BD PROBE TEC URINE PRESERVATIVE TRANSPORT

K052224 · Becton, Dickinson & CO · LSL · Sep 12, 2005 · Microbiology

Device Facts

• Record ID: K052224
• Device Name: BD PROBE TEC URINE PRESERVATIVE TRANSPORT
• Applicant: Becton, Dickinson & CO
• Product Code: LSL · Microbiology
• Decision Date: Sep 12, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3390
• Device Class: Class 2

Intended Use

The intended use of the BD ProbeTec ET CT/GC Amplified DNA Assays is unchanged.

Device Story

The BD ProbeTec ET system uses Strand Displacement Amplification (SDA) and fluorescent energy transfer (ET) to detect C. trachomatis and N. gonorrhoeae DNA in clinical specimens. The Urine Preservative Transport (UPT) kit, containing NAP Guard (K2EDTA), preserves urine samples for transport to testing sites. The system is operated by laboratory personnel. The device processes samples to provide qualitative results, which assist clinicians in diagnosing infections. The modification adds neat urine as a sample type and updates the UPT device materials and workflow. These changes aim to maintain or improve sensitivity and specimen stability compared to the predicate.

Clinical Evidence

Bench testing only. Comparison data provided for CT and GC assay results between the modified urine processing method and the predicate method to demonstrate equivalent performance.

Technological Characteristics

Uses homogeneous Strand Displacement Amplification (SDA) and fluorescent energy transfer (ET). UPT kit contains 50 µL of NAP Guard (742.5 mM K2EDTA) and a disposable transfer pipette. System is compatible with BD ProbeTec ET and BD Viper instruments. Connectivity is not specified. Sterilization method not stated.

Indications for Use

Indicated for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) DNA in clinical specimens.

Regulatory Classification

Identification

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

Predicate Devices

• BD ProbeTec™ Urine Processing Pouch (UPP) Kit as cleared with the BD ProbeTec ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Amplified DNA Assays (K984631)

Submission Summary (Full Text)

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K os224

# 510(k) SUMMARY

| SUBMITTED BY: | BECTON, DICKINSON AND COMPANY<br>7 LOVETON CIRCLE<br>SPARKS, MD 21152 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT:<br>TELEPHONE: | KATHRYN BABKA POWERS<br>[phone] |
| PREPARED: | September 7, 2005 |
| DEVICE NAME: | BD ProbeTec™ ET Chlamydia trachomatis and Neisseria gonorrhoeae<br>Amplified DNA Assays<br><br>BD ProbeTec™ Urine Preservative Transport (UPT) |
| PREDICATE<br>DEVICE: | BD ProbeTec™ Urine Processing Pouch (UPP) Kit as cleared with the BD<br>ProbeTec ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC)<br>Amplified DNA Assays (K984631) |

## INTENDED USE:

The BD ProbeTec™ ET Chlamydia trachomatis and Neisseria governhoeae Amplified DNA The BD Probe Lec - ET Chiamyan Irachomans and Probections of Strand Displacement Ampilification Assays, when tested with the BD Froberted LT System, accommia trachomatis and Neisseria
(SDA) technology for the direct, qualitative detection of Chiamydia and male wrine (SDA) technology for the direct, qualitan's actorien of swabs, and in female and male urines, gonorrhoeae DNA in endocervical swars, marc arean and N. gonomoneer of oo infection with specimens as evidence of miection with C. ruchomans and en genesymptomatic and asymptomatic
both C. trachomatis and N. gonorroheae. Specimens may be from for the fina (BD both C. trachomans and M. gonorroneac. Open of in is an option for inhibition testing (BD)
females and males. A separate Amplification Donator Andress of CC occave may be per females and males. A separate Ampilitation Control is an of CT/GC assays may be performed ProbeTec ET CT/GC/AC Reagent Pack). The DD FrobeTee BT OF OF Street of System and the BD Viper™ instrument.

The BD ProbeTec™ Urine Preservative Transport Kit with NAP Guard™ technology is designed to The BD Probe lec" - Orme Preselvative Transport Kit Will a gonorrhoeae in male and female with the preserve and transport Chianyalu fractionalis and individuals prior to processing for analysis with the specimens from symplomatic and asymptomatic marriadal (GC) Amplified DNA Assays.

## DEVICE DESCRIPTION:

The BD ProbeTec ET CT/GC amplified DNA assays utilize homogeneous SDA technology as the The BD Probe lec ET CT/CC ampillica DNA assays annot mores.
amplification method and fluorescent energy transfer (ET) as the detection method to test for the presence of CT and GC in clinical specimens.

The BD ProbeTec Urine Preservative Transport Kit with NAP Guard technology allows for an The BD Probe Lec Urine Preselvative Transport the with a storage and transport when testing extended range of time and telliperature concirculare in urine specimens using the for the presence of Chiangan muchomans and reason. Each UPT ontains 50 µL of NAP Guard (2
BD ProbeTec ET CT and GC Amplified DNA Assays. Each UPT ontains to the UPT 742.5 mM K2EDTA) packaged with a disposable transfer pipette. Urine is transferred to the UPT
742.5 mM K2EDTA) packaged with a disposable transfer pipette. Urine as transferr 742.5 mM K2EDTA) packaged with a disposable fransite pipettor - seen
tube, mixed with the tube contents and transported to the test site for processing according to the assay package insert.

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# SUBSTANTIAL EQUIVALENCE:

This Special 510(k) is submitted for modifications to the BD ProbeTec Urine Processing Pouch This Special 510(k) is submitted ID Inounceanons of the works (CT) and Neisseria
(UPP) originally cleared with the BD ProbeTect 1000121) | The RD ProbeTec (UPP) originally cleared with the BD F100E ICC Chination includited device, the BD ProbeTec gonorrhoeae (GC) Amplified DNA Assay (C994031). The Inounled cornely arme specimens from
Urine Preservative Transport (UPT) is intel to the PD Probec FFC CT/AC Assays. No Urine Preservative Transport (OF I J IS Intended on testing with the BD ProbeTec ET CT/GC Assays. No
symptomatic or asymptomatic individuals in test CT/CT/GC Assays No symptomatic or asymptomatic individuals for testing with the BD ProbeTec ET CT/GC Amplified DNA Assays as a
changes in intended use are being made to the BD ProbeTec ET CT/GC result of this modification.

Also included in this Special 510(k) is the addition of neat urine without preservative) as a Also included in this Special 310(K) is the addition of the UPP device in the UPP device in that, under sample type with the CT/GC assays. Neat units and with a modification to the specimen processing.
restricted urine transport and storage conditions and with a mecimen process restricted urine transport and storage continues and with a mosted in the specimen processing procedure.

Modifications of the UPP device are as follows:

| Modification | Potential Impact of Modification |
|-----------------------------------|----------------------------------|
| Materials Modification | Specimen Stability |
| Input Specimen Volume Requirement | Sensitivity |
| Processing/Workflow Modification | Assay Interference |

Risk analysis did not identify the changes as raising new issues of safety and effectiveness. The Risk and your were evaluated in comparison studies of the UPT device and Neat urine mat readyet class parameters listed below were evaluated in comparison stacted of the sample type met product claims for all parameters.

| Parameter | Result |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Analytical Limit of Detection | UPT and Neat urine sample types have<br>analytical limits of detection equivalent to or<br>better than UPP. |
| Interfering Substances | Potential interferents have no significant<br>impact to positive and negative assay results<br>with UPT and Neat urine sample types. |
| Specimen Stability | UPT specimen stability exceeds UPP specimen<br>stability.<br>Neat urine specimen stability is established. |
| Clinical Performance | UPT and Neat urine performance<br>characteristics are equivalent to UPP. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure embracing a sphere, which symbolizes the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.

SEP 1 2 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K052224

. K032224
Trade/Device Name: BD ProbeTec™ ET CT/GC Amplified DNA Assays Regulation Number: 21 CFR 866.3390 Regulation Name: Neisseria spp. direct serological test reagents Regulatory Class: Class II Product Code: LSL, MKZ Dated: August 15, 2005 Received: August 16, 2005

Dear Ms. Powers:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave a rowe 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sale, a Tory

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): K052224

Device Name: BD ProbeTec™ ET Chlamydia trachomatis and Neisseria gonorrohoeae Amplified DNA Assays

#### Indications For Use:

The BD ProbeTec™ ET Chlamydia trachomatis and Neisseria gonorrohoeae The BD ProbeTec - when tested with the BD ProbeTec ET System, uses Amplifica Driver Association (SDA) technology for the direct, qualitative Strand Displacementis and Neisseria gonorrhoeae DNA in ucceenon of Chiamyana wabs, and in female and male urine specimens chaoce vical swably ma with C. trachomatis and N. gonorroheae, or of coas Cvidence of Infoction with entis and N. gonorroheae. Specimens may be from symptomatic and asymptomatic females and males. A separate Amplification Symptomation and abythr inhibition testing (BD ProbeTec ET CT/GC/AC Reagent Control to an option to ET CT/GC assays may be performed using either the I ack). The BD Frooten or a combination of the BD ProbeTec ET System and the BD Viper™ instrument.

V Prescription Use (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)

Fuddli L. Poole

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K052234