Predicate Devices

LSL, MKZ

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a DNA amplification and detection system based on established molecular biology techniques (SDA and ET). It mentions using "an algorithm" to report results based on comparing a metric (MOTA score) to pre-determined cutoff values, which is a standard rule-based approach, not indicative of AI/ML. There is no mention of AI, ML, or related concepts like neural networks, deep learning, or training/inference processes typically associated with AI/ML.

Therapeutic

No
Explanation: The device is described as a diagnostic tool for detecting the presence of specific bacterial DNA, not for treating or preventing disease.

Diagnostic

Yes

The device is intended for the "direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA... as evidence of infection," which directly indicates its use in diagnosing these infections.

SaMD (Software as a Medical Device)

No

The device description clearly outlines the use of physical reagents, microwell strips, enzymes, and a thermally controlled fluorescent reader, indicating it is a hardware-based diagnostic system with associated software for data analysis and reporting.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use explicitly states the device is 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." This involves testing biological specimens in vitro (outside the body) to provide diagnostic information about a patient's health status (presence of infection).
Device Description: The description details a laboratory-based assay that utilizes chemical reactions (Strand Displacement Amplification and fluorescent energy transfer) to analyze DNA from clinical specimens. This is a hallmark of IVD devices.
Performance Studies: The document describes clinical studies where the device's performance (sensitivity and specificity) was evaluated against reference methods (culture and patient infected status) using clinical specimens. This is a standard process for validating IVD devices.
Predicate Devices: The mention of predicate devices (other IVD assays like cell culture and commercially available amplification methods) further confirms that this device falls within the category of IVDs used for diagnosing these infections.

The information provided clearly indicates that the BDProbeTec™ ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Amplified DNA Assays are designed and used for diagnostic testing of biological samples in a laboratory setting, which is the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

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

LSL, MKZ

Device Description

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

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

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Endocervical, Male Urethral

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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 STUDIES:
Precision of the BDProbeTec™ ET CT and GC Amplified DNA Assay was demonstrated by testing a five member panel consisting of four dilutions coinoculated with CT and GC in sample diluent and a negative (uninoculated sample diluent). The five member panel is made up of samples containing 0-100 C. trachomatis EBs/rxn and 0-100 N. gonorrhoeae cells/rxn. This precision panel was run at two clinical sites and internally. Six replicates of each panel were run twice a day for three days. No significant run-to-run or site-to-site variability was observed.

Reproducibility was determined by evaluating one panel consisting of seeded swab specimens, and another panel consisting of seeded buffer to simulate urine specimens. The 30 member swab panels contained 12 replicates of a level seeded with both 500 EBs/rxn (CT) and 500 cells/rxn (GC), 12 replicates of a level seeded with both 50 EBs/rxn (CT) and 30 cells/rxn (GC) and six unseeded samples. The 30 member urine panels contained 12 replicates of a level seeded with both 600 EBs/rxn (CT) and 500 cells/rxn (GC), 12 replicates of a level seed with both 115 EBs/rxn (CT) and 100 cells/rxn (GC) and six unseeded samples. Results were combined across 23 operators and across all sample levels (negative, low level, high level) to estimate reproducibility. Eighteen of 23 (78%) operators were at least 95% reproducible with CT swab specimens: 14/23 (61%) of the operators were at least 95% reproducible for CT buffer specimens. For GC specimens, 22/23 (96%) of the operators were at least 95 % reproducible with GC swab specimens and 20/23 (87%) achieved 95% reproducibility with GC buffer specimens.

The analytical sensitivity (limit of detection) of the BDProbeTec™ ET CT and GC Amplified DNA Assay was determined by diluting 15 C. trachomatis serovars and 39 N. gonorrhoeae strains in CT/GC Diluent. Quantitated CT cultures were diluted to 0,5,15,35,70 and 200 EBs per reaction for each serovar. Quantitated GC cultures were diluted to 0,5,10,15,and 25 cells per reaction for each strain. Samples were processed and assayed in triplicate. The analytical sensitivity of the CT serovars ranged from 5-200 EBs per reaction with a median of 35 EBs per reaction. The LOD of the 39 N. gonorrhoeae strains ranged from 5-25 cells per reaction with a median of 5 cells per reaction. These strains included 14 ATCC strains (including six different N. gonorrhoeae auxotypes) and 25 clinical isolates obtained from geographically diverse sites.

A total of 156 bacteria, viruses, and yeast were tested with the BDProbeTec™ ET CT and GC Amplified DNA Assay. Bacterial isolates were tested using at least 10 Colony Forming Units (CFU)/ml or equivalent copies of genomic DNA. Viruses were tested using at least 10 Plaque Forming Units (PFU)/ml or equivalent copies of genomic DNA. The organisms tested include those commonly found in the urogenital tract as well as others. For Chlamydia trachomatis, all results were negative as expected. Three N. cinerea strains were tested in the BDProbeTec ET GC assay. Of these, two were repeatedly positive. Sixteen N. subflava strains were tested in triplicate. Two strains were positive in one of three replicates. When the new strains were prepared and tested again, all results were negative. Eight N. lactamica strains were tested in triplicate. One strain was positive in one of the three replicates. When that strain was prepared and tested again, all results were negative.

Potential interfering substances which may be encountered in swab and/or urine specimens were tested with the BDProbeTec™ ET CT and GC Amplified DNA Assays. Potential interfering substances were evaluated in the absence of target or with 200 CT EBs per reaction and 200 GC cells per reaction. False negative results may be caused by leukocytes and blood > 5% in swabs and by leukocytes, blood, bilirubin, and phenazopyridine in urine. When using the AC, these substances may also cause indeterminate results.

CLINICAL STUDIES:
Performance characteristics for the BDProbeTec™ ET CT and GC Amplified DNA Assays were established in a multicenter study at seven geographically diverse clinical sites. The final data analysis included 4108 CT and 4105 GC specimens collected from 2109 patients attending sexually transmitted disease clinics, OB/GYN clinics, family planning clinics, adolescent clinics, and emergency rooms. Paired specimens (swab and urine) were collected from 2020 of the 2109 patients. Four endocervical swabs and one urine specimen were collected from female patients. The swabs were tested by cell culture for CT, culture for GC, the BDProbeTec ET assay, and a commercially available amplification method (AMP1). The endocervical swab collection order was rotated throughout the study to minimize effects of collection order. For males, two urethral swabs and one urine specimen were collected. The first swab was used for GC culture and then the BDProbeTec ET assay. The second swab was used for CT cell culture. Male and female urine specimens were tested on both the BDProbeTec ET system and AMP1. If cell culture was negative, but either amplification assay was positive, a DFA test was performed from the cell culture transport medium. A different commercially available amplification assay (AMP2) was performed from culture transport medium for those male patients who had a positive urine AMP1 test and the corresponding swabs were culture negative.

Performance characteristics for CT and GC were calculated both with and without the amplification control (AC). Data are presented without the AC. Assay interpretation differences resulting from use of the AC are footnoted at the bottom of each table.

BDProbeTec ET C. trachomatis results were compared to culture and patient infected status. Performance estimates for each specimen type and symptomatic status are shown in Table 1. A patient was considered if (1) the culture was positive, or (2) positive results were obtained for both AMP1 (in either the swab or urine) and DFA, or (3) AMP1 was positive in both swab and urine paired specimens. Data on pregnant females are footnoted at the bottom of Table 1. Of the 1.419 female swab specimens tested in the clinical evaluations by the BDProbeTec ET CT assay, 101 (7.1%) were classified as grossly bloody and 242 (17.1%) as moderately bloody. Assay performance with moderately to grossly bloody swabs was not statistically different than assay performance with non-bloody or lightly bloody swabs.

BDProbeTec ET N. gonorrohoeae results were compared to culture and patient infected status. Performance estimates for each specimen type and symptomatic status are shown in Table 2. A patient was considered if (1) the culture was positive or (2) in females, if AMP1 was positive in both swab and urine (paired specimens). Data on pregnant females are footnoted at the bottom of Table 2. Of the 1.411 female swab specimens tested in the clinical evaluations by the BDProbeTec ET GC assay, 102 (7.2%) were classified as grossly bloody and 242 (17.2%) as moderately bloody. Assay performance with moderately to grossly bloody swabs was not statistically different than assay performance with non-bloody or lightly bloody swabs.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

BDProbeTec ET C. trachomatis results:
Total Culture Sensitivity: 92.0% (393/427) (89.1-94.4 CI)
Total Culture Specificity: 94.9% (3493/3681) (94.1-95.6 CI)
Total Patient Infected Status Sensitivity: 90.7% (458/505) (87.8-93.1 CI)
Total Patient Infected Status Specificity: 96.6% (3480/3603) (95.9-97.1 CI)

BDProbeTec ET N. gonorrohoeae results:
Total Culture Sensitivity: 96.1% (521/542) (94.1-97.6 CI)
Total Culture Specificity: 98.2% (3131/3188) (97.7-98.6 CI)
Total Patient Infected Status Sensitivity: 95.8% (531/554) (93.8-97.4 CI)
Total Patient Infected Status Specificity: 98.5% (3129/3176) (98.2-99.0 CI)

Predicate Device(s)

Chlamydia cell culture, Neisseria gonorrhoeae culture, Abbott LCx® Chlamydia trachomatis Assay, Abbott LCx® Neisseria gonorrhoeae Assay

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

C. trachomatis .

Table 1: Device Comparison - Chlamydia trachomatis (CT)

3

Table 2: Device Comparison - Neisseria gonorrhoeae (GC)

4

SUMMARY OF PERFORMANCE DATA:

ANALYTICAL STUDIES:

Precision of the BDProbeTec™ ET CT and GC Amplified DNA Assay was demonstrated by testing a five member panel consisting of four dilutions coinoculated with CT and GC in sample diluent and a negative (uninoculated sample diluent). The five member panel is made up of samples containing 0-100 C. trachomatis EBs/rxn and 0-100 N. gonorrhoeae cells/rxn. This precision panel was run at two clinical sites and internally. Six replicates of each panel were run twice a day for three days. No significant run-to-run or site-to-site variability was observed.

Reproducibility was determined by evaluating one panel consisting of seeded swab specimens, and another panel consisting of seeded buffer to simulate urine specimens. The 30 member swab panels contained 12 replicates of a level seeded with both 500 EBs/rxn (CT) and 500 cells/rxn (GC), 12 replicates of a level seeded with both 50 EBs/rxn (CT) and 30 cells/rxn (GC) and six unseeded samples. The 30 member urine panels contained 12 replicates of a level seeded with both 600 EBs/rxn (CT) and 500 cells/rxn (GC), 12 replicates of a level seed with both 115 EBs/rxn (CT) and 100 cells/rxn (GC) and six unseeded samples. Results were combined across 23 operators and across all sample levels (negative, low level, high level) to estimate reproducibility. Eighteen of 23 (78%) operators were at least 95% reproducible with CT swab specimens: 14/23 (61%) of the operators were at least 95% reproducible for CT buffer specimens. For GC specimens, 22/23 (96%) of the operators were at least 95 % reproducible with GC swab specimens and 20/23 (87%) achieved 95% reproducibility with GC buffer specimens.

The analytical sensitivity (limit of detection) of the BDProbeTec™ ET CT and GC Amplified DNA Assay was determined by diluting 15 C. trachomatis serovars and 39 N. gonorrhoeae strains in CT/GC Diluent. Quantitated CT cultures were diluted to 0,5,15,35,70 and 200 EBs per reaction for each serovar. Quantitated GC cultures were diluted to 0,5,10,15,and 25 cells per reaction for each strain. Samples were processed and assayed in triplicate. The analytical sensitivity of the CT serovars ranged from 5-200 EBs per reaction with a median of 35 EBs per reaction. The LOD of the 39 N. gonorrhoeae strains ranged from 5-25 cells per reaction with a median of 5 cells per reaction. These strains included 14 ATCC strains (including six different N. gonorrhoeae auxotypes) and 25 clinical isolates obtained from geographically diverse sites.

5

A total of 156 bacteria, viruses, and yeast were tested with the BDProbeTec™ ET CT and GC Amplified DNA Assay. Bacterial isolates were tested using at least 10° Colony Forming Units (CFU)/ml or equivalent copies of genomic DNA. Viruses were tested using at least 108 Plaque Forming Units (PFU)/ml or equivalent copies of genomic DNA. The organisms tested include those commonly found in the urogenital tract as well as others. For Chlamydia trachomatis, all results were negative as expected. Three N. cinerea strains were tested in the BDProbeTec ET GC assay. Of these, two were repeatedly positive. Sixteen N. subflava strains were tested in triplicate. Two strains were positive in one of three replicates. When the new strains were prepared and tested again, all results were negative. Eight N. lactamica strains were tested in triplicate. One strain was positive in one of the three replicates. When that strain was prepared and tested again, all results were negative.

Potential interfering substances which may be encountered in swab and/or urine specimens were tested with the BDProbeTec™ ET CT and GC Amplified DNA Assays. Potential interfering substances were evaluated in the absence of target or with 200 CT EBs per reaction and 200 GC cells per reaction. False negative results may be caused by leukocytes and blood > 5% in swabs and by leukocytes, blood, bilirubin, and phenazopyridine in urine. When using the AC, these substances may also cause indeterminate results.

CLINICAL STUDIES:

Performance characteristics for the BDProbeTec™ ET CT and GC Amplified DNA Assays were established in a multicenter study at seven geographically diverse clinical sites. The final data analysis included 4108 CT and 4105 GC specimens collected from 2109 patients attending sexually transmitted disease clinics, OB/GYN clinics, family planning clinics, adolescent clinics, and emergency rooms. Paired specimens (swab and urine) were collected from 2020 of the 2109 patients. Four endocervical swabs and one urine specimen were collected from female patients. The swabs were tested by cell culture for CT, culture for GC, the BDProbeTec ET assay, and a commercially available amplification method (AMP1). The endocervical swab collection order was rotated throughout the study to minimize effects of collection order. For males, two urethral swabs and one urine specimen were collected. The first swab was used for GC culture and then the BDProbeTec ET assay. The second swab was used for CT cell culture. Male and female urine specimens were tested on both the BDProbeTec ET system and AMP1. If cell culture was negative, but either amplification assay was positive, a DFA test was performed from the cell culture transport medium. A different commercially available amplification assay (AMP2) was performed from culture transport medium for those male patients who had a positive urine AMP1 test and the corresponding swabs were culture negative.

6

Performance characteristics for CT and GC were calculated both with and without the amplification control (AC). Data are presented without the AC. Assay interpretation differences resulting from use of the AC are footnoted at the bottom of each table.

BDProbeTec ET C. trachomatis results were compared to culture and patient infected status. Performance estimates for each specimen type and symptomatic status are shown in Table 1. A patient was considered if (1) the culture was positive, or (2) positive results were obtained for both AMP1 (in either the swab or urine) and DFA, or (3) AMP1 was positive in both swab and urine paired specimens. Data on pregnant females are footnoted at the bottom of Table 1. Of the 1.419 female swab specimens tested in the clinical evaluations by the BDProbeTec ET CT assay, 101 (7.1%) were classified as grossly bloody and 242 (17.1%) as moderately bloody. Assay performance with moderately to grossly bloody swabs was not statistically different than assay performance with non-bloody or lightly bloody swabs.

BDProbeTec ET N. gonorrohoeae results were compared to culture and patient infected status. Performance estimates for each specimen type and symptomatic status are shown in Table 2. A patient was considered if (1) the culture was positive or (2) in females, if AMP1 was positive in both swab and urine (paired specimens). Data on pregnant females are footnoted at the bottom of Table 2. Of the 1.411 female swab specimens tested in the clinical evaluations by the BDProbeTec ET GC assay, 102 (7.2%) were classified as grossly bloody and 242 (17.2%) as moderately bloody. Assay performance with moderately to grossly bloody swabs was not statistically different than assay performance with non-bloody or lightly bloody swabs.

7

Overall performance of the BDProbeTec™ ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays on the BDProbeTec™ ET System, is substantially equivalent1 to CT cell culture and GC culture methods that were in use prior to May 28, 1976 and to the Abbott LCx ® Chlamydia trachomatis Assay and the Abbott LCx® Neisseria gonorrhoeae Assay.

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

8

| Specimen
Type | S/A | Performance Compared to Culture | | Performance Compared to Patient
Infected Status | | #Indeterminate
Initial/Final
(With AC) | DFA or AMP1 Positive in
either specimen type/
BDPT Positive- Patient
Infected Negative |
|------------------|--------|---------------------------------|--------------------------------|----------------------------------------------------|--------------------------------|----------------------------------------------|-------------------------------------------------------------------------------------------------|
| FS | S | 90.9% (50/55)
80.0-97.0 | 97.6% (531/544)
95.9-98.7 | 88.7% (55/62)
78.1-95.3 | 98.5% (529/537)
97.1-99.4 | 3/1 | 3/8 |
| | A | 100% (47/47)
92.5-100 | 96.1% (743/773)
94.5-97.4 | 96.8% (61/63)
89.0-99.6 | 97.9% (741/757)
96.6-98.8 | 6/0 | 8/16 |
| | Total | 95.1% (97/102)
88.9-98.4 | 96.7% (1274/1317)
95.6-97.6 | 92.8% (116/125)
86.8-96.7 | 98.1% (1270/1294)
97.3-98.8 | 9/1 | 11/24 |
| FU1 | S | 75.9% (41/54)2
62.4-86.5 | 97.3% (506/520)
95.5-98.5 | 77.0% (47/61)3
64.5-86.8 | 98.2% (505/513)
97.0-99.3 | 71/34 | 4/8 |
| | A | 91.3% (42/46)
79.2-97.6 | 96.9% (694/716)
95.4-98.1 | 83.9% (52/62)4
72.3-92.0 | 98.3% (688/700)
97.0-99.1 | 90/47 | 5/12 |
| | Total5 | 83.0% (83/100)
74.2-88.2 | 97.1% (1200/1236)
96.0-98.0 | 80.5% (99/123)
72.4-87.1 | 98.4% (1193/1213)
97.4-99.0 | 161/81 | 9/20 |
| MS | S | 95.8% (92/96)
89.7-98.3 | 89.9% (356/396)
86.5-92.7 | 95.5% (105/110)
89.7-98.5 | 92.9% (355/382)
89.9-95.3 | 1/0 | 16/27 |
| | A | 88.2% (15/17)
63.6-98.5 | 95.9% (162/169)
91.7-98.3 | 89.5% (17/19)
66.9-98.7 | 97.0% (162/167)
93.2-99.0 | 1/0 | 2/5 |
| | Total | 94.7% (107/113)
88.8-98.0 | 91.7% (518/565)
89.1-93.8 | 94.6% (122/129)
89.1-97.8 | 94.2% (517/549)
91.9-96.0 | 2/0 | 18/326 |
| MU1 | S | 95.8% (91/95)
89.6-98.8 | 86.5% (340/393)
82.7-89.7 | 95.4% (104/109)
89.6-98.5 | 89.4% (339/379)
85.9-92.4 | 20/10 | 28/40 |
| | A | 88.2% (15/17)
63.6-98.5 | 94.7% (161/170)
90.2-97.6 | 89.5% (17/19)
66.9-98.7 | 95.8% (161/168)
91.6-98.3 | 16/3 | 5/7 |
| | Total | 94.6% (106/112)
88.7-98.0 | 89.0% (501/563)
86.1-91.5 | 94.5% (121/128)
89.1-97.8 | 91.4% (500/547)
88.7-93.6 | 36/13 | 33/477 |
| Total8 | | 92.0% (393/427)
89.1-94.4 | 94.9% (3493/3681)
94.1-95.6 | 90.7% (458/505)
87.8-93.1 | 96.6% (3480/3603)
95.9-97.1 | 208/95 | 71/123 |

Tawe 1: BDProbeTec ET CT Results vs. Culture and Patient Infected Sieuds

1 Comparison cultures for female and male urine specifical and male urethral swab specimens, respectively,

² With A.C. two final indeetminates reported (instead of false negative), resulting in increase in sensitivity from 7.3 to 96.9%

With AC, wo final indexeminates reported instead of false negative, resulting in increase in somitively from 77.0% v81.4% and decrease in specificity from 98.4% to 98.1%
With AC, one final indeterminate reported (insealting in increase in sensitivity from 83.9% to 8.2% and decrease in specificity from 93.3% b98.2%.

5 With AC, female urine sensitivity for culture were 85.7% and 96.8%, respectively; and for patient infected status were 8.3% and 98.1%, respectively

6 13 of 16 of the AMP1 urine positives were confirmed by AMP2 testing.

7 14 of 30 of the AMP1 urine positives were confirmed by AMP2 testing.

8 With AC, total sensitivity and specificity for culture were 92.7% and for patient infected status were 91.4% and 96.5%, respectively

Note Separate performance characteristics were collected from pregant females. Sensibity and specificity compared o patient infected status for female swals and urines were 94.4% (17/18) , 98.4% (122/124) and 83.3% (15/18) , 100% (120/120), respectively.

9

| Specimen
Type | S/A | Compared to Culture | | Compared to Patient Infected Status | | # Indeterminate
Initial/Final | AMP1 Positive in either
specimen type /
BDPT Positive- Patient
Infected Negative |
|------------------|--------|------------------------------|--------------------------------|-------------------------------------|--------------------------------|----------------------------------|-------------------------------------------------------------------------------------------|
| | | Sensitivity
95% C.I. | Specificity
95% C.I. | Sensitivity
95% C.I. | Specificity
95% C.I. | | |
| FS | S | 95.8% (46/48)2
85.7-99.5 | 98.7% (545/552)
97.4-99.5 | 96.1% (49/51)3
86.5-99.5 | 99.3% (545/549)
98.1-99.8 | 3/1 | 1/4 |
| | A | 97.1% (34/35)
85.1-99.9 | 99.2% (770/776)
98.3-99.7 | 97.4% (37/38)
86.2-99.9 | 99.6% (770/773)
98.9-99.9 | 5/0 | 1/3 |
| | Total4 | 96.4% (80/83)
89.8-99.2 | 99.0% (1315/1328)
98.3-99.5 | 96.6% (86/89)
90.5-99.3 | 99.5% (1315/1322)
98.9-99.8 | 8/1 | 2/7 |
| FU1 | S | 84.8% (39/46)
71.1-93.7 | 99.2% (527/531)
98.1-99.8 | 83.7% (41/49)
70.3-92.7 | 99.6% (526/528)
98.6-100 | 79/38 | 0/2 |
| | A | 88.2% (30/34)
72.5-96.7 | 99.0% (713/720)
98.0-99.6 | 86.5% (32/37)
71.2-95.5 | 99.3% (712/717)
98.4-99.8 | 75/48 | 1/5 |
| | Total | 86.3% (69/80)
76.7-92.9 | 99.1% (1240/1251)
98.4-99.6 | 84.9% (73/86)
75.5-91.7 | 99.4% (1238/1245)
98.8-99.8 | 154/86 | 1/7 |
| MS5 | S | 98.4% (187/190)
95.5-99.7 | 94.8% (290/306)
91.6-97.0 | 98.4% (187/190)
95.5-99.7 | 94.8% (290/306)
91.6-97.0 | 1/0 | 16/16 |
| MU1,6 | S | 97.9% (185/189)
94.7-99.4 | 94.4% (286/303)
91.2-96.7 | 97.9% (185/189)
94.7-99.4 | 94.4% (286/303)
91.2-96.7 | 28/15 | 14/17 |
| Total | | 96.1% (521/542)
94.1-97.6 | 98.2% (3131/3188)
97.7-98.6 | 95.8% (531/554)
93.8-97.4 | 98.5% (3129/3176)
98.2-99.0 | 191/102 | 33/47 |

Table 2: BDProbeTec ET GC Results vs. Culture and Patient ...rected Status

1 Comparison cultures for female and male urine performed on endocervical and male urethral swab specimens, respectively.

2With AC one indeterminate reported (instead of false negative), resulting in increase in sensitivity from 95.8 to 97.9%

3With AC, one indeterminate reported (instead of false negative), resulting in increase in sensitivity from 96.1 to 98.0%

1 With AC, female swabs sensitivity and specificity for culture were 97.6% and 99.0%, respectively, and for patient infected status were 97.8% and 99.5%, respectively

• Data from swab specimens collected from 187 asymptomatic males were insufficient number (4) of infected patients to alequately determine performance characteristics.

· Data from wine speciment collected from 188 asymptomatic males were insufficient number (4) of infected patients to adequately determine performance characteristics.

Note: Separate characteritics vere calculated from pregant females. Sensibily and specificity and specificity composed o patient infected stans for finale swas and urines were 100% (2/2) , 98.6% (137/139) and 100% (2/2) , 98.5% (133/135), respectively.

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Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV - 4 1999

Ms. Colleen Rohrbeck Regulatory Affairs Associate Becton Dickinson Microbiology Systems 7 Loveton Circle Sparks. Maryland 21152

K984631 Re:

Trade Name: BDProbeTec™ ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assay BDProbeTec™ ET Chlamydia trachomatis Amplified DNA Assay Regulatory Class: II, I Product Code: LSL, MKZ Dated: August 10, 1999 Received: August 11, 1999

Dear Ms. Rohrbeck:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Butman

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

Enclosure

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Page 1 of 1

510(k) Number (if known): K984631

Device Name: BDProbeTec™ ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assay BDProbeTec™ ET Chlamydia trachomatis Amplified DNA Assay

Indications For Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubose

finical Laboratory Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________