(200 days)
Not Found
No
The device description details a DNA amplification and detection assay based on fluorescence measurements and a predetermined threshold value. While it mentions an "automated algorithm" for reporting results, this appears to be a simple comparison against a fixed threshold, not indicative of AI/ML. There are no mentions of AI, DNN, or ML in the document, nor is there a description of training or test sets for an AI/ML model.
No.
This device is an in vitro diagnostic (IVD) assay designed for the detection of Trichomonas vaginalis DNA to aid in the diagnosis of trichomoniasis, not for direct treatment or therapy.
Yes
The "Intended Use" section explicitly states that the assay "is indicated for use with asymptomatic and symptomatic females to aid in the diagnosis of trichomoniasis." This directly indicates its role in diagnosing a medical condition.
No
The device description clearly outlines the use of physical reagents (microwells containing primers, probes, nucleotides, enzymes) and a hardware system (BD Viper™ System) for amplification and detection. While software is involved in analyzing the fluorescent signals and reporting results, the core of the device is a combination of hardware and chemical components.
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 used for the "direct, qualitative detection of Trichomonas vaginalis DNA" in various female specimens to "aid in the diagnosis of trichomoniasis." This clearly indicates that the device is intended for use in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes.
- Device Description: The description details the components of the assay (reagents, microwells, enzymes) and how it works to detect target DNA using amplification and fluorescence. This is consistent with the technology used in many IVD tests.
- Specimen Types: The assay is designed to test "clinician-collected female endocervical swab specimens, patient-collected vaginal swab specimens, and female urine specimens." These are all types of human specimens commonly used in IVD testing.
- Performance Studies: The document includes detailed information about clinical performance characteristics (sensitivity and specificity) and reproducibility studies, which are standard requirements for demonstrating the analytical and clinical validity of an IVD.
- Predicate Device: The mention of a "Predicate Device(s)" (K102911; APTIMA Trichomonas vaginalis Assay) is a strong indicator that this device is being compared to an already cleared IVD, a common practice in the regulatory pathway for new IVDs.
All of these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BD ProbeTec™ Trichomonas vaginalis (TV) 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 Trichomonas vaginalis DNA in clinician-collected female endocervical swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and female urine specimens. The assay is indicated for use with asymptomatic and symptomatic females to aid in the diagnosis of trichomoniasis.
Product codes
OUY
Device Description
The BD ProbeTec Trichomonas vaginalis (TV) Q* Amplified DNA Assay (TVQ Assay) is based on the simultaneous amplification and detection of target DNA using amplification primers and fluorescently-labeled detector probes. 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, prewarmed 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 Trichomonas vaginalis 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 TV target DNA, a second labeled oligonucleotide is incorporated in each reaction Control (EC) oligonucleotide is labeled with a different dye than that used for detection of the TV 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 target-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 swab specimens, patient-collected vaginal swab specimens, female urine specimens.
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)
Clinical Performance Characteristics:
First void urine specimens, clinician-collected endocervical swab specimens, and self-collected (in a clinical setting) vaginal swab specimens were collected from 1,222 compliant female subjects attending family planning, OB/GYN, and sexually transmitted disease clinics at seven geographically diverse clinical sites in North America. Specimens were collected from subjects presenting with symptoms of trichomoniasis (symptomatic) or from subjects during routine visits to their healthcare provider (asymptomatic). Subjects were excluded from the data analysis due to collection site workflow, opting to withdraw from the study after initially consenting, transport/handling/storage errors, informed consent issues, subjects failing to meet the inclusion/exclusion criteria, collection errors, shipping errors, instrument errors, operating condition excursions or labeling errors. Therefore, the final data analysis included 735 compliant subjects for urine specimens, 832 compliant subjects for vaginal specimens, and 995 compliant subjects for endocervical specimens.
For each compliant subject, clinical specimens were collected in the following order: (1) a first void urine, (2) a patient-collected vaginal swab, (3) three clinician-collected vaginal swabs, and (4) an endocervical swab. The three clinician collected vaginal swabs were used for reference and discrepant testing. The first two of these were randomized, one swab was tested for the Wet Mount (reference method) and the other swab was used for the InPouch TV Culture (reference method). The third swab was used for testing using a commercially available NAAT. The aliquot of neat urine, the self-collected vaginal swab, and the endocervical swab were tested on the BD Viper System in extracted mode with the TVO assay.
All sensitivity and specificity calculations were based on the total number of BD ProbeTec TVQ Assay results for endocervical, vaginal, and urine specimens, as compared to a composite reference method. The initial instrument error rate during the clinical study was 0.1%, or 3 indeterminate results out of 2568 tests. The final error rate after repeat testing was performed on indeterminate results was 0.04%, or 1 indeterminate result out of 2568 tests.
Reproducibility:
Reproducibility of the BD Viper System using the BD ProbeTec TVQ Assay was evaluated at three test sites on one BD Viper System per site. Each site was provided with four identical reproducibility panels, each of which consisted of samples prepared using either Vaginal Matrix in O Swab Diluent or urine matrix. Each panel member was either left unspiked (0x), or was spiked with known amounts of TV organism (ATCC strain 30001) at 0.3x, 1x, and 3x LOD for each respective specimen matrix. Three replicates of each panel member were tested every day for five days on each BD Viper System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical Performance:
- Neat Urine (Asymptomatic): Sensitivity 93.1% (27/29), Specificity 99.6% (259/260)
- Neat Urine (Symptomatic): Sensitivity 96.4% (80/83), Specificity 98.1% (356/363)
- Neat Urine (Total): Sensitivity 95.5% (107/112), Specificity 98.7% (615/623)
- Vaginal (Asymptomatic): Sensitivity 93.5% (29/31), Specificity 99.0% (309/312)
- Vaginal (Symptomatic): Sensitivity 100.0% (85/85), Specificity 99.0% (406/410)
- Vaginal (Total): Sensitivity 98.3% (114/116), Specificity 99.0% (715/722)
- Endocervical (Asymptomatic): Sensitivity 92.2% (47/51), Specificity 99.1% (450/454)
- Endocervical (Symptomatic): Sensitivity 98.8% (82/83), Specificity 99.8% (406/407)
- Endocervical (Total): Sensitivity 96.3% (129/134), Specificity 99.4% (856/861)
- All Specimen Types Combined (Asymptomatic): Sensitivity 92.8% (103/111), Specificity 99.2% (1018/1026)
- All Specimen Types Combined (Symptomatic): Sensitivity 98.4% (247/251), Specificity 99.0% (1168/1180)
- All Specimen Types Combined (Overall): Sensitivity 96.7% (350/362), Specificity 99.1% (2186/2206)
Reproducibility (Agreement):
- Vaginal (Zero): 100.0% (89/89)
- Vaginal (High Negative (0.3X LOD)): 43.3% (39/90)
- Vaginal (Low Positive (1X LOD)): 96.7% (87/89)
- Vaginal (High Positive (3X LOD)): 100.0% (90/90)
- Urine Matrix (Zero): 100.0% (90/90)
- Urine Matrix (High Negative (0.3X LOD)): 39.3% (35/89)
- Urine Matrix (Low Positive (1X LOD)): 92.1% (82/89)
- Urine Matrix (High Positive (3X LOD)): 100.0% (90/90)
Predicate Device(s)
APTIMA Trichomonas vaginalis Assay (K102911)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3860
Trichomonas vaginalis nucleic acid assay.(a)
Identification. ATrichomonas vaginalis nucleic acid assay is a device that consists of primers, probes, enzymes, and controls for the amplification and detection of trichomonas nucleic acids in endocervical swabs, vaginal swabs, and female urine specimens, from women symptomatic for vaginitis, cervicitis, or urethritis and/or to aid in the diagnosis of trichomoniasis in asymptomatic women. The detection of trichomonas nucleic acids, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of trichomoniasis caused byTrichomonas vaginalis .(b)
Classification. Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Nucleic Acid Amplification Assays for the Detection ofTrichomonas vaginalis; Guideline for Industry and Food and Drug Administration Staff.” See § 866.1(e) for information on obtaining this document.
0
510(k) Summary BD ProbeTec"M Trichomonas Vaginalis (TV) Q* Amplified DNA Assay
| Applicant | BD Diagnostic Systems
7 Loveton Circle
Sparks, MD 21152 |
|--------------------------------|-------------------------------------------------------------------------------|
| Establishment Registration No. | 1119779 |
| Contact Person | Emily Howard
tel. 410-316-4428
fax. 410-316-4041
Emily_Howard@bd.com |
| Summary Date | August 15, 2013 |
| Proprietary Name | BD ProbeTecTM Trichomonas vaginalis (TV) Qx Amplified
DNA Assay |
| Generic Name | DNA probe, nucleic acid amplification, Trichomonas vaginalis |
| Classification | Class II |
| Classification Name | Trichomonas vaginalis nucleic acid amplification test system |
| Regulation Number | 21 CFR 866.3860 |
| Product Code | OUY |
| Predicate Device | APTIMA Trichomonas vaginalis Assay (K102911) |
Device Description
The BD ProbeTec Trichomonas vaginalis (TV) Q* Amplified DNA Assay (TVQ Assay) is based on the simultaneous amplification and detection of target DNA using amplification primers and fluorescently-labeled detector probes. 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, prewarmed 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 Trichomonas vaginalis 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.
1
In addition to the fluorescent probe used to detect amplified TV target DNA, a second labeled oligonucleotide is incorporated in each reaction Control (EC) oligonucleotide is labeled with a different dye than that used for detection of the TV 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 target-specific signals to report results as positive, negative, or EC failure.
Intended Use
The BD ProbeTec™ Trichomonas vaginalis (TV) 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 Trichomonas vaginalis DNA in clinician-collected female endocervical swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and female urine specimens. The assay is indicated for use with asymptomatic and symptomatic females to aid in the diagnosis of trichomoniasis.
Summary and Principles of Operation
When used with the BD Viper System, the BD ProbeTec TV 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, TV DNA is then detected by Strand Displacement Amplification (SDA) of the specific target sequence in the presence of a fluorescently-labeled detector probe.
Analytical Performance Characteristics
Limit of Detection (Analytical Sensitivity)
The Limit of Detection (LOD) for the TV Q* Assay on the BD Viper System was determined for two strains of T. vaginalis (one Metronidazole-sensitive and one Metronidazole-resistant) by diluting in specimen matrices (vaginal swab, endocervical swab, and urine) and in clean BD O* Swab Diluent to create an LOD panel consisting of six target levels of organism. For each strain and target level, twenty replicates of each panel member were tested on different BD Viper Systems for a total of 60 replicates. LOD was confirmed using 20 replicates at the estimated LOD for each matrix type. The LOD for the TV Q* Assay in clean BD Q* Swab Diluent was determined to be 54.5 and 55.5 trichomonads/mL for ATCC Strains 30001 and 50143. respectively. The LOD for urine and swab matrices are presented in Table 1. The TV Q* Assay on the BD Viper System in extracted mode could detect with ≥95% proportion positive four additional ATCC strains (30237, 50144, 30184, and 30185) in urine matrix and three ATCC strains (30185, 30237, and 50144) in vaginal swab specimen matrix at a concentration of 122,1 TV/mL. ·
2
| Specimen Type | ATCC Strain | LOD
(TV/mL) |
|---------------|-------------|----------------|
| Neat Urine | 30001 | 109.7 |
| | 50143 | 108.2 |
| Vaginal | 30001 | 74.4 |
| | 50143 | 88.4 |
| | 30184* | 152.8 |
| Endocervical | 30001 | 64.8 |
| | 50143 | 76.2 |
Table 1: LoD Estimates for TV Q* Assay
*LOD for T. vaginalis ATCC strain 30184 was determined in vaginal swab specimen matrix only.
·
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Analytical Specificity
The DNA from 54 organisms was extracted on the BD Viper System and tested with the BD ProbeTec TV Q Amplified DNA Assay. All potential cross-reactive species were tested at approximately ≥ 1x106 CFU/mL (bacteria and yeast), ≥ 1x106 vp/mL (viral particles), or organisms/mL (viruses and pathogens), except where noted. Results are summarized in Table 2.
| Organism | |
|---|---|
| Acinetobacter baumannii | HPV-18 |
| Actinomyces israelii | Human Immunodeficiency Virus 1 (HIV-1) |
| Atopobium vaginae | Klebsiella oxytoca |
| Bacteroides fragilis | Lactobacillus acidophilus |
| Bifidobacterium bifidum | Lactobacillus jensenii |
| Campylobacter jejuni | Lactobacillus vaginalis |
| Candida albicans | Listeria monocytogenes |
| Candida glabrata | Mobiluncus curtisii |
| Candida parapsilosis | Moraxella catarrhalis (Branhamella sp.) |
| Candida tropicalis | Mycobacterium smegmatis |
| Chlamydia trachomatis | Mycoplasma genitalium |
| Clostridium difficile | Mycoplasma hominis |
| Clostridium perfringens | Neisseria gonorrhoeae |
| Corynebacterium genitalium biovar 1 | Pentatrichomonas hominis1 |
| Cryptococcus neoformans | Peptostreptococcus anaerobius |
| Enterobacter aerogenes | Prevotella bivia |
| Enterobacter cloaceae | Proteus mirabilis |
| Enterococcus faecalis | Pseudomonas aeruginosa |
| Escherichia coli | Staphylococcus aureus, non-protein A |
| Fusobacterium nucleatum | Staphylococcus aureus, protein-A producing |
| Gardnerella vaginalis | Staphylococcus epidermidis |
| Haemophilus ducreyi | Staphylococcus saprophyticus |
| Herpes Simplex Virus Type 1 | Streptococcus pyogenes (Group A) |
| Herpes Simplex Virus Type 2 | Streptococcus agalactiae (Group B) |
| HPV-6 | Trichomonas tenax |
| HPV-11 | Ureaplasma urealyticum |
| HPV-16 | Veillonella parvula |
Table 2: Potential Cross-Reactants
I Tested at 3.39x10' organisms/mL
It was determined that Trichomonas tenax is a cross-reactant at levels above 1.0 x 10° organisms/mL of the TVQ Assay when tested on the BD Viper System. There were no other organisms found to cross-react with the TVQ Assay when tested on the BD Viper System.
4
Interfering Substances
Potential interfering substances which may be encountered in endocervical, vaginal, and urine specimens were tested in the absence and presence of TV target (223.2 trichomonads/mL from ATCC Strain 30001 in Vaginal Specimens and 165 trichomonads/mL from ATCC Strain 50143 in female urine specimens) and tested with the BD ProbeTec TV Q* Amplified DNA Assay on the BD Viper System. Results are summarized in Table 3.
| Interpretation | Swab | Urine matrix |
|---|---|---|
| No interference | Whole Blood (≤ 60%) | Phenazopyridine Hydrochloride |
| observed at levels | Seminal Fluid | Whole Blood (≤ 1% v/v) |
| listed | Mucus | Acidic urine (pH 5.0) |
| Over the counter vaginal | Alkaline urine (pH 9.0) | |
| products and contraceptives | Horomone pool | |
| Hemorrhoidal cream | Analgesic pool | |
| Prescription vaginal treatments | Antibiotics | |
| Leukocytes (1x106 cells/mL) | Bilirubin | |
| Intravaginal hormones | Mucus | |
| Albumin (≤ 1mg/mL) | ||
| Glucose | ||
| Semen (5% v/v) | ||
| Over the counter deodorant spray | ||
| and powder | ||
| Leukocytes (2.5x106 cells/mL) | ||
| May cause Extraction | Blood (> 60%) | Not applicable |
| Control (EC) failures | ||
| May cause false | Not applicable | Not applicable |
| negative results |
POTENTIAL INTERFERING SUBSTANCES TABLE 3:
5
Clinical Performance Characteristics
First void urine specimens, clinician-collected endocervical swab specimens, and self-collected (in a clinical setting) vaginal swab specimens were collected from 1,222 compliant female subjects attending family planning, OB/GYN, and sexually transmitted disease clinics at seven geographically diverse clinical sites in North America. Specimens were collected from subjects presenting with symptoms of trichomoniasis (symptomatic) or from subjects during routine visits to their healthcare provider (asymptomatic). Subjects were excluded from the data analysis due to collection site workflow, opting to withdraw from the study after initially consenting, transport/handling/storage errors, informed consent issues, subjects failing to meet the inclusion/exclusion criteria, collection errors, shipping errors, instrument errors, operating condition excursions or labeling errors. Therefore, the final data analysis included 735 compliant subjects for urine specimens. 832 compliant subjects for vaginal specimens, and 995 compliant subjects for endocervical specimens.
For each compliant subject, clinical specimens were collected in the following order: (1) a first void urine, (2) a patient-collected vaginal swab, (3) three clinician-collected vaginal swabs, and (4) an endocervical swab. The three clinician collected vaginal swabs were used for reference and discrepant testing. The first two of these were randomized, one swab was tested for the Wet Mount (reference method) and the other swab was used for the InPouch TV Culture (reference method). The third swab was used for testing using a commercially available NAAT. The aliquot of neat urine, the self-collected vaginal swab, and the endocervical swab were tested on the BD Viper System in extracted mode with the TVO assay.
All sensitivity and specificity calculations were based on the total number of BD ProbeTec TVQ Assay results for endocervical, vaginal, and urine specimens, as compared to a composite reference method. Sensitivity and specificity by specimen type (comparing the TVO Assay with the composite reference method) are presented in Table 4. The initial instrument error rate during the clinical study was 0.1%, or 3 indeterminate results out of 2568 tests. The final error rate after repeat testing was performed on indeterminate results was 0.04%. or 1 indeterminate result out of 2568 tests.
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TVQ ASSAY VS COMPOSITE REFERENCE RESULT CULTURE OF INPOUCH TV TABLE 4: CULTURE AND WET MOUNT (BY SPECIMEN TYPE AND SYMPTOMATIC STATUS)
| | Specimen
Type | Status | n | Sensitivity | 95% C.I. | Specificity | 95% C.I. |
|-----------------------------------|------------------|--------|-----------------|------------------|-------------------|------------------|----------------|
| | Neat Urine | A | 289 | 93.1% (27/29) | (78.0%, 98.1%) | 99.6% (259/260) | (97.9%, 99.9%) |
| | | S | 446 | 96.4% (80/83) | (89.9%, 98.8%) | 98.1% (356/363) | (96.1%, 99.1%) |
| | | Total | 735 | 95.5% (107/112)A | (90.0%, 98.1%) | 98.7% (615/623)B | (97.5%, 99.3%) |
| Vaginal | A | 343 | 93.5% (29/31) | (79.3%, 98.2%) | 99.0% (309/312) | (97.2%, 99.7%) | |
| | S | 495 | 100.0% (85/85) | (95.7%, 100.0%) | 99.0% (406/410) | (97.5%, 99.6%) | |
| | Total | 838 | 98.3% (114/116) | (93.9%, 99.5%) | 99.0% (715/722)C | (98.0%, 99.5%) | |
| Endocervical | A | 505 | 92.2% (47/51) | (81.5%, 96.9%) | 99.1% (450/454) | (97.8%, 99.7%) | |
| | S | 490 | 98.8% (82/83) | (93.5%, 99.8%) | 99.8% (406/407) | (98.6%, 100.0%) | |
| | Total | 995 | 96.3% (129/134) | (91.6%, 98.4%) | 99.4% (856/861)D | (98.6%, 99.8%) | |
| All Specimen
Types
Combined | A | 1137 | 92.8% (103/111) | (86.4%, 96.3%) | 99.2% (1018/1026) | (98.5%, 99.6%) | |
| | S | 1431 | 98.4% (247/251) | (96.0%, 99.4%) | 99.0% (1168/1180) | (98.2%, 99.4%) | |
| | Overall | 2568 | 96.7% (350/362) | (94.3%, 98.1%) | 99.1% (2186/2206) | (98.6%, 99.4%) | |
.
A = asymptomatic, S = symptomatic
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A frequency distribution of the initial MaxRFU values for the TVQ Assay with an assay cutoff of 125 MaxRFU is shown in Figure A.
Image /page/7/Figure/1 description: The image is a bar chart showing the frequency of MaxRFU values. The x-axis represents the MaxRFU ranges, and the y-axis represents the frequency. The highest frequency is observed in the 0-49 range, with a value of 2182. There is also a notable frequency in the >=800 range, with a value of 344.
FREQUENCY DISTRIBUTION OF MAXRFU FOR THE TVQ ASSAY (ALL SPECIMEN FIGURE A: TYPES)
.
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Reproducibility
Reproducibility of the BD Viper System using the BD ProbeTec TVQ Assay was evaluated at three test sites on one BD Viper System per site. Each site was provided with four identical reproducibility panels, each of which consisted of samples prepared using either Vaginal Matrix in O Swab Diluent or urine matrix, Each panel member was either left unspiked (0x), or was spiked with known amounts of TV organism (ATCC strain 30001) at 0.3x, 1x, and 3x LOD for each respective specimen matrix. Three replicates of each panel member were tested every day for five days on each BD Viper System. A summary of the reproducibility data for the TVQ Assay is summarized in Table 5.
| | | | | Within Run | | Between Run
Within Day | | Between Day
Within Site | | Between Site | | |
|----------------------|-----------------------------|-------------------|--------------------|------------|--------|---------------------------|--------|----------------------------|--------|--------------|--------|--------|
| Specim
en
type | Panel | Agreement | 95% CI | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Vaginal | Zero | 100.0%
(89/89) | (95.9%,
100.0%) | 3.89 | 4.02 | 103.53 | 2.01 | 51.64 | 0.92 | 23.57 | 4.69 | 120.60 |
| | High Negative
(0.3X LOD) | 43.3%
(39/90) | (33.6%,
53.6%) | 795.66 | 814.68 | 102.39 | 136.97 | 17.21 | 287.34 | 36.11 | 190.15 | 23.90 |
| | Low Positive
(IX LOD) | 96.7%
(87/89) | (90.7%,
98.9%) | 1632.07 | 457.83 | 28.05 | 0.00 | 0.00 | 0.00 | 0.00 | 110.13 | 6.75 |
| | High Positive
(3X LOD) | 100.0%
(90/90) | (95.9%,
100.0%) | 1756.68 | 297.78 | 16.95 | 0.00 | 0.00 | 104.51 | 5.95 | 260.45 | 14.83 |
| Urine
Matrix | Zero | 100.0%
(90/90) | (95.9%,
100.0%) | 8.70 | 11.33 | 130.18 | 0.00 | 0.00 | 0.00 | 0.00 | 8.29 | 95.33 |
| | High Negative
(0.3X LOD) | 39.3%
(35/89)* | (29.8%,
49.7%) | 976.96 | 913.87 | 93.54 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| | Low Positive
(IX LOD) | 92.1%
(82/89)* | (84.6%,
96.1%) | 1574.67 | 681.14 | 43.26 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| | High Positive
(3X LOD) | 100.0%
(90/90) | (95.9%,
100.0%) | 1822.52 | 364.46 | 20.00 | 0.00 | 0.00 | 0.00 | 0.00 | 172.88 | 9.49 |
Table 5: Summary of Reproducibility Data on the BD Viper System for the TVQ Assay
- Four non-reportable results were due to extraction control failures which caused a reduction in the full number of replicates at one test site.
Conclusion:
The analytical and clinical study results for the BD ProbeTec Trichomonas vaginalis (TV) Q* Amplified DNA Assay support the determination of substantial equivalence in accordance with the intended use as stated in the product labeling.
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Image /page/9/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 23, 2013
EMILY HOWARD REGULATORY AFFAIRS SPECIALIST BECTON, DICKINSON AND COMPANY 7 LOVETON CIRCLE SPARKS MD 21152
Re: K130268
Trade/Device Name: BD ProbeTec"™ Trichomonas vaginalis (TV) Q* Amplified DNA Assav Regulation Number: 21 CFR 866.3860 Regulation Name: Trichomonas vaginalis nucleic acid amplification test system Regulatory Class: II Product Code: OUY Dated: August 12, 2013 Received: August 13, 2013
Dear Ms. Howard:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Sally 緑◎jvat -S
Sally Hojvat, M.Sc., Ph.D. Director, Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure .
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Indications for Use
510(k) Number (if known): K130268
Device Name: BD ProbeTec™ Trichomonas vaginalis (TV) Q* Amplified DNA Assay
Indications for Use:
The BD ProbeTec™ Trichomonas vaginalis (TV) 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 Trichomonas vaginalis DNA in clinician-collected female endocervical swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and female urine specimens. The assay is indicated for use with asymptomatic females to aid in the diagnosis of trichomoniasis.
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 Center for Devices and Radiological Health (CDRH)
Tamara V. Feldblyum -S 2013.08.21 1 1:06:01 -04'00'
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