(154 days)
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No
The description details a standard enzyme immunoassay (EIA) process with photometric reading. There is no mention of AI or ML in the device description, intended use, or performance studies. The analysis is based on a direct chemical reaction and optical measurement, not algorithmic interpretation of complex data.
No.
The device is used for diagnostic purposes (detection of antibodies to aid in assessment of immunological response), not for treating or curing a disease.
Yes
This device detects human IgG antibodies to herpes simplex virus (type 1 or type 2) in human serum to aid in assessing the patient's immunological response, which is a diagnostic function.
No
The device description clearly outlines a solid-phase enzyme immunoassay (EIA) which involves physical reagents, microwells, incubations, washing, and photometric reading. This is a hardware-based laboratory test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For the qualitative and semi-quantitative detection of human IgG antibodies to herpes simplex virus (type 1 or type 2) in human serum by enzyme immunoassay, to aid in the assessment of the patient's immunological response to herpes simplex virus." This describes a test performed on a sample taken from the human body (serum) to provide information about a person's health status (presence of antibodies to HSV).
- Device Description: The description details a "solid-phase enzyme immunoassay (EIA), which is performed in microwells" and involves detecting antibodies in human serum. This is a typical description of an in vitro diagnostic test.
- Performance Studies: The document describes performance studies using human serum samples (CDC panel, randomly obtained specimens) to evaluate the device's ability to detect HSV antibodies. This is a requirement for demonstrating the performance of an IVD.
- Comparison to Predicate Device: The comparison testing with a "Predicate Device" (HSV-1 and HSV-2 Clin-ELISA™ kits) further indicates that this device is intended to perform a diagnostic function similar to existing IVDs.
The definition of an In Vitro Diagnostic (IVD) is a medical device that is intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
This device clearly fits this definition.
N/A
Intended Use / Indications for Use
For the qualitative and semi-quantitative detection of human IgG antibodies to herpes simplex virus (type 1 or type 2) in human serum by enzyme immunoassay, to aid in the assessment of the patient's immunological response to herpes simplex virus. For manual use, or for use with the HyPrep System Plus. These reagents have not received FDA clearance for use in testing blood or plasma donors.
Product codes
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Device Description
The SeraQuest™ HSV IqG test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgG antibodies which are directed against type 1 or type 2 herpes simplex virus (HSV), in human serum.
The Calibrators in the SeraQuest HSV IgG test set have been assigned Index values based on an in-house standard. Test results are normalized and reported as Index values.
Principle: Diluted samples are incubated in wells coated with Type 2 herpes simplex virus. HSV antibodies (if present) are immobilized in the wells. Residual sample is eliminated by washing and draining, and conjugate (enzyme-labeled antibodies to human IgG) is added and incubated. If IgG antibodies to HSV are present, the conjugate will be immobilized in the wells. Residual conjugate is eliminated by washing and the enzyme substrate is added and incubated. In the presence of the enzyme, the substrate is converted to a yellow end-product which is read photometrically.
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
human serum
Indicated Patient Age Range
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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
Summary of Test Results Obtained with the Centers for Disease Control and Prevention HSV / CMV evaluation panel
The following information was obtained with the Centers for Disease Control and Prevention (CDC) serum panel for HSV / CMV serology assays, which was tested in-house by the SeraQuest™ HSV The results are presented here as a means to convey further information on the IgG test. performance of this assay with a masked, characterized serum panel. This does not imply an endorsement by the CDC.
The panel consists of 72 % positive and 28 % negative samples.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Test Results Obtained with the Centers for Disease Control and Prevention HSV / CMV evaluation panel
The SeraQuest HSV IgG Test demonstrated 95 % total agreement with the CDC results. Of the results obtained by SeraQuest, there was 93 % agreement with the positive specimens, and 100 % agreement with the negative specimens.
Comparison testing with the Predicate Device
Two hundred and seven serum specimens, which were randomly obtained in South Florida were assayed by the SeraQuest HSV IgG test and a predicate device which utilizes antigen wells coated with non-specific type 1, or type 2 HSV antigens. The results of these assays are shown below in Table 1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
INCSTAR HERPES IgG TYPE 1
Relative sensitivity√: 99.5 to 100
Relative specificity√: 59.6 to 86.7
Overall agreement√: 91.3 to 97.6
INCSTAR HERPES IgG TYPE 2
Relative sensitivity√: 99.5 to 100
Relative specificity√: 51.5 to 79.0
Overall agreement√: 88.2 to 95.7
INCSTAR HERPES IgG TYPE 1 & TYPE 2
Relative sensitivity√: 99.5 to 100
Relative specificity√: 59.6 to 86.7
Overall agreement√: 91.3 to 97.6
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.
The SeraQuest™ HSV IgG test is substantially equivalent in intended use and performance, to the HSV-1 and HSV-2 Clin-ELISA™ kits, INCSTAR Corporation, Stillwater Minnesota.
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.
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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).
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§ 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
APPENDIX 5.
JAN 2 2 1997
KA63282
510(k) SUMMARY
| Applicant: | Quest International, Inc.
1938 N.E. 148th Terrace
North Miami, FL 33181 |
|------------------------|-------------------------------------------------------------------------------|
| Registration No. | 1061839 |
| Contact Person: | Robert A. Cort, President |
| Telephone: | (305) 948-8788 |
| Telefax: | (305) 948-4876 |
| Manufacturing Site: | Same as above |
| Device: | SeraQuest™ HSV IgG |
| Device Name: | Herpes Simplex Virus serological reagents (21CFR § 866.3305) |
| Device Classification: | Class III (premarket approval) |
Ascription:
The SeraQuest™ HSV IqG test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgG antibodies which are directed against type 1 or type 2 herpes simplex virus (HSV), in human serum.
The Calibrators in the SeraQuest HSV IgG test set have been assigned Index values based on an in-house standard. Test results are normalized and reported as Index values.
Principle:
Diluted samples are incubated in wells coated with Type 2 herpes simplex virus. HSV antibodies (if present) are immobilized in the wells. Residual sample is eliminated by washing and draining, and conjugate (enzyme-labeled antibodies to human IgG) is added and incubated. If IgG antibodies to HSV are present, the conjugate will be immobilized in the wells. Residual conjugate is eliminated by washing and the enzyme substrate is added and incubated. In the presence of the enzyme, the substrate is converted to a yellow end-product which is read photometrically.
1
Intended Use:
For the qualitative and semi-quantitative detection of human IgG antibodies to herpes simplex virus (type 1 or type 2) in human serum by enzyme immunoassay, to aid in the assessment of the patient's immunological response to herpes simplex virus. For manual use, or for use with the HyPrep System Plus. These reagents have not received FDA clearance for use in testing blood or plasma donors.
Predicate device:
The SeraQuest™ HSV IgG test is substantially equivalent in intended use and performance, to the HSV-1 and HSV-2 Clin-ELISA™ kits, INCSTAR Corporation, Stillwater Minnesota.
Summary of technological characteristics:
| Characteristic | SeraQuest™ HSV IgG | INCSTAR Herpes Type 1 and
Type 2 Clin-ELISA™ |
|--------------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Description: | Enzyme Immunoassay | Enzyme Immunoassay |
| ended Use: | Detection of IgG antibodies
against type 1 HSV and type 2
HSV, in human serum. | Detection of IgG antibodies
against type 1 HSV or type 2
HSV, in human serum. |
| Solid Phase: | Plastic Microwell | Plastic Microwell |
| Antigen Strain: | Type 1: MacIntyre
Type 2: MS | Type 1: Macintyre
Type 2: MS |
| Number of Incubation Periods: | Three | Three |
| Sample Dilution: | 1:50 | 1:50 |
| Sample Incubation
Duration: | 30 minutes | 30 minutes |
| Incubation Temperature: | Room temperature | Room temperature |
| Ezyme-labeled Conjugate: | | |
| Antibody | Goat anti-human IgG
(gamma chain specific) | Goat or Sheep anti-human IgG
(gamma chain specific) |
| Enzyme | Alkaline phosphatase | Alkaline phosphatase |
| onjugate Volume: | 100 µl | 200 μl |
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Page No. 258
200 μl 100 ul Subtrate Volume: 45 minutes Substrate Incubation 30 minutes Duration: 3 N Sodium Stop Reagent: 0.5 M Trisodium Hydroxide phosphate 50 ul Stop Reagent Volume: 100 μl Spectrophotometric Readout: Spectrophotometric 405 nm 405 nm
Summary of Test Results Obtained with the Centers for Disease Control and Prevention HSV / CMV evaluation panel
ye following information was obtained with the Centers for Disease Control and Prevention (CDC) serum panel for HSV / CMV serology assays, which was tested in-house by the SeraQuest™ HSV The results are presented here as a means to convey further information on the IgG test. performance of this assay with a masked, characterized serum panel. This does not imply an endorsement by the CDC.
The panel consists of 72 % positive and 28 % negative samples. The SeraQuest HSV IgG Test demonstrated 95 % total agreement with the CDC results. Of the results obtained by SeraQuest, there was 93 % agreement with the positive specimens, and 100 % agreement with the negative specimens.
Comparison testing with the Predicate Device
Two hundred and seven serum specimens, which were randomly obtained in South Florida were assayed by the SeraQuest HSV IgG test and a predicate device which utilizes antigen wells coated with non-specific type 1, or type 2 HSV antigens. The results of these assays are shown below in Table 1.
3
TABLE 1.
RESULTS OF SeraQuest™ HSV IgG ASSAYS (USING THE REVISED CUT-OFF VALUES AS PER C.D.C.), AND ANOTHER COMMERCIALLY (VALABLE HSV IgG ASSAY, OF 207 SEHUM SPECIMENS. THE TEST SPECIMENS, WHICH INCLUDED 40 FROM WOMEN OF CHILD BEARING AGE (18 TO 45 YEARS), WERE COLLECTED IN SOUTH FLORIDA, AND TESTED AT QUEST INTERNATIONAL, INC., MÍAMI, FL.
| SeraQuest HSV IgG | |||||
|---|---|---|---|---|---|
| INCSTAR | |||||
| HERPES IgG | |||||
| TYPE 1 | Positive | Equivocal | Negative | 95 % CI* | |
| Positive | |||||
| Negative | 158 {36} | ||||
| 11 {2} | 0 | ||||
| 8 | 0 | ||||
| 30 {2} | Relative sensitivity√ | ||||
| Relative specificity√ | |||||
| Overall agreement√ | 99.5 to 100 | ||||
| 59.6 to 86.7 | |||||
| 91.3 to 97.6 | |||||
| INCSTAR | |||||
| HERPES IgG | |||||
| TYPE 2 | Positive | Equivocal | Negative | 95 % CI* | |
| Positive | |||||
| Negative | 153 {35} | ||||
| 16 {3} | 0 | ||||
| 8 | 0 | ||||
| 30 {2} | Relative sensitivity√ | ||||
| Relative specificity√ | |||||
| Overall agreement√ | 99.5 to 100 | ||||
| 51.5 to 79.0 | |||||
| 88.2 to 95.7 | |||||
| INCSTAR | |||||
| HERPES IgG | |||||
| TYPE 1 & TYPE 2 | Positive | Equivocal | Negative | 95 % CI* | |
| Positive | |||||
| Negative | 158 {36} | ||||
| 11 {2} | 0 | ||||
| 8 | 0 | ||||
| 30 {2} | Relative sensitivity√ | ||||
| Relative specificity√ | |||||
| Overall agreement√ | 99.5 to 100 | ||||
| 59.6 to 86.7 | |||||
| 91.3 to 97.6 |
V Excluding equivocal results. Calculated by the normal method.
Number of female donors of childbearing age.