(245 days)
No
The device description details a standard ELISA assay, which is a biochemical method for detecting antibodies. There is no mention of AI, ML, or any computational analysis beyond basic photometric measurement of color intensity.
No.
This device is an in-vitro diagnostic test, designed to detect antibodies to herpes simplex virus, which aids in diagnosis rather than providing treatment or altering a biological function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the test "can aid in the diagnosis of primary infection with herpes simplex virus." It is designed for the "qualitative and/or semi-quantitative detection of IgG antibodies to herpes simplex virus type 1 and/or type 2 in human serum," which is a diagnostic purpose.
No
The device description clearly outlines a physical ELISA kit involving reagents, microtiter wells, and a photometer for detection, indicating it is a hardware-based diagnostic test, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the kit is for the "qualitative and/or semi-quantitative detection of IgG antibodies to herpes simplex virus type 1 and/or type 2 in human serum". 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 (immunological response to HSV infection).
- Device Description: The description details a laboratory test method (ELISA) performed on a biological sample (diluted patient serum).
- Performance Studies: The performance studies involve testing human serum samples and comparing the results to other diagnostic kits.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The INCSTAR Herpes Simplex Virus I/II IgG "fast" ELISA kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgG antibodies to herpes simplex virus type 1 and/or type 2 in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the INCSTAR Herpes Simplex Virus I/II IgG "fast" ELISA test is of value in the determination of immunological response to infection with HSV. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of primary infection with herpes simplex virus.
Product codes
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Device Description
The method for the determination of specific anti-HSV type 1 and/or type 2 IgG utilizes the enzyme-linked immunosorbent assay (ELISA) technique. Polystyrene microtiter wells are coated with purified HSV type 1 and type 2 antigens. Diluted patient serum is incubated with the purified HSV antigens bound to the solid surface of the microtiter well. The HSV type 1 and/or type 2 IgG antibodies present in a patient's serum will be captured by the solid phase. After washing, affinity purified polyclonal goat anti-human IgG (Fc) antibodies conjugated to horseradish peroxidase are added to the well. After this incubation, chromogen containing tetramethylbenzidine is added. Enzyme action on the chromogen results in a color reaction. The color can be detected with a photometer at a wavelength of 450 nm. The measured enzyme activity is directly proportional to the concentration of specific anti-HSV IgG bound to the solid phase.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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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
In clinical performance studies, 305 serum samples represented by 305 individuals were tested with the INCSTAR HSV I/II IgG "fast" ELISA Kit and results were compared to those results generated from the Herpes 1 IgG Clin-ELISA and Herpes 2 IgG Clin-ELISA kits. The samples utilized represent a mixed population of healthy individuals, transplant patients, and patients with various illnesses.
Summary of Performance Studies
Clinical performance studies were conducted using 305 serum samples from 305 individuals. The INCSTAR HSV I/II IgG "fast" ELISA Kit results were compared to results from the Herpes 1 IgG Clin-ELISA and Herpes 2 IgG Clin-ELISA kits. Relative sensitivity was 94% to 99%, relative specificity was 85% to 95%, and overall agreement was 90% to 100% (using 95% confidence intervals). Discrepant results were further resolved by a commercial HSV IgG IFA. Out of 13 samples positive by INCSTAR but negative by reference ELISAs, 11 were positive by IFA. Out of 4 samples negative by INCSTAR but positive by reference ELISAs, 1 was negative by IFA. Prevalence, cross-reactivity, interference, linearity and precision studies were also conducted.
Key Metrics
Relative sensitivity of 94% to 99%, a relative specificity of 85% to 95%, and an overall agreement of 90% to 100%.
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 864.4010 General purpose reagent.
(a) A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test. General purpose reagents are appropriate for combining with one or more than one ASR in producing such systems and include labware or disposable constituents of tests; but they do not include laboratory machinery, automated or powered systems. General purpose reagents include cytological preservatives, decalcifying reagents, fixative and adhesives, tissue processing reagents, isotonic solutions and pH buffers. Reagents used in tests for more than one individual chemical substance or ligand are general purpose reagents (e.g.,
Thermus aquaticus (TAQ) polymerase, substrates for enzyme immunoassay (EIA)).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
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سسيد
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JUL 24 1996
I. SUMMARY OF SAFETY AND EFFECTIVENESS
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SUMMARY OF SAFETY AND EFFECTIVENESS ﮯ
| DEVICE NAME: | INCSTAR HSV I/II IgG "fast" ELISA Kit |
|---|---|
| CLASSIFICATION: | Herpes simplex virus serological reagents |
| 21 CFR 866.3305 | |
| Class III | |
| APPLICANT: | INCSTAR Corporation |
| 1990 Industrial Boulevard | |
| Stillwater, Minnesota 55082-0285 |
INTENDED USE:
The INCSTAR Herpes Simplex Virus I/II IgG "fast" ELISA kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgG antibodies to herpes simplex virus type 1 and/or type 2 in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the INCSTAR Herpes Simplex Virus I/II IgG "fast" ELISA test is of value in the determination of immunological response to infection with HSV. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of primary infection with herpes simplex virus.
DEVICE DESCRIPTION:
The method for the determination of specific anti-HSV type 1 and/or type 2 IgG utilizes the enzyme-linked immunosorbent assay (ELISA) technique. Polystyrene microtiter wells are coated with purified HSV type 1 and type 2 antigens. Diluted patient serum is incubated with the purified HSV antigens bound to the solid surface of the microtiter well. The HSV type 1 and/or type 2 IgG antibodies present in a patient's serum will be captured by the solid phase. After washing, affinity purified polyclonal goat anti-human IgG (Fc) antibodies conjugated to horseradish peroxidase are added to the well. After this incubation, chromogen containing tetramethylbenzidine is added. Enzyme action on the chromogen results in a color reaction. The color can be detected with a photometer at a wavelength of 450 nm. The measured enzyme activity is
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. SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
directly proportional to the concentration of specific anti-HSV IgG bound to the solid phase.
SAFETY AND EFFECTIVENESS:
The INCSTAR HSV I/II IgG "fast" ELISA Kit is substantially equivalent (SE) to the Herpes 1 IgG Clin-ELISA kit, 510(k) No. K852782 in combination with the Herpes 2 IgG Clin-ELISA kit, 510(k) No. K852781 which have been cleared by the FDA and are currently in U.S. commercial distribution.
In clinical performance studies, 305 serum samples represented by 305 individuals were tested with the INCSTAR HSV I/II IgG "fast" ELISA Kit and results were compared to those results generated from the Herpes 1 IgG Clin-ELISA and Herpes 2 IgG Clin-ELISA kits. The samples utilized represent a mixed population of healthy individuals, transplant patients, and patients with various illnesses. Upon completion of assay correlation, the results (using 95% confidence intervals) demonstrated a relative sensitivity of 94% to 99%, a relative specificity of 85% to 95%, and an overall agreement of 90% to 100%.
Further resolution of discrepant results by a commercial HSV IgG IFA demonstrated that of the 13 samples positive by the INCSTAR HSV I/II IgG "fast" assay but negative by the reference ELISA assays, 11 were positive by IFA. Of the 4 samples negative by the INCSTAR HSV I/II IgG "fast" assay but positive by the reference ELISA assays, 1 was negative by IFA.
Prevalence, cross-reactivity, interference, linearity and precision studies have been conducted and are summarized in the INCSTAR HSV I/II IgG "fast" ELISA Kit package insert. (See Section VII.A.1. Package Insert).
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