BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY

• K Number: K090824
• Device Name: BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
• Manufacturer: BECTON, DICKINSON & CO.
• Date Cleared: 2009-06-02 ( 68 days)
• Product Code: MKZ
• Regulation Number: 866.3120

Intended Use

The BD ProbeTec™ Chlamydia trachomatis (CT) 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 Chlamydia trachomatis 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 also intended for use with gynecological specimens collected in PreservCyt® Solution using an aliquot that is removed prior to processing for additional gynecological testing. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial 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 CT Q* Amplified DNA Assay is based on the simultaneous amplification and detection of target DNA using amplification primers and a fluorescently-labeled detector probe (8, 9). 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 thermally-controlled fluorescent readers. The presence or absence of C. trachomatis 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 C. trachomatis 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 C. trachomatisspecific 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 C. trachomatis-specific signals to report results as positive, negative, or EC failure.

Predicate Devices

K081824, K053446

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard molecular diagnostic techniques (SDA, fluorescence detection) and a simple automated algorithm for result interpretation based on a predetermined threshold. There is no mention of AI/ML terms or concepts like training/test sets for model development.

Therapeutic

No.
This device is an in vitro diagnostic (IVD) device used for the qualitative detection of Chlamydia trachomatis DNA to aid in diagnosis, not to provide therapy or treatment.

Diagnostic

Yes

The intended use explicitly states "The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease."

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components like microwells, enzymes, and a thermally-controlled fluorescent reader (BD Viper System) used for amplification and detection. While software is involved in data analysis and reporting, the core functionality relies on physical reagents and instrumentation.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is for the "direct, qualitative detection of Chlamydia trachomatis DNA" in various human specimens (swabs and urine). It also states it is intended "to aid in the diagnosis of chlamydial urogenital disease." This clearly indicates the device is used to test specimens taken from the human body to provide information for diagnostic purposes.
• Device Description: The description details the process of analyzing DNA from specimens using amplification and detection technology. This is a typical process for in vitro diagnostic tests.
• BD Viper System: The description of the BD Viper System explicitly states it is "intended for the in vitro detection of targeted organisms from specimens."
• Performance Studies: The document describes clinical performance studies using human specimens (endocervical swabs, PreservCyt specimens) to evaluate the assay's sensitivity and specificity in diagnosing Chlamydia trachomatis. This type of testing is characteristic of IVD validation.
• Predicate Device: The mention of predicate devices (BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay and Gen-Probe APTIMA Assay for Chlamydia trachomatis (ACT)) which are known IVDs further supports that this device falls into the same category.

All these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility of human tissues, organs or blood, or to monitor therapeutic measures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The BD ProbeTecT™ Chlamydia trachomatis (CT) 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 Chlamydia trachomatis 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 also intended for use with gynecological specimens collected in PreservCvt® Solution using an aliquot that is removed prior to processing for additional gynecological testing. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial 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).

Product codes (comma separated list FDA assigned to the subject device)

MKZ

Device Description

The BD ProbeTec CT Q* Amplified DNA Assay is based on the simultaneous amplification and detection of target DNA using amplification primers and a fluorescently-labeled detector probe (8, 9). 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 thermally-controlled fluorescent readers. The presence or absence of C. trachomatis 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 C. trachomatis 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 C. trachomatisspecific 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 C. trachomatis-specific signals to report results as positive, negative, or EC failure.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Female endocervical, male urethral, vaginal, urogenital

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Clinician-collected, clinical setting

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Analytical Performance Characteristics
Limit of Detection (Analytical Sensitivity)
The Limits of Detection (LODs) for the CT Q* Assay with C. trachomatis seroyar H in PreservCyt specimens when extracted on the BD Viper System were determined to be 95% proportion positive at a concentration of 15 EB per mL in clean diluted PreservCyt Solution.

Interfering Substances
Potential interfering substances which may be encountered in PreseryCyt specimens were extracted from diluted PreservCyt matrix in the absence and presence of CT target (90 CT EBs/mL) and tested with the BD ProbeTec CT Q* Amplified DNA Assay on the BD Viper System.
No interference observed with Blood (

Regulation Number and Section

§ 866.3120 Chlamydia serological reagents.

(a)
Identification. Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusChlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).(b)
Classification. Class I (general controls).

Summary

0

BD

Helping all people
live healthy lives

BD ProbeTec™ Chlamydia trachomatis (CT) ( Amplified DNA Assay

| Applicant | BD Diagnostic Systems
7 Loveton Circle
Sparks, MD 21152 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration No. | 1119779 |
| Contact Person | Saba Modjarrad
tel. [phone]
fax. [phone]
[e-mail] |
| Summary Date | March 25, 2009 |
| Proprietary Name | BD ProbeTec TM Chlamydia trachomatis (CT) Q x Amplified DNA Assay |
| Generic Name | DNA probe, nucleic acid amplification, Chlamydia |
| Classification | Class I |
| Classification Name | Chlamydia serological reagents |
| Regulation Number | 866.3120 |
| Product Code | MKZ |
| Predicate Devices | BD ProbeTec TM Chlamydia trachomatis (CT) Q x Amplified DNA Assay (K081824),
Gen-Probe APTIMA Assay for Chlamydia trachomatis (ACT) (K053446) |

Device Description

The BD ProbeTec CT Q* Amplified DNA Assay is based on the simultaneous amplification and detection of target DNA using amplification primers and a fluorescently-labeled detector probe (8, 9). 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 thermally-controlled fluorescent readers. The presence or absence of C. trachomatis DNA is determined by calculating the peak

1

Image /page/1/Picture/1 description: The image shows the BD logo. The logo consists of a stylized sun-like graphic 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."

BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay

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 C. trachomatis 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 C. trachomatisspecific 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 C. trachomatis-specific signals to report results as positive, negative, or EC failure.

Intended Use

The BD ProbeTecT™ Chlamydia trachomatis (CT) 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 Chlamydia trachomatis 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 also intended for use with gynecological specimens collected in PreservCvt® Solution using an aliquot that is removed prior to processing for additional gynecological testing. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease.

Summary and Principles of Operation

When used with the BD Viper System, the BD ProbeTec CT Q* Amplified DNA 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, C. trachomatis 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 CT Q* Assay with C. trachomatis seroyar H in PreservCyt specimens when extracted on the BD Viper System were determined to be ≤ 30 CT EB per mL. A correlation of EB to IFU suggests that the CT Q* assay LODs with serovar H in PreservCyt specimens correspond to ≤ 1 IFU per mL. The CT Q* Assay on the BD Viper System in extracted mode was able to detect 16 CT serovars with > 95% proportion positive at a concentration of 15 EB per mL in clean diluted PreservCyt Solution.

2

Image /page/2/Picture/1 description: The image shows the logo for BD, a medical technology company. The logo consists of a stylized sun-like graphic with a smiling face incorporated into the design, followed by the letters "BD" in bold font. Below the letters, the company's slogan reads, "Helping all people live healthy lives" in a smaller, italicized font.

BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay

Interfering Substances

Potential interfering substances which may be encountered in PreseryCyt specimens were extracted from diluted PreservCyt matrix in the absence and presence of CT target (90 CT EBs/mL) and tested with the BD ProbeTec CT Q* Amplified DNA Assay on the BD Viper System. Results are summarized in Table 2.

Table 2 Interfering Substances

Interpretation	PreservCyt
No Interference Observed	Blood (≤ 1%)
Seminal Fluid
Mucus
Over The Counter vaginal products and contraceptives
Hemorrhoidal cream
Prescription vaginal treatments
Leukocytes (1x106 cells/mL)
1x106 cells/mL Neisseria gonorrhoeae
May cause extraction control
(EC) failures	Glacial Acetic Acid + Blood (≤5%/1% V/V)
May cause False Negative
results	Glacial Acetic Acid + Blood (≤5%/1% V/V)

Clinical Performance Characteristics

Endocervical swab specimens and PreservCyt specimens were collected from 2079 compliant female subjects attending family planning, OB/GYN, and sexually transmitted disease clinics at eleven geographically diverse clinical sites in North America. Subjects were classified as symptomatic if they reported symptoms such as dysuria, coital pain/difficulty/bleeding, abnormal vaginal discharge, or pelvic/uterine/adnexal pain. Subjects were classified as asymptomatic if they did not report symptoms. Five subjects were excluded due to an undetermined patient infected status. Three subjects did not have a PreservCyt specimen result. There were 2071 subjects evaluated.

Three randomized endocervical swab specimens and a PreservCyt specimen were collected from each female subject. The three reference endocervical swabs were tested with the BD ProbeTec ET CT/GC/AC assay, the BD ProbeTec CT Q* assay, and another commercially available NAAT (Nucleic Acid Amplification Test). Sensitivity and specificity for PreservCyt specimens were calculated by comparing results to a patient infected status (PIS) algorithm. The designation of positive or negative PIS was based on the endocervical swab specimen results

3

Image /page/3/Picture/1 description: The image shows the BD logo. On the left is an image of a person with their arms raised, with rays of light emanating from behind them. To the right of the image are the letters "BD" in bold font. Below the letters is the text "Helping all people live healthy lives".

BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay

from the three reference methods. At least two positive reference results were required to establish a subject as PIS-positive. At least two negative reference results were required to establish a subject as PIS-negative. Sensitivity and specificity by symptomatic status are presented in Table 4.

The distribution of cervical sampling devices used in the clinical study according to clinical collection site is summarized in Table 3.

Table 3 Summary of Cervical Sampling Devices Used in the PreservCyt Specimen Clinical Study

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Table 4 CT Q+ Assay Performance for PreservCyt Specimens Compared to Patient Infected Status (by symptomatic status)

Performance Compared to Patient Infected Status
Symptomatic	n	Sensitivity	95% C.I.	Specificity	95% C.I.	PPV%	NPV%	Error Initial/Final
A	1347	91.9%
(68/74)	(83.2% -
97.0%)	99.8%
(1271/1273)	(99.4% -
100.0%)	96.4%	99.5%	1/0
S	724	96.7%
(59/61)	(88.7% -
99.6%)	99.8% (662/663)	(99.2% -
100.0%)	97.8%	99.7%	0/0
Total	2071	94.1%
(127/135)	(88.7% -
97.4%)	99.8%
(1933/1936)	(99.5% -
100.0%)	97.0%	99.6%	1/0

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Image /page/4/Picture/1 description: The image shows the logo for BD, a medical technology company. The logo consists of two parts: a stylized sun-like symbol with a human figure in the center, and the letters "BD" in bold font. Below the letters, there is a tagline that reads "Helping all people live healthy lives."

BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay

A total of 2071 CT Q* Assay results from PreservCyt specimens was evaluated from cleven geographically diverse clinical sites. A frequency distribution of the initial MaxRFU values for the CT Q* assay is shown in Figure A.

Image /page/4/Figure/4 description: The image shows the title of a figure. The title is "Figure A Frequency Distribution of MaxRFU for the CT Q* Assay (PreservCyt Specimens)". The title indicates that the figure will show the frequency distribution of MaxRFU for the CT Q* Assay.

Image /page/4/Figure/5 description: The image is a bar graph showing frequency on the y-axis and MaxRFU on the x-axis. The first bar, representing 0-49 MaxRFU, has a frequency of 1930. The bar representing >=800 MaxRFU has a frequency of 128, while the other bars have frequencies of 0 or 1.

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Image /page/5/Picture/1 description: The image shows the BD logo. The logo consists of a stylized sun-like graphic on the left and the letters "BD" in bold font on the right. Below the letters, there is a tagline that reads "Helping all people live healthy lives" in a smaller font.

BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay

Reproducibility

A reproducibility study of the BD Viper System using the BD ProbeTec CT Q* Assay was conducted for Liquid Based Cytology (LBC) specimens at three clinical sites on one BD Viper System per site. A panel of simulated specimens comprising CT and GC organisms seeded into LBC Specimen Dilution Tubes containing LBC medium was tested with the BD ProbeTec CT Q Assay. Uninoculated LBC Specimen Dilution Tubes containing LBC medium were used for the CT 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 S.

Two additional target levels were included in the panels 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 CT Q* Assay. These additional specimens comprised CT and GC organisms seeded into LBC Specimen Dilution Tubes containing LBC medium at dilutions of 1:10 and 1:100 of the respective analytical LODs of each analyte. These levels were selected to fall within the dynamic range of the analytical LOD curves for the BD ProbeTec CT Q and GC Q assays. Nine replicates of each panel member were tested every day for five days across the three BD Viper Systems. The data are summarized in Table 6.

Table 5 Summary of Reproducibility Data for LBC Specimens on the BD Viper System for the CT Q* Assay

| CT
EBs/mL | GC
Cells/mL | %
Correct | 95% CI | Mean
MaxRFU | Within Run | | | Between Runs
Within Site | | Between
Site | |
|--------------|----------------|---------------------|---------------------|----------------|------------|--------|--|-----------------------------|-------|-----------------|-------|
| 0 | 0 | 100.0%
(135/135) | (97.3% -
100.0%) | 1.30 | 4.66 | 357.64 | | 0.85 | 65.29 | 0.20 | 15.12 |
| 30 | 0 | 100.0%
(135/135) | (97.3% -
100.0%) | 2021.95 | 225.94 | 11.17 | | 16.58 | 0.82 | 21.52 | 1.06 |
| 0 | 100 | 100.0%
(135/135) | (97.3% -
100.0%) | 1.35 | 3.63 | 268.97 | | 0.00 | 0.00 | 0.87 | 64.48 |
| 30 | 250 | 100.0%
(135/135) | (97.3% -
100.0%) | 2028.41 | 155.45 | 7.66 | | 9.93 | 0.49 | 0.00 | 0.00 |
| 75 | 100 | 100.0%
(135/135) | (97.3% -
100.0%) | 1964.40 | 170.91 | 8.70 | | 44.37 | 2.26 | 8.70 | 0.44 |

Page 6 of 7

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Image /page/6/Picture/1 description: The image shows the logo for BD, a medical technology company. The logo consists of a stylized sunburst graphic to the left, followed by the letters "BD" in bold, sans-serif font. Below the letters, the company's tagline reads "Helping all people live healthy lives" in a smaller, more delicate font.

BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay

Table 6 Characterization of System Reproducibility at Target Levels below the Analytical Limit of Detection for the CT Q* Assay for LBC Specimens

| Dilution
of
Analytical
LOD | % Positive | 95% CI
(Positive) | MaxRFU
Mean
(Positive) | % Negative | 95% CI
(Negative) | MaxRFU
Mean
(Negative) |
|-------------------------------------|---------------|----------------------|------------------------------|----------------|----------------------|------------------------------|
| 1:10 | 50.4 (68/135) | (41.6 - 59.1) | 1935.9 | 49.6 (67/135) | (40.9 - 58.4) | 11.5 |
| 1:100 | 7.4 (10/135) | (3.6 - 13.2) | 1835.7 | 92.6 (125/135) | (86.8 - 96.4) | 9.4 |

Conclusions

The analytical and clinical study results for the BD ProbeTec Chlamydia trachomatis (CT) Q* Amplified DNA Assay with PreservCyt specimens support the determination of substantial equivalence in accordance with the intended use as stated in the product labeling.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's commitment to health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Saba Modiarrad Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152

JUN - 2 2009

Re: K090824

Trade/Device Name: BD Probetec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay

Regulation Number: 21 CFR 866.3120 Regulation Name: Chlamydia serological reagents Regulatory Class: Class I Product Code: MKZ Dated: March 25, 2009 Received: March 26, 2009

Dear Ms. Modjarrad:

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 indicrions for use stated in the enclosure) to legally marketed predicate devices market the interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmonts, or to devices that have been reclassified in accordance with the provisions of the Federallients, ou o 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, l'usting 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 Dov. In a

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 prectice 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 Biometrio'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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sally attaym

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

9

Indications for Use

1090824 510(k) Number (if known):

Device Name: BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay

Indications For Use:

The BD ProbeTec™ Chlamydia trachomatis (CT) 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 Chlamydia trachomatis 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 also intended for use with gynecological specimens collected in PreservCyt® Solution using an aliquot that is removed prior to processing for additional gynecological testing. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial 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).

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)

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Office of In Vitro Diagnostic Device
Evaluation and Safety510(k) K090824

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BD Diagnostic Systems Becton, Dickinson and Company

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