(79 days)
Not Found
No
The device description details a chemical and biological process for DNA amplification and detection via a lateral-flow strip with visual interpretation of colored lines. There is no mention of computational analysis, algorithms, or machine learning for result interpretation or any other function.
No
This device is an in vitro diagnostic test designed for the detection and differentiation of HSV-1 and HSV-2 DNA, which aids in the diagnosis of infection, rather than providing direct therapy or treatment.
Yes.
The "Intended Use / Indications for Use" section explicitly states that "The AmpliVue® HSV 1+2 Assay is an in vitro diagnostic test" and "The test is intended for use as an aid in diagnosis of HSV infection in symptomatic patients."
No
The device is an in vitro diagnostic test that involves physical components like tubes, reagents, and a lateral-flow strip cassette for sample processing, amplification, and detection. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The AmpliVue® HSV 1+2 Assay is an in vitro diagnostic test for the direct, qualitative detection and differentiation of Herpes Simplex Virus 1 (HSV-1) and Herpes Simplex Virus 2 (HSV-2) DNA in cutaneous or mucocutaneous lesion specimens from symptomatic patients."
This statement clearly identifies the device as an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The AmpliVue® HSV 1+2 Assay is an in vitro diagnostic test for the direct, qualitative detection and differentiation of Herpes Simplex Virus 1 (HSV-1) and Herpes Simplex Virus 2 (HSV-2) DNA in cutaneous or mucocutaneous lesion specimens from symptomatic patients. The test is intended for use as an aid in diagnosis of HSV infection in symptomatic patients.
Warning: The AmpliVue HSV 1+2 Assay is not FDA cleared for use with cerebrospinal fluid (CSF). The assay is not intended for prenatal screening.
Product codes (comma separated list FDA assigned to the subject device)
OQO
Device Description
The AmpliVue HSV 1+2 Assay consists of three major steps: 1) specimen preparation, 2) isothermal Helicase-Dependent Amplification (HDA) of target amplicons specific to HSV-1 and HSV-2, and 3) detection of the amplified DNA by target-specific hybridization probes via a colorimetric reaction on a lateral-flow strip which is embedded in a self-contained disposable cassette to prevent amplicon contamination.
Specimen preparation involves one simple dilution step in which specimens in viral transport medium are diluted 80-fold in Dilution Tubes.
The diluted samples are transferred into a 0.2 mL Amplification Tube containing lyophilized HDA reagents. Incubation at 64°C for 45 minutes results in the release of the HSV DNA and subsequent isothermal amplification of the target sequence. The amplified DNA is detected by a set of specific detection probes included in the Amplification Tube: HSV-1 target hybridizes to two specific probes labeled with Biotin (BioTEG) and Digoxigenin (DIG) and HSV-2 target hybridizes to two specific probes labeled with Biotin (BioTEG) and Fluorescein isothiocyanate (FITC). A competitive internal control (IC) is included in the Amplification Tube to monitor inhibitory substances in clinical samples, reagent failure or device failure. The IC target is amplified by HSV-2 specific primers and hybridizes to the biotin-labeled HSV-2 probe and a 1C specific probe labeled with 2,4-dinitrophenyl (DNP-TEG).
Detection of the amplified DNA with specific probes is achieved by Type III BEStTM cassettes. The self-contained Type III BESTM cassettes carry lateral-flow DNA detection strips coated with anti-DNP antibodies (C line), anti-DIG antibodies (T1 line) and anti-FITC antibodies (T2 line). HSV-1 amplicon with BioTEG and DIG-labeled probes is captured by anti-DIG antibodies at the TI-Line and HSV-2 amplicon with BioTEG and FITC-labeled probes is captured by anti-FITC antibodies at the T2-Line, while the IC amplicon with BioTEG and DNP-labeled probes is captured by anti-DNP antibodies at the C-Line. The amplicon-probe complexes captures the streptavidin-conjugated color particles for visualization and the test result is shown as colored lines that are visually read.
A positive result for HSV-1 (detection of HSV-1 DNA) is reported when the T1 line is visible through the detection window of the cassette, while a positive result for HSV-2 (detection of HSV-2 DNA) is reported when the T2 line is visible through the detection window of the cassette. A positive result for both HSV-2 (detection of both HSV-1 and HSV-2 DNA) is reported when both the T1 line and the T2 line are visible through the detection window of the cassette. A negative result (no detection of HSV-2 DNA) is reported when only the C line is displayed. The assay result is regarded as invalid when the T1 line, T2 line and C line are not present and the assay should be repeated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cutaneous or mucocutaneous lesion specimens (skin lesion, genital - penis, anorectal, genital - vaginal/cervical, nares, ocular, oral lesion and 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)
Reproducibility:
The reproducibility of the AmpliVue® HSV 1+2 Assay was evaluated at three test sites using a panel consisting of four panel members: HSV 1+2 High Negative; HSV-1 Low Positive; HSV-2 Low Positive; and HSV 1+2 Moderate Positive members. The HSV-1 Low Positive member served as a HSV-2 Negative member and the HSV-2 Low Positive member served as a HSV-1 Negative member. The panel members were prepared in HSV Negative Matrix that consisted of a pool of HSV negative cheek swabs in M4 medium. HSV Negative Matrix was spiked with quantified HSV 1 and 2 viral stocks at pre-determined TCID50 concentrations. The HSV viral stock was diluted in the HSV Negative Matrix to three (3) different concentration levels, defined as High Negative member (0.3 x LoD), Low Positive member (1 x LoD) and Moderate Positive member (3 x LoD level).
Each run tested the four member panel of four members in triplicate and also included three each of HSV-1 + HSV-2 positive control, and negative control. Two (2) operators per test site each carried out one run of the four member panel plus controls per test day for five (5) days using one lot of the AmpliVue® HSV 1+2 Assay.
Repeatability:
For the Precision/Within Laboratory Repeatability study, a blinded four-member panel consisting of medium positive and low positive, high negative 3x, 1x, ≤0.3x LoD, respectively) and negative HSV-1 and HSV-2 samples were tested in triplicate by two (2) operators, twice a day (2X) for twelve (12) days on all three instruments (triplicate testing x 2 operators x 12 days = 72 results per level for each virus). Positive and negative controls were run in triplicate with each test run.
Level of Detection (LoD):
A Limit of Detection (LoD) study was performed to evaluate the analytical sensitivity of AmpliVue HSV 1+2 Assay using a two representative viral strains of HSV-1 (McIntyre & HF) and two representative strains of HSV-2 (G & MS). Quantified (TCID5/mL) cultures of the HSV-1 and HSV-2 strains were serially diluted to five (5) concentrations in HSVnegative matrix pools and tested in replicates of ten (10) on three reagent lots. The observed LoD of a HSV strain was determined as the lowest concentration level that had a positivity rate of ≥95%. The observed limit of detection of HSV-1 and HSV-2 were determined to be 1.1 x 105 TCID50/mL and 1.1 x 104 TCID50/mL, respectively.
Analytical Specificity/Cross-Reactivity:
A study was performed to evaluate the performance of the AmpliVue® HSV 1+2 Assay in the presence of eighty-nine (89) microorganisms that might be found in lesion specimens. The panel members were obtained from suppliers as purified genomic DNA (GD) or quantified cultures (QC), or prepared in house (IHC) by growing each organism and quantifying the culture. Each potentially interfering or cross-reactive microorganism was tested in three (3) replicates the presence of negative matrix or 3x LoD HSV-2. Clinically relevant levels of viruses and bacteria are typically 10 cfulml or higher for bacteria and 10 pfu/ml or higher for viruses. Purified and quantified DNA or RNA was used for seven (7) of the microorganisms. For these microorganisms 106 copies per ml (cp/ml) or higher was used. None of the eighty-nine (89) microorganisms that might be found in lesion specimens interfere or cross-react with the assay.
Interfering Substances:
This study was performed to evaluate potential interference with Ampli Vue HSV 1+2 Assay with a panel of thirty-three (33) substances and five different viral transport media and microorganisms from cross reactivity panel that may be present in clinical specimens. The study was carried out in the presence of HSV-1 and HSV-2 at 3 x LoD to evaluate potential interference to the detection of the HSV target. The study was also carried out in the absence of HSV to evaluate potential interference to the detection of internal control of AmpliVue HSV 1+2 Assay. Each potential interfering substance was tested in triplicate. No interference was observed in the presence of the potential interfering substances tested.
Viral Transport Media:
The performance of the AmpliVue HSV 1+2 Assay was assessed with Remel M5, Remel M4RT, Bartels VTM, and BD Universal Viral Transport (UVT)/ Copan UTM. Each medium was tested after spiking with HSV-1 HF and HSV-2 G strain to a final concentration of approximately 3 x LoD to determine if the viral transport media interferes with the detection of HSV targets in positive samples. The media were tested in the absence of HSV-2 (medium only) to see if the viral transport media interfere with the detection of the internal control in negative samples. There was no interference observed with the Remel M4RT, Remel M5, Bartels VTM, and BD UVT/Copan UTM media for the detection of HSV-1 and HSV- 2 target or the internal control.
Cross-Reactivity Panel Members:
The performance of the AmpliVue HSV 1+2 Assay was characterized by testing the eighty-nine (89) microorganisms that were evaluated for analytical specificity and cross reactivity in the presence of HSV-1 HF and HSV-2 G at 3 x LoD separately to see if the presence of these organisms interferes with the detection of HSV targets. Each panel member was tested in triplicate. None of the cross reactivity panel members interfered with the detection of HSV-1 and HSV-2 targets.
Specimen Stability:
A study was performed to confirm the stability of HSV-1 and HSV-2 in viral transport media in accordance with recommended storage and handling specifications of each medium tested. The five media described above were spiked with HSV-1 or HSV-2 at 3 x LoD and stored at 2 - 8°C or -70°C. The media was tested by AmpliVue HSV 1+2 Assay at multiple time points. Based on this study at 3x LoD, HSV-1 and HSV-2 are stable in all five (5) media for 7 days at 2 - 8°C, and for 34 days at -70°C.
Competitive Inhibition:
The performance of the AmpliVue HSV 1+2 Assay was assessed for competitive interference using simulated samples in two studies mimicking co-infections. The first study used simulated samples with one target at a concentration near the LoD (3 x LoD) and the other target at higher concentrations (30x LoD to 3000 x LoD). The second study used simulated samples that had equal concentrations of HSV-1 virus and HSV-2 virus (3 x LoD to 3000 x LoD). In the first study competitive inhibition was not observed with simulated samples containing one target at a concentration near the LoD (3 x LoD) and the other target at up to 300 x LoD. However, competitive inhibition was observed for both HSV-1 and HSV-2 with simulated samples containing one target at a concentration near the LoD (3 x LoD) and the other target at 3000 x LoD. In the second study competitive inhibition was not observed with simulated samples containing equal concentrations of HSV-1 virus and HSV-2 virus, from 3 x LoD to 3000 x LoD.
Carry-Over and Cross Contamination:
Test results confirm that carry-over and cross contamination does not occur with AmpliVue HSV 1+2 Assay. High HSV-1 (HSV-2) positive samples were tested in series alternating with negative samples. In order to challenge the device, cultured and quantified viral stock served as high positive sample. HSV-1 HF (7.96 x 108 TCID30mL) and HSV-2 G (2.27 x 10' TCIDs6/mL) viral stocks were used directly without dilution, for the highest concentration available. Remel M4 viral transport media was used as negative sample. Ten (10) replicates of negative sample together with assay controls were run by two (2) operators to confirm that negative samples (Remel M4 viral transport media) generate a negative result 100% of the time. Five (5) replicates of high-concentration positive and negative samples were tested in a series, alternating sample types. All HSV-1 and HSV-2 high positive samples gave positive results and all the negative samples gave HSV negative results.
Clinical Performance:
The performance of the AmpliVue HSV 1 + 2 Assay was evaluated at five geographically diverse locations within the United States. A total of one thousand three hundred fifty-five (1355) specimens from symptomatic male and female patients were tested. Patient population ranged from ≤ 5 years to ≥ 60 years. The swab specimens have been categorized as cutaneous (skin lesion, genital - penis), or mucocutaneous (anorectal, genital - vaginal/cervical, nares, ocular, oral lesion and urethral). Nineteen (19) tests were considered invalid and were removed from the performance analysis. The reference ELVIS viral culture used in this study was unable to detect co-infected specimens. Due to this, if a specimen was positive for HSV-2 it was removed from the calculation of the HSV-1 clinical performance. Two hundred eleven (211) specimens identified as HSV-2 positive by ELVIS have been removed from the initial one thousand three hundred thirty-six (1336) specimens. The data below is for the remaining one thousand one hundred twenty-five (1125) specimens.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Reproducibility (HSV-1):
HSV-1 Low Positive: Overall Rate of Detection 99%, Overall Percent Agreement 99%, 95% Confidence Interval 94% - 100%
HSV 1+2 Moderate Positive: Overall Rate of Detection 100%, Overall Percent Agreement 100%, 95% Confidence Interval 96% - 100%
Positive HSV-1+2 Positive Control: Overall Rate of Detection 100%, Overall Percent Agreement 100%, 95% Confidence Interval 96% - 100%
Negative Control: Overall Rate of Detection 0%, Overall Percent Agreement 100%, 95% Confidence Interval 96% - 100%
Reproducibility (HSV-2):
HSV-2 Low Positive: Overall Rate of Detection 100%, Overall Percent Agreement 100%, 95% Confidence Interval 96% - 100%
HSV 1+- 2 Moderate Positive: Overall Rate of Detection 100%, Overall Percent Agreement 100%, 95% Confidence Interval 96% - 100%
HSV-1 Low Positive: Overall Rate of Detection 0%, Overall Percent Agreement 100%, 95% Confidence Interval 96% - 100%
HSV-1+2 Positive Control: Overall Rate of Detection 100%, Overall Percent Agreement 100%, 95% Confidence Interval 96% - 100%
Negative Control: Overall Rate of Detection 0%, Overall Percent Agreement 100%, 95% Confidence Interval 96% - 100%
Repeatability (HSV-1):
HSV-1 Low Positive: Rate of Detection 72/72, Overall Percent Agreement 100%, 95% Confidence Interval 95 - 100%
HSV 1+2 Moderate Positive: Rate of Detection 72/72, Overall Percent Agreement 100%, 95% Confidence Interval 95 - 100%
HSV-1 Negative Sample: Rate of Detection 0/72, Overall Percent Agreement 100%, 95% Confidence Interval 95 - 100%
HSV-1+2 Positive Control: Rate of Detection 72/72, Overall Percent Agreement 100%, 95% Confidence Interval 95 - 100%
Assay Negative Control: Rate of Detection 0/72, Overall Percent Agreement 100%, 95% Confidence Interval 95 - 100%
Repeatability (HSV-2):
HSV-2 Low Positive: Rate of Detection 72/72, Overall Percent Agreement 100%, 95% Confidence Interval 95 - 100%
HSV-1+2 Moderate Positive: Rate of Detection 72/72, Overall Percent Agreement 100%, 95% Confidence Interval 95 - 100%
HSV-2 Negative Sample: Rate of Detection 0/72, Overall Percent Agreement 100%, 95% Confidence Interval 95 – 100%
HSV-1+2 Positive Control: Rate of Detection 72/72, Overall Percent Agreement 100%, 95% Confidence Interval 95 – 100%
Assay Negative Control: Rate of Detection 0/72, Overall Percent Agreement 100%, 95% Confidence Interval 95 - 100%
Clinical Performance (Combined Sites - HSV-1 Cutaneous Lesions):
Sensitivity: 100% (95% CI: 88.6% to 100%)
Specificity: 97.1% (95% CI: 94.6% to 98.5%)
Clinical Performance (Combined Sites – HSV-1 Mucocutaneous Lesions):
Sensitivity: 94.9% (95% CI: 90.3% to 97.4%)
Specificity: 96.5% (95% CI: 94.8% to 97.7%)
Clinical Performance (Combined Sites - HSV-2 Cutaneous Lesions):
Sensitivity: 98.3% (95% CI: 91.0% to 99.7%)
Specificity: 95.6% (95% CI: 92.8% to 97.3%)
Clinical Performance (Combined Sites – HSV-2 Mucocutaneous Lesions):
Sensitivity: 97.4% (95% CI: 93.4% to 99.0%)
Specificity: 95.8% (95% CI: 94.2% to 97.0%)
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.
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).
0
510(K) SUMMARY
The following information is provided as required by 21 CFR § 807.87 for Quidel Corporation 510(k) premarket notification for the AmpliVue® HSV 1+2 Assay. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.
Applicant:
Quidel Corporation 10165 McKellar Court San Diego, California 92121 Telephone: 858-552-7910 Fax: 858-646-8045
Contact Information:
Ronald H. Lollar, Senior Director Clinical and Regulatory Affairs 2005 East State Street Suite 100 Athens, Ohio 45701 740-589-3300 - Corporate number 740-589-3373 - Desk phone 740-593-8437 - Fax Ron.Lollar@quidel.com
Date of preparation of 510(k) summary:
December 30, 2013
Device Name:
| Trade name: | AmpliVue® HSV 1+2 Assay |
|---|---|
| Classification name: | Herpes Simplex Virus Nucleic Acid Amplification Assay |
| Product Code: | OQO |
| Class: | II |
| Regulation: | 21 CFR 866.3305 Herpes simplex virus serological assays |
| Panel: | Microbiology (83) |
Substantial Equivalency
The AmpliVue® HSV 1+2 Assay is substantially equivalent in principle to the currently marketed IsoAmp HSV Assay for the direct, qualitative detection of Herpes Simplex Virus 1 (HSV-1) and
l
1
Herpes Simplex Virus 2 (HSV-2) nucleic acids. The clinical performance of the AmpliVue™ HSV 1+2 Assay for the differentiation of Herpes Simplex Virus 1 (HSV-1) and Herpes Simplex Virus 2 (HSV-2) nucleic acids was compared with the ELVIS® HSV ID and D³ Typing Test System which is the gold standard/reference method i.e., cell culture using an enzyme linked virus inducible system.
| Features | AmpliVue® HSV 1+2 Assay
Quidel Corporation | IsoAmp® HSV Assay
BioHelix Corporation
(K111951) |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The AmpliVue® HSV 1+2
Assay is an in vitro diagnostic
test for the direct, qualitative
detection and differentiation of
Herpes Simplex Virus 1
(HSV-1) and Herpes Simplex
Virus 2 (HSV-2) DNA in
cutaneous or mucocutaneous
lesion specimens from
symptomatic patients. The test
is intended for use as an aid in
diagnosis of HSV infection in
symptomatic patients.
Warning: The AmpliVue
HSV 1+2 Assay is not FDA
cleared for use with
cerebrospinal fluid (CSF). The
assay is not intended for
prenatal screening. | The IsoAmp® HSV Assay is
an in vitro diagnostic test for
the direct, qualitative detection
of the Herpes Simplex Virus
(HSV-1 + HSV-2) DNA in
male and female genital and
oral lesions. The test is
intended for use as an aid in
diagnosis of HSV infection in
symptomatic patients.
Warning: The IsoAmp®HSV
Assay is not FDA cleared for
use with cerebrospinal fluid
(CSF). The assay does not
provide specific typing
information to differentiate
HSV-1 and HSV-2. The assay
is not intended to be used for
prenatal screening. |
| Assay Results | Qualitative | Qualitative |
| Detection of HSV-1 and
HSV-2 | Yes | Yes |
| Typing of HSV-1 and HSV-2 | Yes | No |
| Methodology | HDA (Helicase-Dependent
Amplification) | HDA (Helicase-Dependent
Amplification) |
| Packaging | Supplied as a kit; 16 tests per
kit
- Amplification-related Kit
Components (ARKC) - Non-amplification related
Kit Components (NKC) | The product is supplied as two
separate labeled boxes. - Amplification-related Kit
Components (ARKC) - Non-amplification related
Kit Components (NKC) |
| Kit Reagent Storage
Conditions | ARKC: 2°C to 8°C
NKC: 2°C to 30°C | ARKC: 60 years | 107 | 16 | 15.0% | 107 | 17 | 15.9% |
| Not provided | 1 | 1 | 100% | 1 | 0 | 0% |
| | Percent | 95% CI | | Percent | 95% CI | |
| Positive
Predictive Value | 87.1% | 81.3% to 91.3% | | 81.8% | 75.5% to 86.7% | |
| Negative
Predictive Value | 98.7% | 97.5% to 99.3% | | 99.5% | 98.6% to 99.8% | |
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| Combined Study - Mucocutaneous Prevalence by Specific Source | ||||||
|---|---|---|---|---|---|---|
| HSV- 1 | HSV-2 | |||||
| Source | Total # | Total Positive | Prevalence | Total # | Total Positive | Prevalence |
| Anorectal | 35 | 2 | 5.7% | 35 | 8 | 22.9% |
| Genital - | ||||||
| vaginal/cervical | 691 | 109 | 15.9% | 691 | 168 | 24.3% |
| Nasal | 16 | 5 | 31.3% | 16 | 2 | 12.5% |
| Ocular | 18 | 3 | 16.7% | 18 | 1 | 5.6% |
| Oral lesion | 165 | 54 | 32.7% | 165 | 2 | 1.2% |
| Urethral | 18 | 0 | N/A | 18 | 3 | 16.7% |
Clinical Performance
The performance of the AmpliVue HSV 1 + 2 Assay was evaluated at five geographically diverse locations within the United States. A total of one thousand three hundred fifty-five (1355) specimens from symptomatic male and female patients were tested. Patient population ranged from ≤ 5 years to ≥ 60 years. The swab specimens have been categorized as cutaneous (skin lesion, genital - penis), or mucocutaneous (anorectal, genital - vaginal/cervical, nares, ocular, oral lesion and urethral). Nineteen (19) tests were considered invalid and were removed from the performance analysis.
The reference ELVIS viral culture used in this study was unable to detect co-infected specimens. Due to this, if a specimen was positive for HSV-2 it was removed from the calculation of the HSV-1 clinical performance. Two hundred eleven (211) specimens identified as HSV-2 positive by ELVIS have been removed from the initial one thousand three hundred thirty-six (1336) specimens. The data below is for the remaining one thousand one hundred twenty-five (1125) specimens.
| Combined Sites - HSV-1 Cutaneous Lesions (N=340) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Reference | |||||||||||
| Method | ૭૨% Cl | ||||||||||
| POS | NEG | Total | Sensitivity | 100% | 88.6% | 100% | |||||
| AmpliVue HSV | POS | 30 | ರ | ਤੇ ਹੋ | Specificity | 97.1% | 94.6% | 98.5% | |||
| 1+2 Assay | NEG | 0 | 301 | 301 | |||||||
| Total | 30 | 310 | 340 |
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| Combined Sites – HSV-1 Mucocutaneous Lesions (N=785) | ||||||||
|---|---|---|---|---|---|---|---|---|
| Reference Method | 95% CI | |||||||
| POS | NEG | Total | Sensitivity | 94.9% | 90.3% | 97.4% | ||
| AmpliVue HSV | ||||||||
| 1+2 Assay | POS | 149 | 22 | 171 | Specificity | 96.5% | 94.8% | 97.7% |
| NEG | 8 | 606 | 614 | |||||
| Total | 157 | 628 | 785 |
The table below details the HSV-2 results for the one thousand three hundred thirty-six (1336) specimens.
| Combined Sites - HSV-2 Cutaneous Lesions (N=399) | ||||||||
|---|---|---|---|---|---|---|---|---|
| Reference Method | 95% CI | |||||||
| POS | NEG | Total | Sensitivity | 98.3% | 91.0% | 99.7% | ||
| AmpliVue HSV | ||||||||
| 1+2 Assay | POS | 58 | 15 | 73 | Specificity | 95.6% | 92.8% | 97.3% |
| NEG | 1 | 325 | 326 | |||||
| Total | 59 | 340 | 399 |
| Combined Sites – HSV-2 Mucocutaneous Lesions (N=937) | ||||||||
|---|---|---|---|---|---|---|---|---|
| Reference Method | 95% CI | |||||||
| POS | NEG | Total | Sensitivity | 97.4% | 93.4% | 99.0% | ||
| AmpliVue HSV | ||||||||
| 1+2 Assay | POS | 148 | 33 | 181 | Specificity | 95.8% | 94.2% | 97.0% |
| NEG | 4 | 752 | 756 | |||||
| Total | 152 | 785 | 937 |
Statement of Performance
The results of the analytical and clinical performance studies submitted in this pre-market notification are complete and demonstrate that the AmpliVue® HSV 1+2 Assay is substantially equivalent to the predicate device. The AmpliVue® HSV 1+2 Assay performs as well as the gold standard/reference method for the differentiation of Herpes Simplex Virus 1 (HSV-1) and Herpes Simplex Virus 2 (HSV-2) nucleic acids.
16
Image /page/16/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 26, 2014
QUIDEL CORPORATION RONALD H. LOLLAR SENIOR DIRECTOR, CLINICAL AND REGULATORY AFFAIRS 2005 EAST STATE STREET, SUITE 100 ATHENS, OH 45701 USA
Re: K140029
Trade/Device Name: AmpliVue™ HSV 1+ 2 Assay Regulation Number: 21 CFR §866.3305 Regulation Name: Herpes Simplex Virus Nucleic Amplification Assay Regulatory Class: II Product Code: OQO Dated: December 30, 2013 Received: January 6, 2014
Dear Mr. Lollar:
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 (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.
17
Page 2-Mr. Lollar
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.goy/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,
Stephen J. Lovell -S for
Sally A. 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
18
510(k) Number (if known): K140029
Device Name: AmpliVue® HSV 1+2 Assay
Indication for Use:
The AmpliVue® HSV 1+2 Assay is an in vitro diagnostic test for the direct, qualitative detection and differentiation of Herpes Simplex Virus 1 (HSV-1) and Herpes Simplex Virus 2 (HSV-2) DNA in cutaneous or mucocutaneous lesion specimens from symptomatic patients. The test is intended for use as an aid in diagnosis of HSV infection in symptomatic patients.
Warning: The AmpliVue HSV 1+2 Assay is not FDA cleared for use with cerebrospinal fluid (CSF). The assay is not intended for prenatal screening.
Prescription Use Over-The-Counter Use AND/OR X (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Stephen J. Lovell -S 2014.03.26 09:55:34 -04'00'