedwith a dual-function reader subsystem	Hardware, Thermal, Software, ClinicalPerformance
Processing/Workflow Modifications	Pipettor, Hardware, Software, ClinicalPerformance
User Software Modifications	Software

The risk analysis did not identify these changes as raising new issues of safety and effectiveness. The parameters listed below were evaluated in studies comparing the BD Viper System to the BD ProbeTec ET System or to expected results (spiked specimen studies). The BD ProbeTec ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Amplified DNA Assays were used to evaluate clinical performance. The BD Viper System met acceptance criteria for all parameters.

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Parameter	Result
Lysing Heater	The BD Viper System met operatingspecifications across various environmentalconditions.
Optical Linearity	The BD Viper System met optical andlinearity specifications.
Hardware Environmental	The BD Viper System met thermal,pipetting, and optical specifications acrossvarious environmental conditions.
Instrument Contamination	The BD Viper System met specificationswith regard to control and experimentalconditions.
System Environmental	The BD Viper System met expected resultswith BD ProbeTec ET CT/GC controls(i.e., positive, negative) across variousenvironmental conditions.
Analytical Limit of Detection (Diluent)	The BD Viper System had an equivalentanalytical limit of detection to the BDProbeTec ET System for both the BDProbeTec ET CT and GC assays in a cleansystem matrix (i.e., BD ProbeTec ETdiluent).
Precision	The precision of the BD Viper instrumentwas established and met expected results(i.e. positive, negative) for the BDProbeTec ET CT/GC assays.
Analytical Limit of Detection (ClinicalMatrices)	The BD Viper System had an equivalentanalytical limit of detection to the BDProbeTec ET System for both BDProbeTec ET CT/GC assays in clinicalmatrices.
Individual Spiked Specimen	The BD Viper System met expected results(i.e., positive, negative) for the BDProbeTec ET CT/GC assays.
Clinical Agreement	The BD ProbeTec ET CT/GC assayperformance was equivalent between theBD Viper System and the BD ProbeTec ETSystem.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is simple and recognizable, representing the department's role in promoting the health and well-being of the nation.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 2 5 2005

Ms. Colleen A Kistler Regulatory Affairs Specialist BD Diagnostic Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152

Re: K052481

Trade/Device Name: BD Viper™ System Regulation Number: 21 CFR 866.3390 Regulation Name: Neisseria spp. direct serological test reagents Regulatory Class: Class II Product Code: LSL Dated: November 15, 2005 Received: November 16, 2005

Dear Ms. Kistler:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the endrosals) to ttgrains and ment date of the Medical Device Amendments, or to conninered pror co rize) 2011-12-11 accordance with the provisions of the Federal Food, Drug, de nees that have occir rout 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 I ou may, therefore, mains 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 that + Dr haral statutes and regulations administered by other Federal agencies. You must or any I 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 predicated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, rr you stions on the promotion and advertising of your device, please contact the Office of In of quotions of the prom Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sale, a Story

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 (if known):

Kosa481

Device Name: BD ProbeTec™ ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Amplified DNA Assays

BD Viper™ System

Indications For Use:

The BD ProbeTec ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Amplified DNA Assays, when tested with the BD ProbeTec 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 both C. trachomatis and N. gonorrhoege. Specimens may be from symptomatic or asymptomatic females and males. A separate Amplification Control is an option for inhibition testing (BD ProbeTec ET CT/GC/AC Reagent Pack). The BD ProbeTec ET CT/GC assays may be performed using either the BD ProbeTec ET System or a combination of the BD ProbeTec ET System and BD Viper instrument.

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)

Allie Sati

Division Sign-Off

Page 1 of 1

BD Diagnostic Systems Becton, Dickinson and Company Office of In Vitro Diagnostic Device

510(k) K052481

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).