(298 days)
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No
The summary describes a standard immunoassay system and its performance characteristics. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is a qualitative diagnostic test for detecting antibodies to Herpes Simplex virus, which aids in diagnosis rather than providing therapy.
Yes.
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "as an aid for presumptively diagnosing Herpes Simplex 1 and 2." This directly indicates its role in diagnosis.
No
The device description explicitly states that the test system is comprised of a kit (which contains reagents and other physical components for the immunoassay) and the Luminex Corp instrument and software. This indicates the device includes hardware components (the instrument) in addition to software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of the presence or absence of human IgG class antibodies to Herpes Simplex virus I and 2 in human sera." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information about a person's health status (presence of antibodies to HSV).
- Device Description: The description details a "microparticle immunoassay system" and a "multiplexed immunoassay designed to simultaneously detect and distinguish IgG antibody to HSV 1 and/or 2 using recombinant HSV gG-1 and HSV gG-2 antigens." This is a typical description of an in vitro diagnostic test that analyzes biological samples for specific markers.
- Performance Studies: The document describes extensive performance studies using human serum samples to evaluate the test's accuracy (sensitivity, specificity, agreement with a predicate device) in different populations. This is a requirement for IVD devices to demonstrate their reliability for diagnostic purposes.
- Predicate Device: The mention of a "Predicate Device(s)" which is also an "Immunoblot IgG Test System" further confirms that this device is being compared to another IVD device used for similar diagnostic purposes.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Zeus Scientific, Inc. AtheNA Multi-Lyte HSV 1 & 2 IgG Test System is intended for the qualitative detection of the absence or presence of IgG class antibody to HSV 1 and HSV 2 in human sera. The test is intended to be used as as an aid in the presumptive diagnosis of diseases caused by exposure to Herpes Simplex Virus 1 and 2 in sexually active adults and expectant mothers. The performance of this assay has not been established for use in a pediatric population, neonates and immunocompromised patients.
Product codes (comma separated list FDA assigned to the subject device)
MXJ, MYF
Device Description
The AtheNA Multi-Lyte HSV 1 & 2 IgG Test System is a microparticle immunoassay system intended for the qualitative detection of distict IgG antibody to HSV 1 and/or HSV 2. The test is a multiplexed immunoassay designed to simultaneously detect and distinguish IgG antibody to HSV 1 and/or 2 using recombinant HSV gG-1 and HSV gG-2 antigens. The test system is comprised of the AtheNA Multi-Lyte HSV 1 & 2 kit and the Luminex Corp instrument and software.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Sexually active adults and expectant mothers. The performance of this assay has not been established for use in a pediatric population, neonates and immunocompromised patients.
Intended User / Care Setting
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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
27 known negative samples, confirmed by a commercially distributed ELISA assay were tested to establish the cut-off. Additionally, a minimum of 5 known positive samples, also confirmed by a commercially distributed ELISA assay were tested. The results of the known positive samples were ascertained to exceed the theoretical cut-off as well as the negative samples were ascertained to fall below the theoretical cut-off.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data Non-Clinical
- Establishment and Verification of Cut-off: 27 known negative samples, confirmed by a commercially distributed ELISA assay, were tested. A minimum of 5 known positive samples, also confirmed by a commercially distributed ELISA assay, were tested.
- Linearity: Two positive samples (one each for HSV1 and HSV 2) were tested neat and with two-fold serial dilutions using the AtheNA Multi-Lyte HSV 1 & 2 Test System. Results verify the linearity of the assay cut-off.
- Limits of Detection: Three (each) strongly positive samples were serially diluted and tested using the AtheNA Multi-Lyte HSV 1 & 2 test system and a commercially available ELISA test system. Results demonstrate that the AtheNA Multi_lyte HSV 1 & 2 test system has comparable limits of detection to the commercially available ELISA test system.
- Interfering Substances: Tested with Bilirubin, Albumin, Cholesterol, Triglycerides, Hemoglobin, Intralipid. Three samples each for HSV-1 and HSV-2 (positive, borderline, negative) were chosen. All samples showed less than a 20% change in signal with some exceptions for negative samples, but the qualitative outcome remained negative.
- Cross-Reactivity: Studies performed using sera HSV dual-negative by immunoblot testing and sero-positive to Measles, Mumps, EBV VCA, EBNA, Rubella, VZV, ANA, CMV, and Syphilis. No detectable cross-reactivity. Monoclonal antibodies from potential cross reactants (GONORRHEA, MONOBILUNCUS, BACTEROIDES, VAGINALIS, PAPILLOMA, TRACHOMATIS) also tested negative.
- Precision/Reproducibility: Study conducted with six samples (two clearly negative, two clearly positive, two near cut-off). Panel split into six aliquots and tested at three sites over three days. Each sample diluted twice and run in quadruplicate (8 results per day). Demonstrated intra-assay, inter-assay, and inter-laboratory precision.
Performance Data Clinical
- Expected Values (Prevalence):
- Sexually Active Adults: 317 patients (sera submitted for HSV 1 & 2 IgG antibodies) tested at three clinical sites. Overall observed prevalence: HSV-1 59.6%, HSV-2 28.1%.
- Expectant Mothers: 150 retrospective samples (50 from each trimester). Overall observed prevalence: HSV-1 66.7%, HSV-2 40.7%.
- Agreement Summaries:
- Performance in a Population of Sexually Active Adults: 317 prospective samples assessed by Zeus Scientific and two outside investigators. Samples collected from sexually active adults aged 17-70.
- HSV-1: Combined Sites: Sensitivity 98.4% (180/183), Specificity 92.5% (124/134).
- HSV-2: Combined Sites: Sensitivity 97.6% (80/82), Specificity 96.2% (226/235).
- Performance in a Population of Expectant Mothers: 150 archived, masked sera from a serum vendor (expectant mothers aged 18-48).
- HSV-1: Image indicates 98 positive, 0 indeterminate, 2 negative, site total 100. Sensitivity and Specificity provided through image description.
- HSV-2: Image indicates 59 positive, 0 indeterminate, 2 negative, site total 61. Sensitivity and Specificity provided through image description.
- Agreement with CDC Panel: Serum panel obtained from CDC, tested by Zeus Scientific.
- HSV-1: Positive agreement 100.0% (95% CI 94.2% to 100.0%), negative agreement 100.0% (95% CI 94.2% to 100.0%).
- HSV-2: Positive agreement 100.0% (95% CI 94.0% to 100.0%), negative agreement 98.1% (95% CI 89.7% to 100.0%).
- Performance in a Low Prevalence Population: Assessed internally using sera from a low prevalence serum bank (18 and 19 year old subjects previously tested for non-sexual infections). Compared to predicate device.
- HSV-1 Reactivity: Agreed with 100.0% (8/8) of immunoblot positives and 96.7% (56/58) of immunoblot negatives. Image shows sensitivity 100.0% (95% CI 63.1% to 100.0%) and specificity 96.7% (95% CI 88.1% to 99.6%).
- HSV-2 Reactivity: Agreed with 100% (0/0) of immunoblot positives and 100% (67/67) of immunoblot negatives. Image shows sensitivity 100.0% (95% CI 29.2% to 100.0%) and specificity 98.4% (95% CI 91.2% to 100.0%).
- Performance in a Population of Sexually Active Adults: 317 prospective samples assessed by Zeus Scientific and two outside investigators. Samples collected from sexually active adults aged 17-70.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sexually Active Adults HSV-1 (Combined Sites):
Sensitivity: 98.4% (180/183)
Specificity: 92.5% (124/134)
Sexually Active Adults HSV-2 (Combined Sites):
Sensitivity: 97.6% (80/82)
Specificity: 96.2% (226/235)
Agreement with CDC Panel HSV-1:
Positive agreement: 100.0% (95% CI 94.2% to 100.0%)
Negative agreement: 100.0% (95% CI 94.2% to 100.0%)
Agreement with CDC Panel HSV-2:
Positive agreement: 100.0% (95% CI 94.0% to 100.0%)
Negative agreement: 98.1% (95% CI 89.7% to 100.0%)
Performance in a Low Prevalence Population HSV-1:
Sensitivity: 100.0% (95% CI 63.1% to 100.0%)
Specificity: 96.7% (95% CI 88.1% to 99.6%)
Performance in a Low Prevalence Population HSV-2:
Sensitivity: 100.0% (95% CI 29.2% to 100.0%)
Specificity: 98.4% (95% CI 91.2% to 100.0%)
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
072178(k) Summary
AtheNA Multi-Lyte HSV 1 & 2 IgG Test System
510(k) 072178
Summary of Safety and Effectivenes
As required by 21 CFR 807.92, the following 510(k) summary is provided:
। Submitter Information
Contact:Ewa Nadolczak, Manager, Clinical Affairs Zeus Scientific, Inc. 200 Evans Way Branchburg, NJ 08876 Telephone: 908.243.4924 Direct: 347.731.0402 Email: enadolczak@zeusscientific.com Fax: 908.526.2058 Establishment Registration Number: 224236
2 Device Information
Proprietary Name: AtheNA Multi-Lyte HSV 1 & 2 IgG Test System Classification Name: Herpes Simplex Virus Serological reagents Class: Class II CFR: 866.3305
ਤੇ Predicate Device Information
Manufacturer: Focus Technologies Name: HerpeSelect 1 and 2 Immunoblot IgG Test System Methodology: Immunoblot 510 (k) Number: K000238
বী Device Description
The AtheNA Multi-Lyte HSV 1 & 2 IgG Test System is a microparticle immunoassay system intended for the qualitative detection of distict IgG antibody to HSV 1 and/or HSV 2. The test is a multiplexed immunoassay designed to simultaneously detect and distinguish IgG antibody to HSV 1 and/or 2 using recombinant HSV gG-1 and HSV gG-2 antigens. The test system is comprised of the AtheNA Multi-Lyte HSV 1 & 2 kit and the Luminex Corp instrument and software.
5 Intended Use
The Zeus Scientific, Inc. AtheNA Multi-Lyte HSV 1 & 2 Test System is intended for the qualitative detection of the absence or presence of IgG class antibody to HSV 1 and HSV 2 in human sera. The test is intended to be used as as an aid in the presumptive diagnosis of diseases caused by exposure to Herpes Simplex Virus 1 and 2 in sexually active adults and expectant mothers. The performance of this assay has not been established for use in a pediatric population, neonates and immunocompromised patients.
1
6 Summary of Technological Characteristics
The AtheNA Multi-Lyte HSV 1 & 2 IgG test system is a multiplexed, microparticle immunoassay designed to detect IgG class antibodies in human sera to HSV 1 and HSV 2 . The assay involves two incubation steps:
-
- Diluted test sera re incubated in a vessel containing a multiplexed mixture of bead suspension. The multiplexed bead suspension contains a mixture of distinguishable sets of polystyrene microspheres. Conjugated to the primary set of microspheres are the HSV 1 and 2 antigens. The bead mix also contains one bead set designed to detect nonspecific antibodies in the patient sample if present and four separate bead sets used for assay calibration. If present in patient sera, antibodies to the HSV 1 and/or HSV 2 antigen will bind to the immobilized antigen on the primary bead set. The microspheres are rinsed to remove non-reactive serum proteins.
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- Phycoerythrin-conjugated goat anti-human IgG (Fc specific) is added to the vessel and the plate is incubated. The conjugate will react with IgG antibody immobilized on the solid phase in step 1. The bead suspension is then analyzed by the AtheNA Multi-Lyte instrument. The bead sets are sorted, identified and the amount of reporter molecule (PE conjugate) is determined for each bead set. Using the Intra-well Calibration Technology, internal calibration bead sets are used to evaluate unknown specimens to determine their reactivity to Herpes Simplex virus.
7 Performance Data Non-Clinical
Establishment and Verification of Cut-off
The cut-off corresponds roughly to the mean plus (X) times the Standard Deviation of a negative population, X being the multiplication factor necessary to optimize the assay results. For HSV 1, 7 is the multiplication factor and for HSV 2, 6 is the multiplication factor used to establish the cut-off.
27 known negative samples, confirmed by a commercially distributed ELISA assay were tested to establish the cut-off. Additionally, a minimum of 5 known positive samples, also confirmed by a commercially distributed ELISA assay were tested. The results of the known positive samples were ascertained to exceed the theoretical cut-off as well as the negative samples were ascertained to fall below the theoretical cut-off.
Linearity
Two positive samples (one each for HSV1 and HSV 2) were tested neat and with two-fold serial dilutions using the AtheNA Multi-Lyte HSV 1 & 2 Test System. Results verify the linearity of the assay cut-off.
Limits of Detection
Three (each) strongly positive samples were serially diluted and tested using the AtheNA Multi-Lyte HSV 1 & 2 test system and a commercially available ELISA test system. Results demonstrate that the AtheNA Multi_lyte HSV 1 & 2 test system has comparable limits of detection to the commercially available ELISA test system.
Interfering Substances
Interfering Substances had been done based on industry standard levels of test concentrations recommended in CLSI EP7-A2. The quantity of analyte in each interfering substance is as follows:
2
Bilirubin: 1mg/dL (low), 15 mg/dL (high) Albumin: 3.5 g/dL (low), 5 g/dL (high) Cholesterol: 150 mg/dL (low), 250 mg/dL (high) Triglycerides: 150 mg/dL (low), 500 mg/dL (high) Hemoglobin: 20 g/dL (low), 20 g/dL (high} Intralipid: 300 mg/dL (low), 750 mg/dL (high) Three samples each for HSV-1 and HSV-2 were chosen based on their performance on the AtheNA Multi-Lyte test system: positive (HSV-1, 818 AU/mL; HSV-2, 566 AU/mL), borderline (HSV-1, 152 AU/ml; HSV-2, 92 AU/mL) and negative (HSV-1, 62 AU/mL; HSV-2, 34AU/mL). The samples were exposed to the possible interfering substance, tested in duplicate and the mean established. All samples showed less than a 20% change in signal with the exception of the negative HSV-1 sample which exhibited an increase in signal of 33% with the low spike of albumin and an increase in signal of 39% with the high spike of albumin. The negative HSV-2 sample showed a change in signal of 37% with the low spike of albumin and 28% with the high spike of albumin. The negative HSV-2 sample also showed changes in signal with bilirubin, 43% and 52%, albumin, 37% and 28%, hemoglobin, 53% and intralipids, 52% and 34%, low and high spikes of interfering substances respectively. The change of signal in these negative samples did not change the qualitative outcome in these samples, the results remained negative.
Cross-Reactivity
Studies were performed to assess cross reactivity with the Athena Multi-Lyte HSV 1 & 2 IgG test system using sera that were HSV dual-negative by immunoblot testing and that were sero-positive to Measles, Mumps, EBV VCA, EBNA, Rubella, VZV, ANA, CMV and Syphilis. ELISA and micro-particle immunoassay test systems manufactured by Zeus Scientific, Inc. for commercial distribution were used to determine the sero-positivity of the samples for each possible cross-reactant were tested. This study produced no detectable cross-reactivity with samples containing these various antibodies.
Additionally, monoclonal antibodies from potential cross reactants which may be confused clinically with HSV were tested.
| Possible Cross Reactant | Positive Results / Number Samples Tested |
|---|---|
| Measles | 0/10 |
| Mumps | 0/10 |
| EBV/VCA | 0/10 |
| EBNA | 0/10 |
| Rubella | 0/10 |
| VZV | 0/10 |
| ANA | 0/10 |
| CMV | 0/10 |
| Syphilis | 0/10 |
| Monoclonal Antibody | Qualitative Result | HSV 1 IgG | HSV 2 IgG |
|---|---|---|---|
| GONORRHEA 48075 | negative | 5 | 4 |
| MONOBILUNCUS 73502 | negative | 6 | 2 |
| BACTEROIDES 73049 | negative | 17 | 2 |
| VAGINALIS 73297 | negative | 4 | 4 |
| PAPILLOMA 170185 | negative | 3 | 4 |
| TRACHOMATIS 170120 | negative | 5 | 1 |
| GONORRHEA 197587 | negative | 0 | 0 |
| PAPILLOMA 184365 | negative | 2 | 5 |
| PAPILLOMA 326333 | negative | 5 | 3 |
Precision/Reproducibility
The study was conducted as outlined in Zeus Scientific, Inc. SOP-0180. Six samples were prepared based on their activity with the AtheNA Multi-Lyte HSV 1 & 2 IgG test system. Two samples selected were clearly negative, two were clearly positive and two were near the assay cut0off. This panel was split into six aliquots and tested at three sites. On each day of testing, each sample was diluted twice and each dilution run in quadruplicate, resulting in eight
3
results. This was performed for three days at each facility. A summary of this testing and calculations for the mean, standard deviation and CV appear in the following tables:
| Sample
ID | Index
Mean | Inter/ Intra-assay
Intra-assay
%CV | Inter/ Intra-assay
Inter-assay
%CV | Inter-Laboratory
Index
Mean | Inter-Laboratory
%CV of
Lab Means |
|--------------|---------------------------|------------------------------------------|------------------------------------------|-----------------------------------|-----------------------------------------|
| 1 | 26.3 | 15.0% | 18.2% | 26.3 | 21.8% |
| 2 | 8.4 | 39.2% | 44.0% | 8.4 | 58.2% |
| 3 | 144.8 | 11.9% | 15.9% | 144.8 | 16.6% |
| 4 | 195 | 11.0% | 12.3% | 195 | 15.9% |
| 5 | 311.8 | 8.4% | 9.9% | 311.8 | 10.7% |
| 6 | 392.2 | 8.5% | 9.1% | 392.2 | 12.8% |
| | Reproducibility HSV 2 IgG | | | | |
| | Inter/ Intra-assay | | Inter-Laboratory | | |
| Sample
ID | Index
Mean | Intra-assay
%CV | Inter-assay
%CV | Index
Mean | %CV of
Lab Means |
| 1 | 16.4 | 36.4% | 36.8% | 16.4 | 44.0% |
| 2 | 20.8 | 27.9% | 31.0% | 20.8 | 40.0% |
| 3 | 155.7 | 15.5% | 21.0% | 155.7 | 23.6% |
| 4 | 114.2 | 10.6% | 13.7% | 114.2 | 18.1% |
| 5 | 442.3 | 9.2% | 12.4% | 442.3 | 13.9% |
| 6 | 356.2 | 8.0% | 14.1% | 356.2 | 16.1% |
Performance Data Clinical
Expected Values
For the purpose of determining prevalence in the patient category "Prospectively Collected Samples from Sexually Active Adults", 317 patients whose sera were submitted for determining the absence or presence of HSV 1 & 2 IgG antibodies were tested at three clinical sites:
| Age | Sex | HSV 1 | Observed % Prevalence | HSV 2 | Observed % Prevalence | ||||
|---|---|---|---|---|---|---|---|---|---|
| Positive | Negative | total | HSV-1 | Positive | Negative | total | HSV-2 | ||
| 17-19 | Male | 4 | 1 | 2.1% | 5 | 0.0% | |||
| Female | 7 | 8 | 3.7% | 2 | 12 | 2.2% | |||
| 20-29 | Male | 20 | 22 | 10.6% | 6 | 36 | 6.7% | ||
| Female | 49 | 39 | 25.9% | 22 | 66 | 24.7% | |||
| Sex? | 2 | 4 | 1.1% | 2 | 4 | 2.2% | |||
| 30-39 | Male | 16 | 18 | 8.5% | 8 | 26 | 9.0% | ||
| Female | 31 | 7 | 16.4% | 12 | 27 | 13.5% | |||
| Sex? | 1 | 2 | 0.5% | 1 | 2 | 1.1% | |||
| 40-49 | Male | 14 | 6 | 7.4% | 6 | 14 | 6.7% | ||
| Female | 10 | 8 | 5.3% | 7 | 11 | 7.9% | |||
| 50-59 | Male | 19 | 5 | 10.1% | 12 | 12 | 13.5% | ||
| Female | 6 | 3 | 3.2% | 3 | 6 | 3.4% | |||
| Sex? | 1 | 0.5% | 1 | 1.1% | |||||
| 60-69 | Male | 5 | 2 | 2.6% | 4 | 3 | 4.5% | ||
| Female | 4 | 2 | 2.1% | 3 | 3 | 3.4% | |||
| Sub-total | Male | 78 | 54 | 41.3% | 36 | 96 | 40.4% | ||
| Female | 107 | 67 | 56.6% | 49 | 126 | 55.1% | |||
| Sex? | 4 | 6 | 2.1% | 4 | 6 | 4.5% | |||
| Total | 189 | 127 | 317 | 59.6% | 89 | 228 | 317 | 28.1% |
Note: HSV-1 total includes one equivocal result
4
For the purpose of determining prevalence in the patient category "Expectant Mothers", 150 retrospective samples were tested. Fifty samples were from mothers in the first trimester, 50 mothers were in the second trimester and 50 were in the third trimester of pregnancy:
| Age | Sex | HSV 1 | Observed % Prevalence | HSV 2 | Observed % Prevalence | ||||
|---|---|---|---|---|---|---|---|---|---|
| Positive | Negative | total | HSV-1 | Positive | Negative | total | HSV-2 | ||
| 17-19 | Female | 12 | 7 | 12.0% | 8 | 11 | 13.1% | ||
| 20-29 | Female | 52 | 27 | 52.0% | 37 | 42 | 60.7% | ||
| 30-39 | Female | 25 | 8 | 25.0% | 12 | 21 | 19.7% | ||
| 40-49 | Female | 11 | 8 | 11.0% | 4 | 15 | 6.6% | ||
| Total | 100 | 50 | 150 | 66.7% | 61 | 89 | 150 | 40.7% |
Agreement Summaries:
Performance in a Population of Sexually Active Adults
Zeus Scientific and two outside investigators assessed the device using a total of 317 prospective samples. The samples were sequentially submitted to the laboratories, archived and masked. The samples were collected from sexually active adults between the ages of 17 and 70 and submitted for Herpes simplex antibody testing.
5
Sexually Active Adults HSV-1
| Predicate Immunoblot | |||||||
|---|---|---|---|---|---|---|---|
| Positive | Indeterminate | Negative | Site Total | Sensitivity/ | |||
| Specificity | 95% CI | ||||||
| Site 1 | |||||||
| Positive | 82 | 1 | 4 | 87 | 96.5% 82/85 | 90.0% to 99.3% | |
| Equivocal | 0 | ||||||
| Negative | 3 | 45 | 48 | 91.8% 45/49 | 80.4% to 97.7% | ||
| Site Total | 85 | 1 | 49 | 135 | |||
| Site 2 | |||||||
| Positive | 49 | 2 | 51 | 100.0% 49/49 | 94.1% to 100.0% | ||
| Equivocal | 1 | 1 | |||||
| Negative | 32 | 32 | 91.4% 32/35 | 77.0% to 98.2% | |||
| Site Total | 49 | 0 | 35 | 84 | |||
| Site 3 | |||||||
| Positive | 49 | 2 | 51 | 100.0% 49/49 | 94.1% to 100.0% | ||
| Equivocal | 0 | ||||||
| Negative | 47 | 47 | 95.9% 47/49 | 86.0% to 99.5% | |||
| AtheNA Multi-Lyte | Site Total | 49 | 0 | 49 | 98 | ||
| Combined Sites | |||||||
| Positive | 180 | 1 | 8 | 189 | 98.4% 180/183 | 95.3% to 99.7% | |
| Equivocal | 1 | 1 | |||||
| Negative | 3 | 124 | 127 | 92.5% 124/134 | 86.7% to 96.3% | ||
| Combined Total | 183 | 1 | 133 | 317 |
.
:
6
| Sexually Active Adults HSV-2 | ||
|---|---|---|
| Predicate Immunoblot | |||||||
|---|---|---|---|---|---|---|---|
| Positive | Indeterminate | Negative | Site Total | Sensitivity/ | |||
| Specificity | 95% CI | ||||||
| Site 1 | |||||||
| Positive | 43 | 2 | 45 | 97.7% 43/44 | 88.0% to 99.9% | ||
| Equivocal | 0 | ||||||
| Negative | 1 | 1 | 88 | 90 | 97.8% 88/90 | 92.2% to 99.7% | |
| Site Total | 44 | 1 | 90 | 135 | |||
| Site 2 | |||||||
| Positive | 16 | 3 | 19 | 100% 16/16 | 82.9% to 100.0% | ||
| Equivocal | 0 | ||||||
| Negative | 65 | 65 | 95.6% 65/68 | 87.6% to 99.1% | |||
| Site Total | 16 | 0 | 68 | 84 | |||
| Site 3 | |||||||
| Positive | 21 | 4 | 25 | 100.0% 21/21 | 86.7% to 100.0% | ||
| Equivocal | 0 | ||||||
| Negative | 73 | 73 | 94.8% 73/77 | 87.2% to 98.6% | |||
| AtheNA Multi-Lyte | Site Total | 21 | 0 | 77 | 98 | ||
| Combined Sites | |||||||
| Positive | 80 | 9 | 89 | 97.6% 80/82 | 91.4% to 99.7% | ||
| Equivocal | 0 | ||||||
| Negative | 1 | 1 | 226 | 228 | 96.2% 226/235 | 92.9% to 98.2% | |
| Combined Total | 81 | 1 | 235 | 317 |
Performance in a Population of Expectant Mothers
Comparative studies were performed at Zeus Scientific using archived, masked sera obtained from a serum vendor. The 150 expectant mothers ranged in age from Of these 150 expectant mothers, 50 were in their first trimester of 18 to 48. pregnancy, 50 were in their second trimester and 50 were in their third trimester of pregnancy.
Image /page/6/Figure/4 description: The image shows two tables that display the results of Predicate Immunoblot tests for HSV-1 and HSV-2 in expectant mothers. For HSV-1, among those who tested positive, 98 were positive, 0 were indeterminate, and 2 were negative, with a site total of 100. For HSV-2, among those who tested positive, 59 were positive, 0 were indeterminate, and 2 were negative, with a site total of 61. The sensitivity and specificity are also provided for each test, along with the confidence intervals.
7
Agreement with CDC Panel
The following information is from a serum panel obtained from the CDC and tested by Zeus Scientific, Inc. The results are presented to convey further information on the performance of the AtheNA Multi-Lyte HSV 1 & 2 IgG assay with a masked, characterized serum panel. This does not imply endorsement of the assay by the CDC .
Image /page/7/Figure/2 description: The image shows two tables, one for HSV-1 and one for HSV-2, displaying the results of a CDC panel. For HSV-1, the positive agreement is 100.0% with a 95% CI of 94.2% to 100.0%, and the negative agreement is also 100.0% with the same CI. For HSV-2, the positive agreement is 100.0% with a 95% CI of 94.0% to 100.0%, while the negative agreement is 98.1% with a 95% CI of 89.7% to 100.0%.
Performance in a Low Prevalence Population
The relative specificity of the AtheNA Multi-Lyte HSV 1 & 2 test system was assessed internally using sera from a low prevalence population. The low prevalence population was comprised of sera stored in a serum bank at the manufacturer site. Archived, masked serum samples from 18 and 19 year old subjects previously tested for infections considered non-sexual in nature was tested and performance compared to the predicate device.
HSV-1 Reactivity: The predicate immunoblot device was positive for 7 samples and neqative for 60 samples. The AtheNA Multi-Lyte HSV 1& 2 IgG test system agreed with 100.0% (8/8) of immunoblot positives and 96.7% (56/58) of immunoblot negatives.
HSV-2 Reactivity: The predicate immunoblot device was positive for 0 samples and neqative for 67 samples. The AtheNA Multi-Lyte HSV 1& 2 IgG test system agreed with 100% (0/0) of immunoblot positives and 100% (67/67) of immunoblot negatives.
Image /page/7/Figure/7 description: The image shows two tables displaying the results of Predicate Immunoblot tests for HSV-1 and HSV-2 in a low prevalence population. For HSV-1, the table shows the counts for positive, indeterminate, and negative results, with a sensitivity of 100.0% (95% CI 63.1% to 100.0%) and a specificity of 96.7% (95% CI 88.1% to 99.6%). Similarly, for HSV-2, the table presents the counts for each result category, along with a sensitivity of 100.0% (95% CI 29.2% to 100.0%) and a specificity of 98.4% (95% CI 91.2% to 100.0%). Both tables include site totals and confidence intervals calculated using the EXACT method.
NOTE :
The test is for in vitro use only.
The performance of this assay has not been established for neonatal, pediatric, immunocompromised populations, cord blood or pre-transplant patients. The use of whole blood or plasma is not established.
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Image /page/8/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be an abstract caduceus, a symbol often associated with healthcare. The caduceus is depicted with three intertwined strands and a single wing-like element.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 3 0 2008
Ms. Ewa Nadolczak Manager, Clinical Affairs Zeus Scientific, Inc. 200 Evans Way Branchburg, NJ 08876
Re: K072178
Trade/Device Name: AtheNA Multi-Lyte® HSV 1 & 2 IgG Test System Regulation Number: 21 CFR 866,3305 Regulation Name: Herpes Simplex Virus Serolical Reagents Regulatory Class: Class II Product Code: MXJ, MYF Dated: May 23, 2008 Received: May 28, 2008
Dear Ms. Nadolczak:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally attaym
Sally A. 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
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Indications for Use
510(k) Number (if known): (k) 072178
Device Name: AtheNA Multi-Lyte® HSV 1 & 2 IgG Test System
Indications For Use:
The Zeus Scientific, Inc. AtheNA Multi-Lyte® HSV 1 & 2 IgG Test System is intended for the qualitative detection of the presence or absence of human IqG class antibodies to Herpes Simplex virus I and 2 in human sera. The test is indicated for sexually active adults and expectant mothers, as an aid for presumptively diagnosing Herpes Simplex 1 and 2. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-1 and HSV-2. The test is not intended for donor screening or for self testing.
The performance of this assay has not been established for use in a pediatric population, neonates, immunocompromised patients, for use by point of care facilities or for use with automated equipment.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Uve Schaf
Division Sign Off
Division Sign-Off
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Office of In Vitro Diagnostic Device Evaluation and Safety
6072178 510(k).