The BD ProbeTec Chlamydia trachomatis (CT) 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 Chlamydia trachomatis 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 individuals to aid in the diagnosis of chlamydial urogenital disease.

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

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" with numerical targets for sensitivity and specificity. Instead, it presents the results of clinical performance studies, implying that these results met the internal or regulatory expectations for substantial equivalence. For a medical device, the ultimate acceptance criterion for performance is typically demonstrating substantial equivalence to a legally marketed predicate device through clinical performance.

However, based on the clinical performance table, we can infer the achieved performance:

Specimen Type (Symptomatic Status)	Performance Metric	Reported Device Performance
Female Endocervical Swab (FS)	Sensitivity	91.3% (84.6%-95.8% CI)
(Total)	Specificity	98.3% (97.2%-99.0% CI)
Female Vaginal Swab (FV)	Sensitivity	96.5% (91.3%-99.0% CI)
(Total)	Specificity	99.2% (98.4%-99.7% CI)
Female Neat Urine (FN)	Sensitivity	93.0% (86.8%-96.9% CI)
(Total)	Specificity	99.4% (98.7%-99.8% CI)
Female Urine in Q UPT (FUPT)*	Sensitivity	93.0% (86.8%-96.9% CI)
(Total)	Specificity	99.2% (98.4%-99.7% CI)
Male Urethral Swab (MS)	Sensitivity	92.1% (85.0%-96.5% CI)
(Total)	Specificity	98.4% (96.5%-99.4% CI)
Male Neat Urine (MN)	Sensitivity	98.0% (93.0%-99.8% CI)
(Total)	Specificity	99.2% (97.7%-99.8% CI)
Male Urine in Q UPT (MUPT)*	Sensitivity	98.0% (93.0%-99.8% CI)
(Total)	Specificity	98.1% (96.2%-99.2% CI)
Overall Total	Sensitivity	94.5% (92.6%-96.0% CI)
	Specificity	98.9% (98.6%-99.2% CI)

Analytical Sensitivity (Limit of Detection):

≤ 15 CT elementary bodies (EB) per mL for neat and UPT treated urine (serovar H)
≤ 30 CT EB per mL for expressed vaginal and endocervical swab specimens (serovar H)
Able to detect 16 CT serovars with ≥ 95% proportion positive at 15 EB per mL in Q* Swab Diluent.

Analytical Specificity:

Did not cross-react with any of the 141 organisms tested (Table 1 lists a comprehensive range of bacteria, viruses, and fungi).

Interfering Substances:

No interference observed for a wide range of substances in swab and urine (Table 2).
Potential for extraction control (EC) failures with blood (> 60%) in swabs.

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

Sample Size (Clinical Performance Test Set):
- Female Subjects: 994 compliant subjects (initially 1059 collected).
- Male Subjects: 472 compliant subjects (initially 479 collected).
- Total BD ProbeTec CT Q Assay results used for calculations:* 5388 individual assay results across various specimen types.
Data Provenance:
- Country of Origin: North America (United States is implied by the FDA submission, but "North America" is explicitly stated).
- Retrospective or Prospective: Prospective. Subjects were recruited and specimens collected from OB/GYN, sexually transmitted disease (STD), and family planning clinics.

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

The ground truth was established by a "patient infected status (PIS) algorithm" based on the results of two commercially available NAATs (Nucleic Acid Amplification Tests):

BD ProbeTec ET CT/AC assay (predicate device, K984631)
Another unspecified commercially available NAAT.
Number of Experts: Not applicable in the traditional sense of human expert review. The ground truth was determined algorithmically by comparing results from the two reference NAATs.
Qualifications of Experts: Not applicable, as the ground truth was based on the performance of existing, validated commercial assays rather than human expert opinion.

4. Adjudication Method for the Test Set

Adjudication Method: Algorithmic consensus.
- "Subjects were considered infected with CT 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 CT/AC assay AND the other reference NAAT (one specimen testing positive in each NAAT)." This effectively describes a 2/2 consensus or a complex majority rule across different specimen types and reference assays.
- "Subjects were considered non-infected if less than two reference NAAT results were positive."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) assay where the result is generated by the instrument (BD Viper System) based on DNA amplification and detection, not by human readers interpreting images or data. The study compares the device's performance to established reference laboratory methods, not to human interpretation with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the device's performance, as reported in the clinical performance section, is a standalone (algorithm only) performance. The BD ProbeTec CT Q* Amplified DNA Assay is an automated test performed on the BD Viper™ System. The system "monitors" fluorescence and applies an "automated algorithm" to report results (positive, negative, or EC failure). There is no human interpretation involved in generating the primary result for comparison to the ground truth.

7. The Type of Ground Truth Used

The ground truth used was a composite reference standard or patient infected status (PIS) algorithm based on the results of two other commercially available and legally marketed nucleic acid amplification tests (NAATs). It is not pathology, a definitive gold standard, or outcome data in the traditional sense, but a robust consensus based on highly sensitive and specific molecular methods.

8. The Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its sample size for the clinical performance evaluation. The clinical study described appears to be a validation study for the assay. For IVDs, "training" might refer to internal development and optimization phases, which are typically not detailed in 510(k) summaries. The data presented in the clinical performance section represents the results from the final, evaluated test set.

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

As there is no explicitly defined "training set" presented in the document, information on how its ground truth was established is not available. The ground truth for the validation set was established using the PIS algorithm based on the two reference NAATs, as described in point 4.

Summary

{0}------------------------------------------------

K0Y1324

Image /page/0/Picture/1 description: The image shows the BD logo, which consists of a stylized sun-like symbol with a human figure at the center, followed by the letters "BD" in bold. Below the letters, there is a tagline that reads "Helping all people live healthy lives". The logo is in black and white.

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

510(k) Summary

DEC 11 2008

Applicant	BD Diagnostic Systems7 Loveton CircleSparks, MD 21152
Establishment Registration No.	1119779
Contact Person	Kathryn Babka Carr, RACtel. 410-316-4260fax. 410-316-4041Kathy_Carr@bd.com
Summary Date	December 1, 2008
Proprietary Name	BD ProbeTec™ Chlamydia trachomatis (CT) Q* 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 ET CT/GC Amplified DNA Assay (K984631),APTIMA Combo 2 Assay (K003395)

Device Description

{1}------------------------------------------------

Image /page/1/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 on the left and the letters "BD" in bold, sans-serif font on the right. Below the letters, there is a tagline that reads "Helping all people live healthy lives" in a smaller font size.

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

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 ProbeTec" 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 swabs, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens. The assay is indicated for use with asymptomatic 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 (CT Q* 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 serovar H in urine and swab specimens when extracted on the BD Viper System were determined to be ≤15 CT elementary bodies (EB) per mL for neat and UPT treated urine and ≤30 CT EB per mL for expressed vaginal and endocervical swab specimens. A correlation of EB to IFU suggests that the CT Q* assay LODs with serovar H in urine and swab specimens correspond to ≤ 1 IFU per mL (15). 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 Q* Swab Diluent.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the BD logo, which consists of a stylized sun-like symbol to the left and the letters "BD" in bold to the right. Below the letters, there is a tagline that reads "Helping all people live healthy lives." The logo is in black and white.

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

Analytical Specificity

The 141 organisms listed in Table 1 were tested with the BD ProbeTec CT Q Amplified DNA Assay on the BD Viper System. All potential cross-reactive species were tested at ≥ 1x10° cells/mL except where noted. The CT Q Assay did not cross-react with any of the organisms tested.

Acinetobacter calcoaceticus	Epstein Barr Virus ***	Peptostreptococcus productus	Neisseria elongata subsp.nitroreduscens (2)
Acinetobacter Iwoffi	Escherichia coli	Plesiomonas shigelloides	Neisseria elongata
Actinomyces israelii	Flavobacterium meningosepticum	Propionibacterium acnes	Neisseria flava (4)
Adenovirus***	Gardnerella vaginalis	Providencia stuartii	Neisseria flavescens (4)
Aeromonas hydrophilia	Gemella haemolysans	Pseudomonas aeruginosa	Neisseria gonorrhoeae
Alcaligenes faecalis*	Haemophilus influenzae	Salmonella minnesota	Neisseria lactamica (7)
Bacillus subtilis*	Herpes Simplex Virus **	Salmonella typhimurium	Neisseria meningitidis (12)
Bacteroides fragilis	Human papillomavirus (16 and 18)***	Staphylococcus aureus	Neisseria mucosa (5)
Candida albicans*	Kingella kingae	Staphylococcus epidermidis	Neisseria perflava (8)
Candida glabrata*	Klebsiella pneumoniae	Streptococcus agalactiae	Neisseria polysaccharea (2)
Candida tropicalis*	Lactobacillus acidophilus*	Streptococcus mitis	Neisseria sicca (5)
Chlamydia pneumoniae****	Lactobacillus brevis	Streptococcus mutans	Neisseria subflava (15)
Chlamydia psittaci*	Lactobacillus jensenii*	Streptococcus pneumoniae*	Neisseria weaverii (3)
Citrobacter freundii	Listeria monocytogenes	Streptococcus pyogenes
Clostridium perfringens	Mobiluncus mulieris	Streptomyces griseus**
Corynebacterium renale	Moraxella lacunata*	Trichomonas vaginalis**
Cryptococcus neoformans*	Moraxella osloensis	Veillonella parvula
Cytomegalovirus**	Morganella morganii	Vibrio parahaemolyticus
Edwardsiella tarda	Mycobacterium gordonae	Yersinia enterocolitica
Enterobacter cloacae	Mycobacterium smegmatis	Branhamella catarrhalis (5)
Enterococcus faecalis	Peptostreptococcus anaerobius	Neisseria cinerea (2)
Enterococcus faecium	Peptostreptococcus asaccharolyticus	Neisseria elongata ssglycolytica

(n) number of strains tested in the BD ProbeTec CT Q* Assay

Tested at > 1x10 cells/nL; ** Tested at > 1x10 cells or viral particles per mL; *** Tested at ≥ 1x10 genomic equivalents per mL;

*** tested at ≥ 1x108 TCID30/mL

{3}------------------------------------------------

Image /page/3/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

Interfering Substances

Potential interfering substances which may be encountered in swab and/or urine specimens were extracted from urine and vaginal swab matrix in the absence and presence of CT target (30 CT EBs/mL for urine and 90 CT EBs/mL for swabs) and tested with the BD ProbeTec CT Q* Amplified DNA Assay on the BD Viper System. Results are summarized in Table 2.

Interpretation	Swab	Urine
No Interference Observed	Blood (≤ 60%)Seminal FluidMucusOver The Counter vaginalproducts and contraceptivesHemorrhoidal creamPrescription vaginal treatmentsLeukocytes (1x106 cells/mL)1x106 cells/mL Neisseriagonorrhoeae	Blood (1%)Seminal fluidMucusAntibioticsAnalgesicsOver The Counter deodorant sprays andpowdersHormonesLeukocytesAlbumin <1 mg/mLGlucoseAcidic urine (pH 4.0)Alkaline urine (pH 9.0)BilirubinOrganisms associated with Urinary TractInfections
May cause extractioncontrol (EC) failures	Blood (> 60%)	Not observed

Table 2: Interfering Substances

Clinical Performance Characteristics

Clinician-collected endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female Q UPT and neat urine specimens were collected from 1059 female subjects and 479 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 7 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 472 compliant male subjects.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for BD, a global medical technology company. The logo consists of two parts: a symbol on the left and the letters "BD" on the right. The symbol features a stylized human figure with arms raised towards a sun-like burst of rays. Below the logo is the tagline "Helping all people live healthy lives".

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

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 472 eligible male subjects. Up to three randomized urethral swab specimens were collected followed by a urine specimen that was split into Q UPT, neat urine and the two reference urine specimen collection devices. BD ProbeTec CT 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 CT/AC assay and another commercially available NAAT (Nucleic Acid Amplification Test). Specimen testing was conducted either at the site of specimen collection or at a designated BD Viper testing site.

All performance calculations were based on the total number of BD ProbeTec CT 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 CT or not was based on endocervical swab and urine specimen results from the commercially available BD ProbeTec ET CT/AC assay and the other commercially available NAAT. Subjects were considered infected with CT 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 CT/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 5388 BD ProbeTec CT Q* Assay results was used to calculate sensitivity and specificity. Sensitivity and specificity by specimen type and symptomatic status are presented in Table 3.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for BD, a medical technology company. The logo consists of a stylized sunburst with a human figure in the center, followed by the letters "BD" in bold font. Below the letters, the tagline "Helping all people live healthy lives" is printed in a smaller font.

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

Table 3: CT Q+ Assay Performance Compared to Patient Infected Status (by specimen type and symptomatic status)

SpecimenType	Symptomatic	N	Sensitivity	95% C.I.	Specificity	95% C.I.	PPV%	NPV%	ErrorInitial/Final
FS	N	450	93.0% (53/57)	(83.0%-98.1%)	98.0% (385/393)	(96.0%-99.1%)	86.9	99.0	2/0
	Y	543	89.7% (52/58)	(78.8% -96.1%)	98.6% (478/485)	(97.0%-99.4%)	88.1	98.8	1/1
	Total	993	91.3% (105/115)	(84.6%-95.8%)	98.3% (863/878)	(97.2%-99.0%)	87.5	98.9	3/1
FV	N	449	98.2% (56/57)	(90.6%-100.0%)	99.5% (390/392)	(98.2%-99.9%)	96.6	99.7	0/0
	Y	544	94.8% (55/58)	(85.6%-98.9%)	99.0% (481/486)	(97.6%-99.7%)	91.7	99.4	0/0
	Total	993	96.5% (111/115)	(91.3%-99.0%)	99.2% (871/878)	(98.4%-99.7%)	94.1	99.5	0/0
FN	N	450	93.0% (53/57)	(83.0% -98.1%)	100.0% (393/393)	(99.1%-100.0%)	100.0	99.0	0/0
	Y	543	93.1% (54/58)	(83.3%-98.1%)	99.0% (480/485)	(97.6%-99.7%)	91.5	99.2	0/0
	Total	993	93.0% (107/115)	(86.8%-96.9%)	99.4% (873/878)	(98.7%-99.8%)	95.5	99.1	0/0
FUPT	N	450	94.7% (54/57)	(85.4%-98.9%)	99.5% (391/393)	(98.2%-99.9%)	96.4	99.2	0/0
	Y	543	91.4% (53/58)	(81.0% - 97.1%)	99.0% (480/485)	(97.6%-99.7%)	91.4	99.0	0/0
	Total	993	93.0% (107/115)	(86.8%-96.9%)	99.2% (871/878)	(98.4%-99.7%)	93.9	99.1	0/0
MS	N	215	88.6% (31/35)	(73.3% -96.8%)	98.9% (178/180)	(96.0%-99.9%)	93.9	97.8	1/0
	Y	257	93.9% (62/66)	(85.2%- 98.3%)	97.9% (187/191)	(94.7%-99.4%)	93.9	97.9	1/0
	Total	472	92.1% (93/101)	(85.0%-96.5%)	98.4% (365/371)	(96.5%-99.4%)	93.9	97.9	2/0
MN	N	215	100.0% (35/35)	(90.0% 100.0%)	98.9% (178/180)	(96.0%-99.9%)	94.6	100.0	0/0
	Y	257	97.0% (64/66)	(89.5%-99.6%)	99.5% (190/191)	(97.1% 100.0%)	98.5	99.0	0/0
	Total	472	98.0% (99/101)	(93.0%-99.8%)	99.2% (368/371)	(97.7%-99.8%)	97.1	99.5	0/0
MUPT	N	215	100.0% (35/35)	(90.0% 100.0%)	98.9% (178/180)	(96.0%-99.9%)	94.6	100.0	0/0
	Y	257	97.0% (64/66)	(89.5%-99.6%)	97.4% (186/191)	(94.0%-99.1%)	92.8	98.9	0/0
	Total	472	98.0% (99/101)	(93.0%-99.8%)	98.1% (364/371)	(96.2%-99.2%)	93.4	99.5	0/0
Total		5388	94.5% (721/763)	(92.6% -96.0%)	98.9% (4575/4625)	(98.6%-99.2%)	93.5	99.1	5/1

A
Filu FS

Asymptomatic Confidence Interval Female Neal Urine
Female endocervical swab Female urine in Q* UPT Female vaginal swab
Male Neat Unne Male urethral swab

FUPT

MNU

ભટ

UPT
ab

Male urine in Q* UPT
number

Symptomatic

MUPT

n
S

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the BD logo, which consists of a stylized sun-like symbol with a human figure at the bottom left and the letters 'BD' in bold font to the right. Below the logo, there is the text 'Helping all people live healthy lives' in a smaller font size. The logo is simple and clean, with a focus on the company's mission of promoting health and well-being.

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

A total of 5388 CT Q* Assay results was evaluated at seven geographically diverse clinical sites. A frequency distribution of the initial MaxRFU values for the CT Q Assay with an assay cutoff of 125 MaxRFU is shown in Figure A.

Image /page/6/Figure/4 description: This bar graph shows frequency on the y-axis and different ranges of numbers on the x-axis. The first bar is the tallest, with a value of 4590 in the 0-49 range. The last bar is the second tallest, with a value of 755 in the >=800 range. The other ranges have values between 0 and 26.

Image /page/6/Figure/5 description: The image is titled "Figure A: Frequency Distribution of MaxRFU for the CT Q* Assay". The title is written in a bold, sans-serif font. The text is centered horizontally.

MaxRFU

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the logo for BD, a medical technology company. The logo consists of a stylized sun-like symbol on the left and the letters "BD" in bold, sans-serif font on the right. Below the letters, there is a tagline that reads "Helping all people live healthy lives" in a smaller font size.

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

Reproducibility

Reproductibility of the BD Viper System using the BD ProbeTec CT Q* Assay was evaluated at three clinical sites on one BD Viper System per site. A panel of simulated specimens was tested that comprised CT and GC organisms seeded into swab diluent for the BD ProbeTec CT Q Assay. Simulated endocervical and urethral specimens contained a clean endocervical swab whereas the simulated urine end vaginal swab specimens did not. Uninoculated swab diluent for the BD ProbeTec CT Q* Assay was 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 4.

'Table 4: Summary of Reproducibility Data on the BD Viper Svstem for the CT Of Assa .

Specimen Type	CTEB/mL	GCCells/mL	% Correct	95% CI	MaxRFUMean	Within Run		Between RunsWithin Site		Between Site
						SD	%CV	SD	%CV	SD	%CV
Endocervical/Urethral	0	0	98.5%(133/135)	(94.8-99.8%)	29.9	233.0	778.5	0.0	0.0	33.9	113.4
	30	0	100.0%(135/135)	(97.3-100.0%)	2011.2	114.1	5.7	0.0	0.0	14.8	0.7
	0	100	100.0%(135/135)	(97.3-100.0%)	1.4	6.0	442.7	1.0	76.9	0.0	0.0
	30	250	100.0%(135/135)	(97.3-100.0%)	1991.9	118.0	5.9	17.6	0.9	10.4	0.5
	75	100	100.0%(135/135)	(97.3-100.0%)	1954.8	169.4	8.7	0.0	0.0	0.0	0.0
Urine/Vaginal	0	0	100.0%(135/135)	(97.3-100.0%)	0.9	5.0	542.4	0.0	0.0	0.0	0.0
	30	0	100.0%(135/135)	(97.3-100.0%)	1999.8	131.8	6.6	34.2	1.7	0.0	0.0
	0	100	100.0%(135/135)	(97.3-100.0%)	0.8	3.4	442.4	0.0	0.0	0.0	0.0
	30	250	100.0%(135/135)	(97.3-100.0%)	1995.2	125.8	6.3	33.1	1.7	52.9	2.7
	75	100	100.0%(135/135)	(97.3-100.0%)	2014.4	109.5	5.4	0.0	0.0	0.0	0.0

A second study was conducted internally 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. A panel of simulated specimens was tested that comprised CT and GC organisms seeded into Q* swab diluent at two different levels each of which was below the respective analytical LOD for the organisms (1:10, 1:100). These levels were selected to fall within the dynamic range of the analytical LOD curve of the assay. Fifteen replicates of each panel member were tested every day for five days across three BD Viper Systems. The data are summarized in Table 5.

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the logo for BD, a medical technology company. The logo consists of two parts: a stylized 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

Table 5: Characterization of System Reproducibility at Target Levels below the Analytical Limit of Detection for the CT Q* Assay.

Endocervical/Urethral	1:10	70.2(158/225)	(63.8, 76.1)	1794.2	29.8(67/225)	(23.9, 36.2)	2.6
Endocervical/Urethral	1:100	10.2(23/225)	(6.6,14.9)	1643.8	89.8(202/225)	(85.1, 93.4)	1.6
Urine/Vaginal	1:10	64.4(145/225)	(57.8, 70.7)	1733.9	35.6(80/225)	(29.3, 42.2)	4.6
Urine/Vaginal	1:100	10.7(24/225)	(7.0, 15.5)	1666.6	89.3(201/225)	(84.5, 93.0)	2.4

Conclusions

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

{9}------------------------------------------------

Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Public Health Service

DEC I 1 2008

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Becton, Dickinson and Company Kathryn Babka Carr, Sr. Regulatory Affairs Specialist / Regulatory Affairs 7 Loveton Circle Sparks, MD 21152

Re: K081824

Trade/Device Name: BD ProbeTecCT Q* Amplified DNA Assay Regulation Number: 21 CFR 866.3120 Regulation Name: Chlamydia Serological Reagents Regulatory Class: Class I Product Code: MKZ Dated: December 5, 2008 Received: December 9, 2008

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). 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

{10}------------------------------------------------

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 yours,

Sally attaym

Sally A. Hoivat, 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

{11}------------------------------------------------

Indications for Use

510(k) Number: K081824

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

Indications For Use:

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)

Une Schaf

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 6 8 18 24

BD Diagnostic Systems Becton, Dickinson and Company

Page ix

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).