(81 days)
ELVIS HSV ID and D3 Typing Test System
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No
The device description details a fluorescence-based amplification and detection method with a simple threshold comparison and an automated algorithm for EC and target signals to report results. There is no mention of AI, ML, or complex pattern recognition beyond basic signal processing and comparison to a fixed threshold.
No
This device is a diagnostic assay designed to detect and differentiate Herpes Simplex virus DNA, aiding in the diagnosis of infections, rather than treating them.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the assays are "indicated for use with symptomatic individuals to aid in the diagnosis of anogenital HSV1 and HSV2 infections."
No
The device description clearly outlines physical components like microwells, reagents, enzymes, and the BD Viper™ System hardware used for amplification, detection, and thermal control. While software is involved in data analysis and reporting, the device is fundamentally a hardware-based diagnostic system with integrated software.
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 and differentiation of Herpes Simplex virus type 1 (HSV1) and Herpes Simplex virus type 2 (HSV2) DNA in clinician-collected external anogenital lesion specimens." This is a diagnostic test performed on a biological sample (specimen) taken from the human body.
- Device Description: The description details the use of reagents, amplification technology (SDA), and a system (BD Viper™) to analyze the DNA in the specimen. This is characteristic of an in vitro diagnostic test.
- Performance Studies: The document describes clinical performance studies comparing the device's results to a reference method (viral culture and typing) using human specimens. This is a standard requirement for demonstrating the performance of an IVD.
- Key Metrics: The document reports metrics like Sensitivity and Specificity, which are key performance indicators for diagnostic tests.
The definition of an In Vitro Diagnostic (IVD) is a medical device that is used to perform tests on samples such as blood, urine, and tissues to detect diseases or other conditions. This device clearly fits that description.
N/A
Intended Use / Indications for Use
The BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Q* Amplified DNA Assays, when tested with the BD ViperTM System in Extracted Mode. use Strand Displacement Amplification technology for the direct, qualitative detection and differentiation of Herpes Simplex virus type 1 (HSV1) and Herpes Simplex virus type 2 (HSV2) DNA in clinician-collected external anogenital lesion specimens. The assays are indicated for use with symptomatic individuals to aid in the diagnosis of anogenital HSV1 and HSV2 infections.
Warning: The BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Q Amplified DNA Assays (HSV Of Assays) are not FDA cleared for use with cerebrospinal fluid (CSF). The assays are not intended to be used for prenatal screening or for individuals under the age of 17 years.
Product codes (comma separated list FDA assigned to the subject device)
OQO
Device Description
The BD ProbeTec Herpes Simplex Viruses (HSV 1 & 2) Q* Amplified DNA Assays (HSV Q* Assays) are 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 for each HSV Q* Assay: 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 nocessary for anipinioused, intion endonuclease) that are required for SDA. The BD ViperTM 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 then sealed to prevent contamination and incubated in one of the two thermally-controlled fluorescent readers. The presence or absence of Herpes Simplex virus type 1 (HSV1) or Herpes Simplex virus type 2 (HSV2) 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 HSV1 or HSV2 target DNA, a second labeled oligonucleotide is incorporated in each reaction. The Extraction Control (EC) oligonucleotide is labeled with a different dve than that used for detection of the HSV I or HSV2 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
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Input Imaging Modality
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Anatomical Site
clinician-collected external anogenital lesion specimens
Indicated Patient Age Range
The assays are not intended to be used for individuals under the age of 17 years. (Implied: 17 years and older)
Intended User / Care Setting
Clinician-collected, family planning, OB/GYN, and sexually transmitted disease clinics
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Clinician-collected external anogenital lesion swab specimens were collected from 564 compliant male and female subjects attending family planning, OB/GYN, and sexually transmitted disease clinics at nine geographically diverse clinical sites in North America. Fiftysix subjects were excluded from the data analysis due to age requirement violations, antiviral use in the last 21 days, opting to withdraw from the study after initially consenting, transport errors, informed consent issues, failing to meet the inclusion criteria, collection errors, shipping errors, or labeling errors. Therefore, the final data analysis included 508 compliant subjects.
For each of the 508 compliant subjects, two swab specimens were collected from the external anogenital lesion. The first specimen collected was always the Universal Viral Transport specimen followed by the BD ProbeTec OF Collection Kit for Endocervical or Lesion Specimens (Q* Swab Diluent specimen). The UVT was aliquotted into a Q* Swab Diluent Tube (UVT in Q* Swab Diluent), and a cryovial (vial suitable for -70 ℃ storage), and the remaining UVT was sent to one of two laboratories for viral culture and typing. The Q Swab Diluent specimen and the UVT in Q Swab Diluent specimen were transported to one of the three BD Viper testing laboratories where they were tested using the BD ProbeTec HSV1 and HSV2 Q* Assays on the BD Viper System. The cryovial containing the UVT aliquot was sent to a laboratory for PCR testing.
All sensitivity and specificity calculations were based on the total number of BD ProbeTec HSV1 and HSV2 Q Assays results for Q Swab Diluent and UVT in Q Swab Diluent specimens, as compared to a commercially available viral culture and typing procedure as the reference method. A PCR method was also used for analysis of discrepant results from the ProbeTec HSV Q* Amplified DNA Assays and the reference culture and typing method.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Performance Characteristics:
Sample Size: 508 compliant subjects.
Study Type: Performance of BD ProbeTec HSV1 and HSV2 Q* Assays compared to viral culture and PCR for discrepant results.
Key Metrics for HSV1 Q Assay Performance Compared to Viral Culture (by specimen type):*
UVT in Qx Swab Diluent (n=312):
Sensitivity: 96.8% (60/62) with 95% C.I. (88.8% - 99.6%)
Specificity: 97.6% (244/250) with 95% C.I. (94.8% - 99.1%)
Qx Swab Diluent (n=308):
Sensitivity: 96.7% (59/61) with 95% C.I. (88.7% - 99.6%)
Specificity: 95.1% (235/247) with 95% C.I. (91.7% - 97.5%)
Key Metrics for HSV2 Q Assay Performance Compared to Viral Culture (by specimen type):*
UVT in Qx Swab Diluent (n=501):
Sensitivity: 98.4% (186/189) with 95% C.I. (95.4% - 99.7%)
Specificity: 83.7% (261/312) with 95% C.I. (79.1% - 87.6%)
Qx Swab Diluent (n=498):
Sensitivity: 98.4% (186/189) with 95% C.I. (95.4% - 99.7%)
Specificity: 80.6% (249/309) with 95% C.I. (75.7% - 84.8%)
Reproducibility (BD Viper System using BD ProbeTec HSV1 and HSV2 Q Assays):*
Evaluated at three test sites (two external, one internal) on one BD Viper System per site.
Two panels of simulated specimens (HSV1 and/or HSV2 viral particles seeded into Q* Swab Diluent or UVT in Q* Swab Diluent).
Viral particles spiked at 2-fold or 5-fold LOD.
Six replicates of each panel member tested daily for five days on each system.
HSV1 Q Assay Reproducibility Summary:*
Total Agreement with Expected Results ranging from 97.8% (92.2%-99.7% CI) to 100% (96%-100% CI) across different specimen types and target concentrations. MaxRFU mean and standard deviation also reported.
HSV2 Q Assay Reproducibility Summary:*
Total Agreement with Expected Results ranging from 95.9%-100% CI to 100% (96%-100% CI) across different specimen types and target concentrations. MaxRFU mean and standard deviation also reported.
Conclusions: The analytical and clinical study results support the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
HSV1 Q Assay Performance Compared to Viral Culture (by specimen type):*
UVT in Qx Swab Diluent: Sensitivity 96.8% (60/62), Specificity 97.6% (244/250)
Qx Swab Diluent: Sensitivity 96.7% (59/61), Specificity 95.1% (235/247)
HSV2 Q Assay Performance Compared to Viral Culture (by specimen type):*
UVT in Qx Swab Diluent: Sensitivity 98.4% (186/189), Specificity 83.7% (261/312)
Qx Swab Diluent: Sensitivity 98.4% (186/189), Specificity 80.6% (249/309)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ELVIS HSV ID and D3 Typing Test System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3305 Herpes simplex virus serological assays.
(a)
Identification. Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.(b)
Classification. Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).
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Image /page/0/Picture/2 description: The image shows the logo for BD, a medical technology company. The logo consists of a stylized human figure with outstretched arms, topped by a sun-like burst of rays. To the right of the figure are the letters "BD" in a bold, sans-serif font. Below the letters is the company's slogan, "Helping all people live healthy lives."
BD ProbeTec™ Herpes Simplex Viruses (HSV1 & 2) Q* Amplified DNA Assays
| Applicant | BD Diagnostic Systems
7 Loveton Circle
Sparks, MD 21152 | MAR 18 2011 |
|--------------------------------|-------------------------------------------------------------------------------------|-------------|
| Establishment Registration No. | 1119779 | |
| Contact Person | Thalia Charles
tel. 410-316-4145
fax. 410-316-4499
Thalia_E_Charles@bd.com | |
| Summary Date | March 14, 2011 | |
| Proprietary Name | BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Qx
Amplified DNA Assays | |
| Generic Name | DNA probe, nucleic acid amplification, Herpes Simplex virus | |
| Classification | Class II | |
| Classification Name | Herpes simplex virus serological assays | |
| Regulation Number | 21 CFR 866.3305 | |
| Product Code | OQO | |
| Predicate Device | ELVIS HSV ID and D3 Typing Test System | |
Device Description
The BD ProbeTec Herpes Simplex Viruses (HSV 1 & 2) Q* Amplified DNA Assays (HSV Q* Assays) are 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 for each HSV Q* Assay: 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 nocessary for anipinioused, intion 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 then sealed to prevent contamination and incubated in one of the two thermally-controlled fluorescent readers. The presence or absence of Herpes Simplex virus type 1 (HSV1) or Herpes Simplex virus type 2 (HSV2) DNA is determined by calculating the peak fluorescence (Maximum Relative
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Image /page/1/Picture/1 description: The image shows the logo for BD, a medical technology company. The logo consists of two parts: a symbol on the left and the letters "BD" on the right. The symbol is a stylized representation of a sun rising over a horizon, with a smiling face incorporated into the design. Below the letters "BD" is the tagline "Helping all people live healthy lives."
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 HSV1 or HSV2 target DNA, a second labeled oligonucleotide is incorporated in each reaction. The Extraction Control (EC) oligonucleotide is labeled with a different dve than that used for detection of the HSV I or HSV2 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™ Herpes Simplex Viruses (HSV 1 & 2) O* Amplified DNA Assays, when tested with the BD Viper™ System in Extracted Mode. use Strand Displacement Amplification technology for the direct, qualitative detection and differentiation of Herpes Simplex virus type 1 (HSV1) and Herpes Simplex virus type 2 (HSV2) DNA in clinician-collected external anogenital lesion specimens. The assays are indicated for use with symptomatic individuals to aid in the diagnosis of anogenital HSV1 and HSV2 infections.
Warning: The BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Q Amplified DNA Assays (HSV Of Assays) are not FDA cleared for use with cerebrospinal fluid (CSF). The assays are not intended to be used for prenatal screening or for individuals under the age of 17 years.
Summary and Principles of Operation
When used with the BD Viper System, the BD ProbeTec HSV Q* Amplified DNA Assays involve 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, HSV1 or HSV2 DNA is then detected by Strand Displacement Amplification (SDA) of either 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 HSV1 Q* Assay with HSV1 ATCC strain VR-539 in model matrix specimens when extracted on the BD Viper System were determined to be 23 viral particles/mL (vp/mL) in the Q Swab Diluent medium, and 85 vp/mL in the Universal Viral Transport medium (UVT). These values correspond to 7 TCID50/mL and 25 TCIDsy/mL,
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BD ProbeTec™ Herpes Simplex Viruses (HSV1 & 2) Q* Amplified DNA Assays
respectively. The Limits of Detection (LODs) for the HSV2 Q* Assay with HSV2 ATCC strain VR-734 in model matrix specimens when extracted on the BD Viper System were determined to be 84 vp/mL (35 TCIDss/mL) in the Q Swab Diluent medium and 635 vp/mL (262 TCIDs6/ml.) in the UVT medium. Evaluation of the HSV1 Q* Assay on the BD Viper System in extracted mode with three additional HSV1 strains gave LoD values between 6 and 14 vp/mL in clean Q* Swab Diluent and between 110 and 185 vp/mL in clean UVT. Evaluation of the HSV2 Q* Assay on the BD Viper System in extracted mode with one additional HSV2 strain gave an LOD of 34 vp/mL in clean Q* Swab Diluent and 380 vp/mL in clean UVT.
Analytical Specificity
The DNA from 57 organisms was extracted on the BD Viper System and tested with the BD ProbeTec HSV Q Amplified DNA Assays. All potential cross-reactive species were tested at approximately 1x108 Colony Forming Units/mL for bacteria and yeast or 1x106 Plaque Forming Units/mL or greater for viruses, except where noted. Results are summarized in Table 1.
| Table 1: Potential Cross-Reactants | |
|---|---|
| Actinomyces israelii | Human papillomavirus 161 |
| Adenovirus | Human papillomavirus 181 |
| Alcaligenes faecalis | Kingella kingae |
| Candida albicans | Klebsiella pneumoniae |
| Chlamydia trachomatis serovar H | Lactobacillus acidophilus |
| Chlamydia trachomatis serovar LGV-2 | Listeria monocytogenes |
| Clostridium perfringens | Mobiluncus mulieris |
| Corynebacterium genitalium | Moraxella lacunata |
| Cryptococcus neoformans | Mycobacterium tuberculosis1 |
| HHV-5 Cytomegalovirus (CMV)1 | Mycoplasma genitalium |
| Enterobacter cloacae | Neisseria gonorrhoeae |
| Enterococcus faecalis | Neisseria meningitidis |
| Enterococcus faecium | Propionibacterium acnes |
| Enterovirus (Echovirus 11)1 | Proteus vulgaris |
| HHV-4 Epstein Barr virus2 | Pseudomonas aeruginosa |
| Escherichia coli (strain K1) | Staphylococcus aureus |
| Gardnerella vaginalis | Staphylococcus epidermidis |
| Gemella haemolysans | Staphylococcus saprophyticus |
| Haemophilus ducreyi | Streptococcus agalactiae |
| Haemophilus influenzae | Streptococcus mitis |
| Hepatitis B Virus1 | Streptococcus pneumoniae |
| HHV-6 (Roseolovirus)1 | Streptococcus pyogenes |
| HHV-6B (Roseolovirus)1 | Treponema pallidum |
| HHV-7 (Roseolovirus)1 | Trichomonas vaginalis |
Table 1: Potential Cross-Reactants
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| HHV-8 (Rhadinovirus)1 | Varicella Zoster Virus (HHV-3)1 |
|---|---|
| Human Immunodeficiency Virus 1 (HIV-1)2 | Veillonella parvula |
| Human Immunodeficiency Virus 2 (HIV-2)2 | Herpes Virus Type 1 (HSV1)2* |
| Human papillomavirus 61 | Herpes Virus Type 2 (HSV2)2** |
| Human papillomavirus 111 |
4 Genomic DNA tested at 1x106 DNA copies/mL
2 Viruses tested at 1x10* viral particles/ml_
- Tested as a cross-reactant in the HSV2 Q* Assay only
** Tested as a cross-reactant in the HSVI Q* Assay only
Interfering Substances
Potentially interfering substances which may be encountered in external anogenital lession specimens were tested in the absence and presence of HSV1 and HSV2 targets (for HSV1 target, 69 vp/mL in Qx Swab Diluent and 255 vp/mL in UVT; for HSV2 target, 252 vp/mL in Qx Swab Diluent and 1905 vp/mL in UVT; these levels are 3 times each LOD) and tested with the BD ProbeTec HSV Q* Amplified DNA Assays on the BD Viper System. Results are summarized in Table 2.
| Interpretation | Q* Swab Diluent | UVT |
|---|---|---|
| Blood (2.5% v/v) | Blood (3.3% v/v) | |
| Seminal fluid (2.5% v/v) | Seminal fluid (3.3% v/v) | |
| Mucus (2.5% v/v) | Mucus (3.3% v/v) | |
| Feces (2.5%) | Feces (3.3%) | |
| Urine (2.5% v/v) | Urine (3.3% v/v) | |
| Cornstarch (2.5%) | Cornstarch (3.3%) | |
| Over the counter vaginal products | ||
| and contraceptives (2.5% v/v) | Over the counter vaginal products | |
| and contraceptives (3.3% v/v) | ||
| No interference observed | ||
| at levels listed | Over the counter cold sore products | |
| (2.5% v/v) | Over the counter cold sore products | |
| (3.3% v/v) | ||
| Hemorrhoidal cream (2.5% v/v) | Hemorrhoidal cream (3.3% v/v) | |
| Prescription vaginal and anti-viral | ||
| treatments (2.5% v/v) | Prescription vaginal and anti-viral | |
| treatments (3.3% v/v) | ||
| Leukocytes (1x106 cells/mL) | Leukocytes (1x106 cells/mL) | |
| 1x106 viral particles/mL HSV1 | ||
| (when tested in the HSV2 Q* assay) | 1x106 viral particles/mL HSV1 | |
| (when tested in the HSV2 Q* assay) | ||
| 1x106 viral particles/mL HSV2 | ||
| (when tested in the HSV1 Q* assay) | 1x106 viral particles/mL HSV2 | |
| (when tested in the HSV1 Q* assay) | ||
| May cause extraction control (EC) | ||
| failures | Not applicable | Not applicable |
| May cause false negative results | Not applicable | Not applicable |
Table 2: Potentially Interfering Substances
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BD ProbeTec™ Herpes Simplex Viruses (HSV1 & 2) Q* Amplified DNA Assays
Clinical Performance Characteristics
Clinician-collected external anogenital lesion swab specimens were collected from 564 compliant male and female subjects attending family planning, OB/GYN, and sexually transmitted disease clinics at nine geographically diverse clinical sites in North America. Subjects were classified as symptomatic if they presented with an external anogenital lesion that met the study inclusion/exclusion criteria and the physician suspected a herpes infection. Fiftysix subjects were excluded from the data analysis due to age requirement violations, antiviral use in the last 21 days, opting to withdraw from the study after initially consenting, transport errors, informed consent issues, failing to meet the inclusion criteria, collection errors, shipping errors, or labeling errors. Therefore, the final data analysis included 508 compliant subjects.
For each of the 508 compliant subjects, two swab specimens were collected from the external anogenital lesion. The first specimen collected was always the Universal Viral Transport specimen followed by the BD ProbeTec OF Collection Kit for Endocervical or Lesion Specimens (Q* Swab Diluent specimen). The UVT was aliquotted into a Q* Swab Diluent Tube (UVT in Q* Swab Diluent), and a cryovial (vial suitable for -70 ℃ storage), and the remaining UVT was sent to one of two laboratories for viral culture and typing. The Q Swab Diluent specimen and the UVT in Q Swab Diluent specimen were transported to one of the three BD Viper testing laboratories where they were tested using the BD ProbeTec HSV1 and HSV2 Q* Assays on the BD Viper System. The cryovial containing the UVT aliquot was sent to a laboratory for PCR testing.
All sensitivity and specificity calculations were based on the total number of BD ProbeTec HSV1 and HSV2 Q Assays results for Q Swab Diluent and UVT in Q Swab Diluent specimens, as compared to a commercially available viral culture and typing procedure as the reference method. A PCR method was also used for analysis of discrepant results from the ProbeTec HSV Q* Amplified DNA Assays and the reference culture and typing method.
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D ProbeTec™ Herpes Simplex Viruses (HSV1 & 2) Q* Amplified DNA Assays
Table 3: HSV1 Q* Assay Performance Compared to Viral Culture (by specimen type)
| Specimen
| Type | n1 | Sensitivity | 95% C.I. | Specificity | 95% C.I. |
|---|---|---|---|---|---|
| UVT in | |||||
| Qx Swab | |||||
| Diluent | 312 | 96.8% (60/62)3 | (88.8% - 99.6%) | 97.6% | |
| (244/250)4 | (94.8% - | ||||
| 99.1%) | |||||
| Qx Swab | |||||
| Diluent | 3082 | 96.7% (59/61)3 | (88.7% - 99.6%) | 95.1% | |
| (235/247)5 | (91.7% - | ||||
| 97.5%) |
' The reference viral culture used in this study was unable to detect co-infected specimen is negative for 'SV V is it types and The reference the number of samples used for HSV lanalysis equals the number of samples with a reference virtl culture typing result (501) minus the number of samples positive for HSV2 by the reference method (189).
4 A total of four Q Swab Diluent specimens were not included in the HSV1 analysis due to insufficient volume, aliquot error, or extraction error ..
3 Both subjects that were identified as positive for HSV I with viral culture were negative for HSVI with the HSVI Q* Assay and PCR. Both the M HSV Q* Assays and the PCR assay identified the subjects as positive for HSV2.
- There were six UVT in Q Swab Diluent specimens that were identified as negative for HSVI with viral culture but were positive for both the HSV1 Qx Assay and the PCR assay.
110 Y Q Thoughter of Swab Dilvent speciment that were identified as negative for HSVI with viral culture but were positive with the HSVI QV Assay. Seven of these specimens were also positive with the PCR assay.
Table 4: HSV2 Q* Assay Performance Compared to Viral Culture (by specimen type)
| Specimen
| Type | n | Performance Compared to Viral Culture | |||
|---|---|---|---|---|---|
| Sensitivity | 95% C.I. | Specificity | 95% C.I. | ||
| UVT in | |||||
| Qx | |||||
| Swab | |||||
| Diluent | 501 | 98.4% (186/189)6 | (95.4% - | ||
| 99.7%) | 83.7% | ||||
| (261/312)7,9 | (79.1% - | ||||
| 87.6%) | |||||
| Qx Swab | |||||
| Diluent | 498 | 98.4% (186/189)6 | (95.4% - | ||
| 99.7%) | 80.6% | ||||
| (249/309)8,9 | (75.7% - | ||||
| 84.8%) |
6 All three subjects that were identified as positive for HSV2 with viral culture were negative for USV1 All three subjects that were neemned as possions for ree subjects as positive for HSVI.
1 46 of the 51 HSV2 UVT in Q* Swab Diluent positive and viral culture negative were positive for HSV2 by PCR.
40 of the 60 HSV2 Q Swab Diluent positive specimens and viral culture negatives were positive for HSV2 by PCR.
49 to the of to Y L Q S Nat Diness: peach Assay in samples that were culture negative could indicate detection of nonviable viral particles.
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Frequency distributions of the initial MaxRFU values for the HSV1 Q Assay with an assay cutoff of 125 MaxRFU for specimens in each media type are shown in Figures A and B.
Image /page/6/Figure/4 description: The image is titled "Figure A: Frequency Distribution of MaxRFU for the HSV1 Q Assay, UVT in Q Swab Diluent". The title describes the contents of the figure, which is a frequency distribution of MaxRFU values for the HSV1 Q assay. The assay was performed using UVT in Q swab diluent.
Image /page/6/Figure/5 description: The image is a bar graph showing the frequency of MaxRFU values. The x-axis represents the MaxRFU ranges, and the y-axis represents the frequency. The bar graph shows that the highest frequency is in the 0-49 range, with a value of 246. There is also a notable frequency in the >=800 range, with a value of 60.
Figure B: Frequency Distribution of MaxRFU for the HSV1 Q* Assay, Q* Swab Diluent
Image /page/6/Figure/7 description: This bar graph shows the frequency of MaxRFU values. The x-axis represents the MaxRFU ranges, while the y-axis represents the frequency. The highest frequency is observed in the 0-49 range, with a value of 236. The frequency for the range >=800 is 60.
Frequency distributions of the initial MaxRFU values for the HSV2 Q Assay with an assay cutoff of 125 MaxRFU for specimens in each media type are shown in Figures C and D.
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Image /page/7/Picture/1 description: The image shows the logo for BD, a medical technology company. The logo consists of two parts: a graphic on the left and the letters "BD" on the right. The graphic features a stylized human figure with arms raised, surrounded by radiating lines, resembling a sun or starburst. Below the logo is the tagline "Helping all people live healthy lives".
Figure C: Frequency Distribution of MaxRFU for the HSV2 O' Assay, UVT in O* Swab Diluent
Image /page/7/Figure/4 description: The image is a bar graph showing frequency on the y-axis and MaxRFU on the x-axis. The x-axis is divided into categories: 0-49, 50-99, 100-124, 125-149, 150-199, 200-249, 250-349, 350-499, 500-799, and >=800. The frequencies for each category are 260, 4, 0, 0, 1, 0, 1, 1, 2, and 232 respectively.
Figure D: Frequency Distribution of MaxRFU for the HSV2 Q Assay, Q* Swab Diluent
Image /page/7/Figure/6 description: This bar graph shows the frequency of MaxRFU. The x-axis shows the MaxRFU ranges, and the y-axis shows the frequency. The bar graph shows that the frequency is highest for the 0-49 range, with a value of 251, and the >=800 range, with a value of 238.
Reproducibility
Reproducibility of the BD Viper System using the BD ProbeTec HSV1 and HSV2 Q* Assays was evaluated at three test sites (two external and one internal) on one BD Viper System per site. Two panels of simulated specimens were tested that were comprised of HSV (strain VR-539) and/or HSV2 (strain VR-734) viral particles seeded into either Q* Swab Diluent containing a swab (simulated Q* Swab Diluent) or UVT in Q* Swab Diluent (simulated UVT in Q* Swab Diluent specimen type). Viral particles were spiked into the simulated samples at 2-fold or 5-fold LOD. Uninoculated Q* Swab Diluent or UVT in Q* Swab Diluent was used for the negative samples. Six 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 HSV1 and HSV2 Q Assays is presented in Tables 7 and 8.
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Image /page/8/Picture/1 description: The image contains the BD logo. The logo consists of a stylized sun-like symbol with a human figure at the center, followed by the letters "BD" in bold, sans-serif font. Below the letters, there is a tagline that reads "Helping all people live healthy lives" in a smaller font size.
Table 7: Summary of Reproducibility Data on the BD Viper System for the HSV1 Q* Assay.
| Site #1 | Site #2 | Site #3 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Simulated | |||||||||||||||
| Specimen | |||||||||||||||
| Type | Targets | ||||||||||||||
| HSV1/HSV2 | |||||||||||||||
| (xLOD)** | Agreement | ||||||||||||||
| with | |||||||||||||||
| Expected | |||||||||||||||
| Results | Max | ||||||||||||||
| RFU | |||||||||||||||
| Mean | Max | ||||||||||||||
| RFU | |||||||||||||||
| StdDev | %CV | Agreement | |||||||||||||
| with | |||||||||||||||
| Expected | |||||||||||||||
| Results | Max | ||||||||||||||
| RFU | |||||||||||||||
| Mean | Max | ||||||||||||||
| RFU | |||||||||||||||
| StdDev | %CV | Agreement | |||||||||||||
| with | |||||||||||||||
| Expected | |||||||||||||||
| Results | Max | ||||||||||||||
| RFU | |||||||||||||||
| Mean | Max | ||||||||||||||
| RFU | |||||||||||||||
| StdDev | %CV | Total | |||||||||||||
| Agreement | |||||||||||||||
| with | |||||||||||||||
| Expected | |||||||||||||||
| Results | |||||||||||||||
| (%) | 95% | ||||||||||||||
| Confidence | |||||||||||||||
| Interval | |||||||||||||||
| UVT in | |||||||||||||||
| Q' Swab | |||||||||||||||
| Diluent | 0/0 | 30/30 | 2.2 | 6.7 | N/A* | 30/30 | 4.3 | 12.9 | N/A* | 30/30 | 0.7 | 2.2 | N/A* | 90/90 | |
| (100%) | 96% - | ||||||||||||||
| 100% | |||||||||||||||
| 2x/0 | 29/30 | 1432.6 | 447.6 | 31.2 | 30/30 | 1375.4 | 326.2 | 23.7 | 30/30 | 1474.5 | 307.9 | 20.9 | 89/90 | ||
| (98.9%) | 94% - | ||||||||||||||
| 100% | |||||||||||||||
| 0/2x | 30/30 | 3.8 | 10.9 | N/A* | 30/30 | 7.8 | 27.6 | N/A* | 30/30 | 7.3 | 10.7 | N/A* | 90/90 | ||
| (100%) | 96% - | ||||||||||||||
| 100% | |||||||||||||||
| 2x/5x | 29/30 | 1123.1 | 622.9 | 55.5 | 30/30 | 1144.9 | 397.7 | 34.7 | 30/30 | 1441.4 | 205.8 | 14.3 | 89/90 | ||
| (98.9%) | 94% - | ||||||||||||||
| 100% | |||||||||||||||
| 5x/2x | 30/30 | 1586.2 | 346.8 | 21.9 | 30/30 | 1531.5 | 165.4 | 10.8 | 30/30 | 1619.7 | 175.7 | 10.8 | 90/90 | ||
| (100%) | 96% - | ||||||||||||||
| 100% | |||||||||||||||
| Q' Swab | |||||||||||||||
| Diluent | 0/0 | 29/30 | 24.9 | 39.0 | N/A* | 29/30 | 15.5 | 84.7 | N/A* | 30/30 | 0.9 | 3.8 | N/A* | 88/90 | |
| (97.8%) | 92.2% - | ||||||||||||||
| 99.7% | |||||||||||||||
| 2x/0 | 30/30 | 1477.2 | 392.3 | 26.6 | 28/30 | 999.2 | 482.9 | 48.3 | 30/30 | 1276.7 | 396.0 | 31.0 | 88/90 | ||
| (97.8%) | 92.2%- | ||||||||||||||
| 99.7% | |||||||||||||||
| 0/2x | 30/30 | 12.3 | 23.7 | N/A* | 30/30 | 0.0 | 0.0 | N/A* | 30/30 | 0.3 | 0.8 | N/A* | 90/90 | ||
| (100%) | 96% - | ||||||||||||||
| 100% | |||||||||||||||
| 2x/5x | 30/30 | 1551.0 | 369.1 | 23.8 | 30/30 | 1395.1 | 144.3 | 10.3 | 30/30 | 1320.5 | 349.9 | 26.5 | 90/90 | ||
| (100%) | 96% - | ||||||||||||||
| 100% | |||||||||||||||
| 5x/2x | 30/30 | 1751.5 | 174.0 | 9.9 | 30/30 | 1441.8 | 214.8 | 14.9 | 30/30 | 1535.1 | 244.1 | 15.9 | 90/90 | ||
| (100%) | 96% - | ||||||||||||||
| 100% |
*The coefficient of variation (CV) is not a useful mean approaches 0, as the CV is very sensitive to small changes in the mean. ** HSV1 and HSV2 were spiked at either 2-fold (2x) or 5-fold (5x) the LOD.
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Image /page/9/Picture/1 description: The image shows the logo for BD, a global medical technology company. The logo consists of two parts: a stylized graphic on the left and the letters "BD" on the right. The graphic features a circle with a stylized human figure inside, with rays emanating from the top, resembling a sun. Below the logo, there is a tagline that reads "Helping all people live healthy lives" in a smaller font size.
Table 8: Summary of Reproducibility Data on the BD Viper System for the HSV2 QF Assay.
| Site #1 | Site #2 | Site #3 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Simulated | |||||||||||||||
| Specimen | |||||||||||||||
| Type | Targets | ||||||||||||||
| HSV1/HSV2 | |||||||||||||||
| (xLOD)** | Agreement | ||||||||||||||
| with | |||||||||||||||
| Expected | |||||||||||||||
| Results | Max | ||||||||||||||
| RFU | |||||||||||||||
| Mean | Max | ||||||||||||||
| RFU | |||||||||||||||
| StdDev | %CV | Agreement | |||||||||||||
| with | |||||||||||||||
| Expected | |||||||||||||||
| Results | Max | ||||||||||||||
| RFU | |||||||||||||||
| Mean | Max | ||||||||||||||
| RFU | |||||||||||||||
| StdDev | %CV | Agreement | |||||||||||||
| with | |||||||||||||||
| Expected | |||||||||||||||
| Results | Max | ||||||||||||||
| RFU | |||||||||||||||
| Mean | Max | ||||||||||||||
| RFU | |||||||||||||||
| StdDev | %CV | Total | |||||||||||||
| Agreement | |||||||||||||||
| with | |||||||||||||||
| Expected | |||||||||||||||
| Results | |||||||||||||||
| (%) | 95% | ||||||||||||||
| Confidence | |||||||||||||||
| Interval | |||||||||||||||
| UVT in | |||||||||||||||
| Q' Swab | |||||||||||||||
| Diluent | 0/0 | 29/29*** | 6.5 | 9.2 | N/A* | 30/30 | 5.2 | 16.4 | N/A* | 30/30 | 7.4 | 8.1 | N/A* | 89/89 | |
| (100%) | 95.9% - | ||||||||||||||
| 100% | |||||||||||||||
| 2x/0 | 30/30 | 6.8 | 9.8 | N/A* | 30/30 | 3.9 | 12.2 | N/A* | 30/30 | 14.4 | 13.5 | N/A* | 90/90 | ||
| (100%) | 96% - | ||||||||||||||
| 100% | |||||||||||||||
| 0/2x | 30/30 | 1768.6 | 390.0 | 22.0 | 30/30 | 1806.1 | 263.6 | 14.6 | 30/30 | 1910.6 | 236.5 | 12.4 | 90/90 | ||
| (100%) | 96% - | ||||||||||||||
| 100% | |||||||||||||||
| 2x/5x | 30/30 | 1946.5 | 246.8 | 12.7 | 30/30 | 1800.1 | 267.6 | 14.9 | 30/30 | 1965.1 | 171.7 | 8.7 | 90/90 | ||
| (100%) | 96% - | ||||||||||||||
| 100% | |||||||||||||||
| 5x/2x | 30/30 | 1866.1 | 319.9 | 17.1 | 30/30 | 1823.8 | 250.8 | 13.8 | 30/30 | 1861.2 | 224.8 | 12.1 | 90/90 | ||
| (100%) | 96% - | ||||||||||||||
| 100% | |||||||||||||||
| Q' Swab | |||||||||||||||
| Diluent | 0/0 | 29/29*** | 8.2 | 19.1 | N/A* | 30/30 | 0.4 | 2.2 | N/A* | 30/30 | 2.9 | 11.9 | N/A* | 89/89 | |
| (100%) | 95.9%- | ||||||||||||||
| 100% | |||||||||||||||
| 2x/0 | 30/30 | 11.2 | 23.6 | N/A* | 30/30 | 0.2 | 1.3 | N/A* | 30/30 | 2.2 | 4.0 | N/A* | 90/90 | ||
| (100%) | 96% - | ||||||||||||||
| 100% | |||||||||||||||
| 0/2x | 29/29*** | 2007.1 | 219.4 | 10.9 | 30/30 | 1679.5 | 331.1 | 19.7 | 30/30 | 1757.3 | 289.2 | 16.5 | 89/89 | ||
| (100%) | 95.9%- | ||||||||||||||
| 100% | |||||||||||||||
| 2x/5x | 29/29*** | 2028.3 | 230.6 | 11.4 | 30/30 | 1787.5 | 327.9 | 18.3 | 30/30 | 1882.7 | 342.1 | 18.2 | 89/89 | ||
| (100%) | 95.9%- | ||||||||||||||
| 100% | |||||||||||||||
| 5x/2x | 29/29*** | 1960.7 | 254.7 | 13.0 | 30/30 | 1756.2 | 286.7 | 16.3 | 30/30 | 1762.7 | 350.3 | 19.9 | 89/89 | ||
| (100%) | 95.9% - | ||||||||||||||
| 100% |
*The coefficient of variation (CV) is not a useful measure when the mean approaches 0, as the CV is very sensitive to small changes in the mean. ** HSV1 and HSV2 were spiked at either 2-fold (2x) or 5-fold (5x) the LOD.
*** Non-reportable results due to a BD Viper Instrument error which caused a reduction in the full number of replicates.
Conclusions:
The analytical and clinical study results for the BD ProbeTec Herpes Simplex Viruses (HSV) Q* Amplified DNA Assays support the determination of substantial equivalence in accordance with the intended use as stated in the product labeling.
10
Image /page/10/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of a stylized bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Cemer - WO66-0609 Silver Spring, MD 20993-0002
BD Diagnostic Systems c/o Thalia Charles Regulatory Affairs Specialist 7 Loveton Circle Sparks, MD 21152
MAR 1 8 201
Re: K103798
| Trade/Device Name: | BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Qˣ Amplified DNA Assays |
|---|---|
| Regulation Number: | 21 CFR §866.3305 |
| Regulation Name: | Herpes Simplex Virus Nucleic Acid Amplification Assay |
| Regulatory Class: | Class II |
| Product Code: | OQO |
| Dated: | December 22, 2010 |
| Received: | December 27, 2010 |
Dear Ms. Charles:
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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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
11
Page 2 - Thalia Charles
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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely yours,
TaqcAtyms
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
12
Indications for Use
510(k) Number (if known): K103798
BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Q* Amplified DNA Assays Device Name:
Indications For Use:
The BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Q* Amplified DNA Assays, when tested with the BD Viper™ System in Extracted Mode, use Strand Displacement Amplification technology for the direct, qualitative detection and differentiation of Herpes Simplex virus type 1 (HSV1) and Herpes Simplex virus type 2 (HSV2) DNA in clinician-collected external anogenital lesion specimens. The assays are indicated for use with symptomatic individuals to aid in the diagnosis of anogenital HSV1 and HSV2 infections.
Warning: The BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Q* Amplified DNA Assays (HSV Q* Assays) are not FDA cleared for use with cerebrospinal fluid (CSF). The assays are not intended to be used for prenatal screening or for individuals under the age of 17 years.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR (21 CFR 807 Subpart C)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Uwe Schif
Division Sign-Off
Division Sign-Off
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Office of In Vitro Diagnostic Device Evaluation and Safety
k to3798 510(k)_