(153 days)
Unknown
Not Found
No
The document describes a standard ELISA test for detecting antibodies and does not mention any AI or ML components in its description, intended use, or performance studies.
No.
The device is an in vitro diagnostic test for detecting antibodies to VZV, which aids in diagnosis rather than providing therapy.
Yes
The "Intended Use / Indications for Use" states that the system is "intended for the qualitative detection of IgM class antibodies to Varicella Zoster Virus in human serum as an aid in the diagnosis of primary infection or reactivation." The phrase "aid in the diagnosis" clearly indicates its diagnostic purpose.
No
The device is an ELISA test system, which is a laboratory assay involving physical reagents and processes, not solely 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 IgM class antibodies to Varicella Zoster Virus in human serum as an aid in the diagnosis of primary infection or reactivation." This clearly indicates it's used to test a sample taken from the human body (serum) to provide information for diagnostic purposes.
- Device Description: The description confirms it's an "enzyme linked immunosorbent assay" designed to detect antibodies in a sample. This is a common method used in IVD tests.
- Sample Type: The test uses "human serum," which is a biological sample taken from a human.
- Performance Studies: The document details various performance studies (Clinical Agreement Summary, Precision, Cross-Reactivity, etc.) which are typical for demonstrating the analytical and clinical performance of an IVD device.
- Comparison to Predicate Device: The mention of a "Predicate Device" (Captia VZV IgM ELISA Test Kit) indicates that this device is being compared to an existing, legally marketed IVD device.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Zeus Scientific Varicella-Zoster (VZV) IgM ELISA Test System is intended for the qualitative detection of IgM antibody to Varicella-Zoster virus in human serum as an aid in diagnosis of primary infection or reactivation.
The assay performance in detecting antibodies to VZV in individuals Vaccinated with the FDA licensed VZV vaccine is unknown. The user of this Assay is responsible for establishing the performance characteristics with VZV vaccinated individuals. The assay performance in detecting antibodies to VZV antibodies to VZV in cord blood and neonates has not been established.
The Zeus Scientific Varicella Zoster Virus (VZV) IgM ELISA Test System is intended for the qualitative detection of IgM class antibodies to Varicella Zoster Virus in human serum as an aid in the diagnosis of primary infection or reactivation.
The assay performance in detecting antibodies to VZV in individuals vaccinated with the FDA licensed VZV vaccine is unknown.
The user of this assay is responsible for establishing the performance characteristics with VZV vaccinated individuals.
The assay performance in detecting antibodies to VZV in cord blood and neonates has not been established.
Product codes
LFY
Device Description
The Zeus Scientific VZV IgM ELISA Test System is an enzyme linked immunosorbent assay intended for the qualitative detection of distict IgM antibody to the Varicella-zoster virus.
The test is designed to detect IgM antibody using inactivated VZV antigen: strain, Ellen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
25 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.
Data was obtained from 302 prospective samples. Two samples were submitted with no sex designated. The presence of VZV IgM antibody in 302 prospective samples and 36 retrospective samples was evaluated at three sites using the Zeus Scientific VZV IgM ELISA Test System and a commercially distributed VZV IgM ELISA test system.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Establishment and Verification of Cut-off
25 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
Four positive samples were tested neat and with two-fold serial dilutions using the Zeus Scientific VZV IgM ELISA Test System. Results verify the linearity of the assay cut-off.
Limits of Detection
Four strongly positive samples were serially diluted and tested using the Zeus Scientific VZV IgM Test System and a commercially available EUISA test system. Results demonstrate that the Zeus Scientific VZV IgM ELISA 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. As depicted in the table above, the positive samples showed a range of recovery from 110.66% with the high spike of hemoglobin to a low of 48.6% with the high spike of IgG. The negative sample showed a range of recovery from 400% with the high spike of IgG to a low of 88.24% with the low spike of albumin. The borderline sample showed a range of recovery of 109.64% with the high spike of hemoglobin to a low of 83% with the low spike of IgG. Some elevation of signal in the presence of excess hemoglobin was noted. The anti-IgG absorbent (SaVE Diluent) has been found to functionally remove > 13.9 mg/mL IgG from human serum. Patients with an IgG level exceeding 14 mg/mL may require additional treatment to neutralize all IgG. Excessively high levels of IgG have been shown to reduce reactivity to VZV IgM antibody.
Cross-Reactivity
A minimum of 10 samples, negative for VZV IgM, were acquired and the reactivity confirmed using the predicate device. The 10 samples were subsequently tested for cross-reactivity. In all cases the specimens remained negative for VZV IgM. All results are presented as Index Values except where noted.
IgM Destruction
A VZV IgM destruction experiment was performed to assure that the antibody which is detected by the Zeus Scientific VZV IgM ELISA Test System is indeed IgM antibody. 2% beta-mercaptoethanol was the IgM destroying agent used in this study.
The results of the VVV IgM destruction study clearly demonstrate that the IgM antibody was destroyed, capturing the information that the antibody detected by the Zeus Scientific VZV IgM ELISA Test System is indeed VZV IgM antibody.
IgG/RF Removal
The Zeus Scientific VZV IgM ELISA Test System provides sample diluent which binds IgG and RF antibodies which may potentially cross-react with IgM antibodies during assay procedure. An IgG/RF removal experiment was performed. Results presented below demonstrate that the Sample Diluent eliminates reactivity of IgG and RF.
Precision
Six samples were prepared based on their activity with the Zeus Scientific VZV IgM ELISA 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 results. This was performed for three days at each facility.
Clinical Performance: Agreement Summary
The presence of VZV IgM antibody in 302 prospective samples and 36 retrospective samples was evaluated at three sites using the Zeus Scientific VZV IgM ELISA Test System and a commercially distributed VZV IgM ELISA test system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Prospective Samples: Combined Sites
Positive % Agreement = 6/6 = 100% 95% Confidence Interval**= 54.1% to 100.0%
Negative % Agreement = 281/294 = 95.6% 95% Confidence Interval**= 92.6% to 97.6%
Prospective and Retrospective Samples: Combined Sites
Positive % Agreement = 38/39 = 97.4% 95% Confidence Interval**= 86.5% to 99.9%
Negative % Agreement = 282/297 = 95.6% 95% Confidence Interval**= 91.8% to 97.1%
Predicate Device(s)
Unknown
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3900 Varicella-zoster virus serological reagents.
(a)
Identification. Varicella-zoster virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to varicella-zoster in serum. The identification aids in the diagnosis of diseases caused by varicella-zoster viruses and provides epidemiological information on these diseases. Varicella (chicken pox) is a mild, highly infectious disease, chiefly of children. Zoster (shingles) is the recurrent form of the disease, occurring in adults who were previously infected with varicella-zoster viruses. Zoster is the response (characterized by a rash) of the partially immune host to a reactivation of varicella viruses present in latent form in the patient's body.(b)
Classification. Class II (performance standards).
0
510 (k) Summary
JUL - 5 2007 Zeus Scientific VZV IgM ELISA Test System
510 (k) 070317
As required by 21 CFR 807.92, the following 510(k) summary is provided:
Submitter Information ਜ
Contact:Ewa Nadolczak, Manager, Clinical Affairs Zeus Scientific, Inc. 200 Evans Way Branchburg, NJ 08876 Telephone: 908.526.3744 Direct: 347.731.0402 Email: enadolczak@zeusscientific.com Fax: 908.526.2058 Establishment Registration Number: 224236
Device Information 2
Proprietary Name: Zeus Scientific Varicella-Zoster (VZV) IgM ELISA Test Kit Classification Name: Varicella-zoster Virus Serological reagents Class: Class II CFR: 866.39 Product Code: LFY
Predicate Device Information 3
Manufacturer: Trinity Biotech Name: Captia VZV IgM ELISA Test Kit Methodology: ELISA 510{k} Number: Unknown
Device Description বা
The Zeus Scientific VZV IgM ELISA Test System is an enzyme linked immunosorbent assay intended for the qualitative detection of distict IgM antibody to the Varicella-zoster virus.
The test is designed to detect IgM antibody using inactivated VZV antigen: strain, Ellen.
5 Intended Use
The Zeus Scientific VZV IgM ELISA Test System is intended for the qualitative detection of IgM antibody to Varicella-Zoster virus in human serum as an aid in diagnosis of primary infection or reactivation.
The assay performance in detecting antibodies to VZV in individuals Vaccinated with the FDA licensed VZV vaccine is unknown. The user of this Assay is responsible for establishing the performance characteristics with VZV vaccinated individuals. The assay performance in detecting antibodies to VZV antibodies to VZV in cord blood and neonates has not been established.
1
6 Summary of Technological Characteristics
The Zeus Scientific VZV IgM ELISA Test System is designed to detect IgM class antibodies in human sera to Varicella-zoster virus. Wells of plastic microwell strips are sensitized by passive absorption with VZV antigen. The test procedure involves three incubation steps:
Test sera are diluted with the Sample Diluent provided. The Sample Diluent contains anti-human IgG that is intended to bind IgG and Rheumatoid factor to prevent non-specific binding to the immobilized antigen. During sample incubation, any antigen specific IgM antibody in the sample will bind to the immobilized antigen. The plate is washed to remove unbound antibody and other serum components.
Peroxidase conjugated goat anti-human (u chain specific) is added to the wells and the plate is incubated. The conjugate will react with IgM antibody immobilized in the solid phase I, step 1.
The microwells containing immobilized peroxidase conjugate are incubated with peroxidase substrate solution. Hydrolysis of the substrate by peroxidase produces a color change. After a period of time, the reaction is stopped and the color intensity of the solution is measured photometrically. The color intensity of the solution depends upon the antibody concentration in the original test sample.
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.
25 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
Four positive samples were tested neat and with two-fold serial dilutions using the Zeus Scientific VZV IgM ELISA Test System. Results verify the linearity of the assay cut-off.
Limits of Detection
Four strongly positive samples were serially diluted and tested using the Zeus Scientific VZV IgM Test System and a commercially available EUISA test system. Results demonstrate that the Zeus Scientific VZV IgM ELISA 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
2
test concentrations recommended in CLSI EP7-A2. The data is presented on the following page:
Interfering Substance Study
| Spiked | SAMPLE 2 | SAMPLE 3 | |||||
|---|---|---|---|---|---|---|---|
| Level | VZV IgM | % Positive | VZV IgM | % Positive | VZV IgM | % Control | |
| Positive | Signal | Borderline | Signal | Negative | Signal | ||
| Control-PBS | N/A | 3.67 | 0.88 | 0.07 | |||
| ontrol-Ethanol | N/A | 3.59 | 0.82 | 0.07 | |||
| Bilirubin | Low | 3.78 | 103.16% | 0.93 | 105.33% | 0.08 | 123.53% |
| Bilirubin | High | 3.59 | 97.93% | 0.90 | 101.7% | 0.06 | 92.65% |
| Albumin | Low | 3.63 | 99.05% | 0.91 | 103.63% | 0.06 | 88.24% |
| Albumin | High | 3.82 | 104.01% | 0.89 | 100.45% | 0.07 | 108.82% |
| lgG | Low | 2.71 | 69.6% | 0.79 | 83.0% | 0.10 | 245.0% |
| lgG | High | 1.98 | 48.6% | 0.51 | 56.70% | 0.16 | 400.0% |
| Cholesterol | Low | 3.50 | 97.63% | 0.88 | 107.6% | 0.07 | 100.0% |
| Cholesterol | High | 3.60 | 100.33% | 0.88 | 107.6% | 0.07 | 102.82% |
| Triglycerides | Low | 3.80 | 105.94% | 0.87 | 106.99% | 0.07 | 100.0% |
| Triglycerides | High | 3.79 | 105.61% | 0.88 | 107.6% | 0.07 | 92.96% |
| Hemoglobin | Low | 3.77 | 102.81% | 0.94 | 106.58% | 0.14 | 201.47% |
| Hemoglobin | High | 4.06 | 110.66% | 0.97 | 109.64% | 0.11 | 167.65% |
| Intralipid | Low | 3.77 | 102.73% | 0.87 | 98.53% | 0.08 | 120.59% |
| Intralipid | High | 3.62 | 98.66% | 0.87 | 98.75% | 0.07 | 98.53% |
| Control | N/A | 3.66 | 0.89 | 0.06 |
Zeus Scientific VZV IgM ELISA
As depicted in the table above, the positive samples showed a range of recovery from 110.66% with the high spike of hemoglobin to a low of 48.6% with the high spike of IgG. The negative sample showed a range of recovery from 400% with the high spike of IgG to a low of 88.24% with the low spike of albumin. The borderline sample showed a range of recovery of 109.64% with the high spike of hemoglobin to a low of 83% with the low spike of IgG.
Some elevation of signal in the presence of excess hemoglobin was noted. The anti-IgG absorbent (SaVE Diluent) has been found to functionally remove > 13.9 mg/mL IgG from human serum. Patients with an IgG level exceeding 14 mg/mL may require additional treatment to neutralize all IgG. Excessively high levels of IgG have been shown to reduce reactivity to VZV IgM antibody.
Cross-Reactivity
A minimum of 10 samples, negative for VZV IgM, were acquired and the reactivity confirmed using the predicate device. The 10 samples were subsequently tested for cross-reactivity. In all cases the specimens remained negative for VZV IgM. Please refer to the data below. All results are presented as Index Values except where noted.
3
| Sample
ID | EBV VCA IgM
ELISA Result | Zeus Scientific
VZV IgM
ELISA Result | Sample ID | CMV IgM
ELISA Result | Zeus Scientific
VZV IgM
ELISA Result |
|--------------|-----------------------------|--------------------------------------------|-----------|-------------------------|--------------------------------------------|
| EBV M 5 | 3.54 | 0.77 | CMV M 33 | 5.22 | 0.66 |
| EBV M 13 | 4.95 | 0.50 | CMV M 34 | 4.42 | 0.53 |
| EBV M 15 | 1.94 | 0.40 | CMV M 35 | 1.63 | 0.64 |
| EBV M 16 | 3.42 | 0.33 | CMV M 36 | 1.45 | 0.21 |
| EBV M 17 | 5.23 | 0.52 | CMV M 37 | 1.57 | 0.26 |
| EBV M 19 | 2.24 | 0.18 | CMV M 41 | 2.65 | 0.42 |
| EBV M 20 | 1.19 | 0.10 | RD3901 | 6.92 | 0.89 |
| 431062 | 6.03 | 0.76 | 00177 | 9.00 | 0.13 |
| 430410 | 3.50 | 0.32 | 429023.00 | 6.34 | 0.86 |
| 430411 | 3.80 | 0.83 | 429057.00 | 3.33 | 0.78 |
| Zeus Scientific | ||
|---|---|---|
| Sample | Lyme IgM | VZV IgM |
| ID | ELISA Result | ELISA Result |
| Lyme M 2 | 4.41 | 0.43 |
| Lyme M 7 | 3.76 | 0.40 |
| Lyme M 13 | 5.27 | 0.56 |
| Lyme M 16 | 1.16 | 0.21 |
| Lyme M 17 | 3.43 | 0.37 |
| Lyme M 18 | 1.59 | 0.21 |
| Lyme M 20 | 3.27 | 0.32 |
| Lyme M 23 | 4.35 | 0.64 |
| 430068.00 | 2.26 | 0.64 |
| 436804.00 | 3.51 | 0.61 |
and the comments of the comments of the comments of
| IU/mL | Zeus Scientific | |
|---|---|---|
| Sample | RF IgM | VZV IgM |
| ID | ELISA Result | ELISA Result |
| RF M 2 | 24.2 | 0.08 |
| ARF 1 | 16.7 | 0.06 |
| ARF 2 | 93.9 | 0.72 |
| ARF 3 | 65.5 | 0.53 |
| ARF 4 | 45.4 | 0.40 |
| ARF 5 | 19.5 | 0.06 |
| ARF 6 | 71.4 | 0.17 |
| 430066 | 85.8 | 0.66 |
| 430067 | 93.9 | 0.39 |
| 436932 | 25.6 | 0.21 |
| Sample
ID | Mumps IgM
ELISA Result | Zeus Scientific
VZV IgM
ELISA Result |
|--------------|---------------------------|--------------------------------------------|
| Mumps1 | 5.40 | 0.17 |
| Mumps2 | 5.30 | 0.14 |
| Mumps3 | 4.80 | 0.16 |
| Mumps4 | 4.40 | 0.13 |
| Mumps5 | 2.18 | 0.09 |
| Mumps6 | 1.48 | 0.08 |
| Mumps7 | 4.88 | 0.11 |
| Mumps8 | 4.17 | 0.13 |
| Mumps9 | 3.65 | 0.11 |
| Mumps10 | 2.81 | 0.10 |
:
:
4
| Sample
ID | Toxo IgM
ELISA Result | Zeus Scientific
VZV IgM
ELISA Result |
|--------------|--------------------------|--------------------------------------------|
| Toxo M 38 | 1.42 | 0.36 |
| Toxo M 45 | 2.95 | 0.15 |
| Toxo M 46 | 3.34 | 0.71 |
| Toxo M 47 | 3.18 | 0.41 |
| SX36034 | 1.86 | 0.23 |
| RD4024 | 1.64 | 0.79 |
| 430472 | 1.95 | 0.18 |
| 434830 | 1.99 | 0.25 |
| 434831 | 2.06 | 0.21 |
| 434832 | 2.11 | 0.26 |
| Sample
ID | Measles IgM
ELISA Result | Zeus Scientific
VZV IgM
ELISA Result |
|--------------|-----------------------------|--------------------------------------------|
| Measles1 | 2.49 | 0.31 |
| Measles2 | 1.61 | 0.26 |
| Measles3 | 1.53 | 0.23 |
| Measles4 | 1.82 | 0.26 |
| Measles5 | 1.32 | 0.24 |
| Measles6 | 2.21 | 0.30 |
| Measles7 | 1.64 | 0.24 |
| Measles8 | 1.25 | 0.20 |
| Measles9 | 2.14 | 0.30 |
| Measles10 | 2.68 | 0.30 |
| Sample
ID | Rubella IgM
ELISA Result | Zeus Scientific
VZV IgM
ELISA Result |
|--------------|-----------------------------|--------------------------------------------|
| RM 18 | 1.15 | 0.20 |
| RM 19 | 1.51 | 0.33 |
| RM 20 | 1.96 | 0.28 |
| RM 35 | 1.93 | 0.19 |
| RM 36 | 1.47 | 0.04 |
| RM 37 | 2.55 | 0.08 |
| RD3847 | 2.29 | 0.63 |
| RD4814 | 2.91 | 0.18 |
| 437706 | 2.09 | 0.18 |
| RD6766 | 2.24 | 0.10 |
| Result Key: |
|---|
| Positive |
| Equivocal |
| Negative |
IgM Destruction
A VZV IgM destruction experiment was performed to assure that the antibody which is detected by the Zeus Scientific VZV IgM ELISA Test System is indeed IgM antibody. 2% beta-mercaptoethanol was the IgM destroying agent used in this study .
The results of the VVV IgM destruction study clearly demonstrate that the IgM antibody was destroyed, capturing the information that the antibody detected by the Zeus Scientific VZV IgM ELISA Test System is indeed VZV IgM antibody.
IgG/RF Removal
The Zeus Scientific VZV IgM ELISA Test System provides sample diluent which binds IgG and RF antibodies which may potentially cross-react with IgM antibodies during assay procedure. An IgG/RF removal experiment was performed. Results presented below demonstrate that the Sample Diluent eliminates reactivity of IgG and RF.
5
| IgG Sample Diluent | IgM Sample Diluent | |||||||
|---|---|---|---|---|---|---|---|---|
| IgG Conj | IgG Sample Diluent | IgG Conj | IgM Sample Diluent | |||||
| Sample ID | OD | ISR | OD | ISR | OD | ISR | OD | ISR |
| VZG+7 | 2.902 | 8.221 | 0.189 | 0.536 | 0.002 | 0.006 | 0.11 | 0.311 |
| VZG+ 19 | >3.0 | 8.497 | 0.23 | 0.651 | 0.0 | 0.0 | 0.068 | 0.192 |
| RF+ 5 | 0.13 | 0.369 | 0.016 | 0.045 | 0.006 | 0.016 | 0.017 | 0.047 |
| VZM+ RD5161 | 2.914 | 8.254 | 0.776 | 2.197 | 0.0 | 0.001 | 0.728 | 2.063 |
| VZM- 426642 | >3.0 | 8.497 | 0.076 | 0.214 | 0.0 | 0.0 | 0.023 | 0.006 |
| VZM- 418523 | 1.335 | 3.78 | 0.172 | 0.487 | 0.001 | 0.003 | 0.099 | 0.282 |
| VZG7/RF5 | 2.325 | 6.586 | 0.255 | 0.721 | 0.0 | 0.0 | 0.08 | 0.227 |
| VZG19/RF5 | 2.768 | 7.84 | 0.213 | 0.604 | 0.0 | 0.0 | 0.044 | 0.124 |
Precision
Six samples were prepared based on their activity with the Zeus Scientific VZV IgM ELISA 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 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:
| Site 1 | Site 2 | Site 3 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1 | Day 2 | Day 3 | Day 1 | Day 2 | Day 3 | Day 1 | Day 2 | Day 3 | ||||
| Sample 1 | ||||||||||||
| mean | 3.38 | 3.52 | 3.50 | 3.60 | 4.21 | 3.69 | 3.43 | 3.54 | 3.38 | |||
| sd | 0.10 | 0.06 | 0.08 | 0.03 | 0.12 | 0.06 | 0.08 | 0.10 | 0.07 | |||
| %CV | 2.8% | 1.8% | 2.2% | 1.0% | 2.9% | 1.5% | 2.3% | 2.7% | 2.1% | |||
| Sample 2 | ||||||||||||
| mean | 2.89 | 2.90 | 2.86 | 2.96 | 3.18 | 2.92 | 2.99 | 2.97 | 2.95 | |||
| sd | 0.03 | 0.02 | 0.09 | 0.05 | 0.04 | 0.06 | 0.03 | 0.08 | 0.07 | |||
| %CV | 1.0% | 0.8% | 3.0% | 1.6% | 1.4% | 2.1% | 1.1% | 2.7% | 2.3% | |||
| Sample 3 | ||||||||||||
| mean | 0.26 | 0.23 | 0.24 | 0.34 | 0.40 | 0.33 | 0.19 | 0.20 | 0.18 | |||
| sd | 0.01 | 0.01 | 0.01 | 0.01 | 0.01 | 0.01 | 0.01 | 0.01 | 0.01 | |||
| %CV | 5.0% | 2.3% | 3.4% | 2.1% | 2.9% | 3.8% | 3.8% | 7.5% | 8.0% | |||
| Sample 4 | ||||||||||||
| mean | 0.13 | 0.11 | 0.10 | 0.15 | 0.14 | 0.13 | 0.12 | 0.13 | 0.10 | |||
| sd | 0.00 | 0.00 | 0.00 | 0.01 | 0.01 | 0.01 | 0.01 | 0.01 | 0.01 | |||
| %CV | 3.6% | 3.6% | 2.6% | 5.0% | 4.0% | 7.1% | 7.5% | 7.3% | 8.5% | |||
| Sample 5 | ||||||||||||
| mean | 0.91 | 0.89 | 0.94 | 0.82 | 0.89 | 0.91 | 0.95 | 0.91 | 0.93 | |||
| sd | 0.01 | 0.02 | 0.02 | 0.02 | 0.01 | 0.02 | 0.02 | 0.03 | 0.02 | |||
| %CV | 1.5% | 2.5% | 2.4% | 2.8% | 1.5% | 1.8% | 2.6% | 2.8% | 1.7% | |||
| Sample 6 | ||||||||||||
| mean | 0.90 | 0.89 | 0.88 | 0.73 | 0.87 | 0.91 | 1.00 | 0.93 | 0.91 | |||
| sd | 0.02 | 0.02 | 0.01 | 0.02 | 0.02 | 0.01 | 0.03 | 0.02 | 0.03 | |||
| %CV | 3.0% | 2.0% | 0.9% | 3.3% | 2.4% | 1.4% | 3.3% | 2.5% | 3.4% |
6
| Inter-Assay Precison Summary | Between Site Summary | ||||||
|---|---|---|---|---|---|---|---|
| Site 1 | Site 2 | Site 3 | |||||
| Sample 1 | mean | 3.84 | 3.45 | Sample 1 | mean | 3.6 | |
| sd | 0.10 | 0.29 | 0.10 | sd | 0.3 | ||
| %CV | 0.03 | 0.07 | 0.03 | %CV | 7.1% | ||
| Sample 2 | mean | 2.90 | 3.02 | 2.97 | Sample 2 | mean | 3.0 |
| sd | 0.10 | 0.13 | 0.06 | sd | 0.1 | ||
| %CV | 0.02 | 0.04 | 0.02 | %CV | 3.4% | ||
| Sample 3 | mean | 0.20 | 0.36 | 0.19 | Sample 3 | mean | 0.3 |
| sd | 0.00 | 0.03 | 0.01 | sd | 0.1 | ||
| %CV | 0.07 | 0.10 | 0.07 | %CV | 28.1% | ||
| Sample 4 | mean | 0.10 | 0.14 | 0.11 | Sample 4 | mean | 0.1 |
| sd | 0.00 | 0.01 | 0.01 | sd | 0.0 | ||
| %CV | 0.11 | 0.07 | 0.13 | %CV | 14.1% | ||
| Sample 5 | mean | 0.90 | 0.87 | 0.93 | Sample 5 | mean | 0.9 |
| sd | 0.00 | 0.05 | 0.03 | sd | 0.0 | ||
| %CV | 0.03 | 0.05 | 0.03 | %CV | 4.6% | ||
| Sample 6 | mean | 0.90 | 0.84 | 0.95 | Sample 6 | mean | 0.9 |
| sd | 0.00 | 0.08 | 0.05 | sd | 0.1 | ||
| %CV | 0.02 | 0.10 | 0.05 | %CV | 8.0% |
Performance Data
Clinical
Expected Values
Data was obtained from 302 prospective samples. Two samples were submitted with no sex designated. The data is visualized in the table below:
7
| April 2017 Spainen Grup Con VZV (gMPasilie 2017 VZV IgMegatie 2017 (gMEquical 2010) (gMExicolor 2010) (gMExicolor 2010) (gMB) 2010) (gMBC 2010) (gMB) 2010) (gMB) 2010) (gMB) | |||||
|---|---|---|---|---|---|
| 1-9 | Prospective Males | 1 | 4 | ||
| Prospective Fernales | 3 | ||||
| ール、日本の中古、「アドリア」、「アイマン、アドレスト」(アイデン・ミード)」「アイバー | |||||
| 10-19 | Prospective Males | 1 | 10 | ||
| Prospective Fernales | 19 | 1 | |||
| :"中国" | 【行】【下】【下】【,】【有】【的】【不】【,】【不】【,】【 | ||||
| 20-29 | Prospective Males | 13 | |||
| Prospective Ferrales | ങ്കട | 2 | |||
| Sex Unknown | 1 | 1 11 11 1939 14 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 | |||
| 1984년 1월 1일 19일 10월 1일 11월 11일 11일 11일 10일 10월 10일 10월 10일 10월 10일 10월 10일 10월 10일 10일 10일 10일 10일 10일 10일 10일 10일 10일 10일 10일 10일 10일 10일 10일 10일 10일 10일 10일 10일 10일 10일 1 | |||||
| 30-30 | Prospective Males | 14 | |||
| Prospective Ferrales | હિન્ત | ||||
| Sex Unknown | 1 | ||||
| 40-40 | Prospective Males | 7 | |||
| Prospective Ferrales | 26 | ||||
| . | |||||
| સ્ત્રન્સ્સ | Prospective Males | 7 | |||
| Propodite Fernales 19 Marceller Formalia 2017 Manufactures 2017 Marchiterial Comments 2017 Marine 2017 Press | |||||
| റ്റാക്കു | Prospective Males | 4 | |||
| Prospective Ferrales | വ | 10 | |||
| ் பிரிக்கு இருக்கும் இருக்கும் இந்து முறைய வருகின்றன. இந்த திரைப்படுகின்றன. முறைய முறைய மாறு முறையில் பய | |||||
| 70+ | Prospective Males | ਤੇ | |||
| য | Prospective Familes Prospective Forman | ານ ການປະກວດນ້າງງາມ ແລະ | |||
| Total: | Prospective Males | 2 | 62 | ||
| Prospective Ferrales | प | 227 | 5 | ||
| Sex Unknown | വ | 이 대한민국 대학교 대학교 대학교 대학교 대학교 대학교 대학교 대학교 대학교 대학 | |||
| Total: | ి | 291 | 5 | ||
| tota | 300 |
Agreement Summary
The presence of VZV IgM antibody in 302 prospective samples and 36 retrospective samples was evaluated at three sites using the Zeus Scientific VZV IgM ELISA Test System and a commercially distributed VZV IgM ELISA test system.
.
8
Prospective Samples:Combined Sites
Commercial ELISA Results
| + | - | +/- | Totals | |
|---|---|---|---|---|
| + | 6 | 4 | 2 | 12 |
| - | 281 | 281 | ||
| +/- | 7 | 2 | 9 | |
| Totals | 6 | 292 | 4 | 302 |
Positive % Agreement = 6/6 = 100% 95% Confidence Interval**= 54.1% to 100.0% Negative % Agreement = 281/294 = 95.6% 95% Confidence Interval**= 92.6% to 97.6%
us Scientific,
eus Scientific, I
Prospective and Retrospective Samples:Combined Sites
Commercial ELISA Results
| + | - | +/- | Totals | |
|---|---|---|---|---|
| + | 38 | 4 | 4 | 46 |
| - | 282 | 282 | ||
| +/- | 1 | 7 | 2 | 10 |
| Totals | 39 | 293 | 6 | 338 |
Positive % Agreement = 38/39 = 97.4% 95% Confidence Interval**= 86.5% to 99.9% Negative % Agreement = 282/297 = 95.6% 95% Confidence Interval**= 91.8% to 97.1%
The test is for in vitro use only. The performance of this assay has not been established for neonatal, immunocomprimised populations, cord blood or pre-transplant patients. The use of whole blood or plasma is not established.
9
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its back, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper half of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL - 5 2007
Ewa K. Nadolczak Manager Clinical Affairs ZEUS Scientific, Inc. P.O. Box 38 Raritan, New Jersey 08869
Re: K070317
Trade/Device Name: Zeus Scientific, VZV IgM ELISA Test System
Regulation Number: 21 CFR 866.3900 Regulation Name: Varicella-Zoster virus Serological Reagents Regulatory Class: Class II Product Code: LFY Dated: January 21, 2007 Received: February 6, 2007
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
10
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).
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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sajastor
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
670317 510(k) Number (if known):
Device Name: Zeus Scientific Varicella Zoster Virus IgM ELISA Test System
Indications For Use:
The Zeus Scientific Varicella Zoster Virus (VZV) IgM ELISA Test System is intended for the qualitative detection of IgM class antibodies to Varicella Zoster Virus in human serum as an aid in the diagnosis of primary infection or reactivation.
The assay performance in detecting antibodies to VZV in individuals vaccinated with the FDA licensed VZV vaccine is unknown.
The user of this assay is responsible for establishing the performance characteristics with VZV vaccinated individuals.
The assay performance in detecting antibodies to VZV in cord blood and neonates has not been established.
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)
Uwe Scheff
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Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K070317