(58 days)
Clark Laboratories, Inc. (Clark) HSV I and HSV II ELISA tests.
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No
The device description details a standard ELISA assay, which is a biochemical test. There is no mention of AI, ML, or any computational analysis beyond basic photometric measurement and calculation of agreement percentages.
No.
This device is an in vitro diagnostic (IVD) test used to determine the presence of antibodies to Herpes simplex virus, aiding in diagnosis. It does not provide any form of therapy or treatment.
Yes
This device, the Trinity Biotech Captia™ Herpes Group IgG ELISA kit, is explicitly described as an aid in the diagnosis of Herpes simplex virus infection and for determining serologic status. Its purpose is to detect IgG antibodies in human serum, which provides information about a patient's health condition related to a specific disease.
No
The device description clearly outlines a physical ELISA kit involving reagents, microtiter wells, and photometric measurement, indicating it is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative determination of IgG antibodies in human serum to Herpes simplex virus." It also mentions its use "as an aid in the diagnosis of Herpes simplex virus infection." This clearly indicates it's used to test human specimens (serum) to provide information for diagnostic purposes.
- Device Description: The description details a laboratory test (ELISA) performed on human serum to detect antibodies. This aligns with the definition of an in vitro diagnostic device.
- Performance Studies: The document includes performance characteristics based on testing human serum samples, comparing results to a predicate device. This is typical for IVD submissions.
The device is designed to be used in vitro (outside the body) to examine a human specimen (serum) to provide information about a person's health status (presence of Herpes simplex virus antibodies). This directly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Trinity Biotech Captia™ Herpes Group IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative determination of IgG antibodies in human serum to Herpes simplex virus. The Herpes Group IgG ELISA kit may be used to determine serologic status in females of child bearing age, and to evaluate paired sera for the presence of a seroconversion of IgG as an aid in the diagnosis of Herpes simplex virus infection. It is not intended for determining the type of Herpes simplex virus.
Product codes
LGC
Device Description
The Herpes Group IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative determination of IgG antibodies in human serum to Herpes simplex virus. The Herpes Group IgG ELISA kit may be used to evaluate paired sera for the presence of seroconversions of IgG as an aid in the diagnosis of Herpes simplex virus infection.
The Herpes Group IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Herpes simplex virus. Purified Herpes Group antigen is attached to a solid phase microtiter well. Diluted test sera are added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation, the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. After incubation, the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present, the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing and indirect measurement of specific antibody in the patient specimen.
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
females of child bearing age, and from patients suspected of having acute Herpes simplex infection
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison Studies:
- Study 1: R&D laboratory at a commercial company in Maryland. Frozen sera from normals, ages 12-83, various gender and geographical areas.
- Sample Size: 187
- % Agreement positive = 104/105 = 99.1% (95% CI: 97.2% - 100%)
- % Agreement negative = 73/76 = 94.7% (95% CI: 89.6% - 99.9%)
- Total % Agreement = 176/181 = 97.2% (95% CI: 94.8% - 100%)
- Study 2: R&D laboratory at a commercial company in New York. Frozen sera from normals, ages 17-59, various gender and geographical areas.
- Sample Size: 152
- % Agreement positive = 92/94 = 97.9% (95% CI: 94.9% - 100%)
- % Agreement negative = 51/51 = 100% (95% CI: 94.2% - 100%)
- Total % Agreement = 143/145 = 98.6% (95% CI: 96.7% - 100%)
- Study 3: Clinical laboratory in Pennsylvania. Prospective samples sent for Herpes antibody testing.
- Sample Size: 176
- % Agreement positive = 112/113 = 99.1% (95% CI: 97.4% - 100%)
- % Agreement negative = 54/57 = 94.7% (95% CI: 88.8% - 100%)
- Total % Agreement = 166/170 = 97.7% (95% CI: 95.3% - 100%)
- Study 4: Clinical laboratory in Wisconsin. Frozen random normal samples.
- Sample Size: 88
- % Agreement positive = 62/62 = 100% (95% CI: 95.3% - 100%)
- % Agreement negative = 25/26 = 96.2% (95% CI: 96.2% - 100%)
- Total % Agreement = 87/88 = 98.9% (95% CI: 98.9% - 100%)
Overall Comparison Results (Combined Studies 1-4):
- Sample Size: 603
- % Agreement positive = 370/374 = 98.9% (95% CI: 97.9% - 100%)
- % Agreement negative = 203/210 = 96.7% (95% CI: 94.2% - 99.1%)
- Total % Agreement = 573/584 = 98.1% (95% CI: 97.0% - 99.2%)
Precision Study:
- Type: Inter-site precision study
- Sample Size: 7 sera, assayed 10 times each on 3 different assays at 3 different sites (n = 90 for each sera).
- Key results: CV values ranged from 9.08% to 150%. With appropriate technique, the user should obtain precision of
§ 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).
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Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters, specifically "K033059". The characters are written in a handwritten style, with varying stroke thicknesses. The numbers are clearly distinguishable, and the overall image appears to be a close-up of the characters.
Summary of Safety and Effectiveness Information Herpes Group IgG ELISA Test Kit
- I. Trinity Biotech 2823 Girts Road Jamestown, NY 14701 Contact person: Bonnie B. DeJoy Telephone: 716-483-3851 Date of preparation: Nov. 20, 2003
II. Description of Device
The Herpes Group IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative determination of IgG antibodies in human serum to Herpes simplex virus. The Herpes Group IgG ELISA kit may be used to evaluate paired sera for the presence of seroconversions of IgG as an aid in the diagnosis of Herpes simplex virus infection.
The Herpes Group IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Herpes simplex virus. Purified Herpes Group antigen is attached to a solid phase microtiter well. Diluted test sera are added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation, the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. After incubation, the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present, the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing and indirect measurement of specific antibody in the patient specimen.
III. Predicate Device
The Herpes Group IgG ELISA test is substantially equivalent to Clark Laboratories, Inc. (Clark) HSV I and HSV II ELISA tests. Equivalence is demonstrated by the following comparative results:
Performance Characteristics
- % Agreement Positive and % Agreement Negative. Four different sites compared the Trinity Biotech Herpes Group IgG ELISA test relative to Clark HSVI ELISA assays. The first site was a R&D laboratory at a commercial company located in Maryland. The frozen sera were from normals with ages from 12-83, with various gender and geographical areas. The results of the study are compiled and summarized in Table 1.
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Please be advised the "% agreement positive" and "% agreement negative" refers to the Note: comparison of this assay's results to that of a similar assay. There was not an attempt to correlate the assay's results with disease presence or absence. No judgment can be made on the comparison assay's accuracy to predict disease.
Table 1 Comparison of Herpes Group IgG ELISA and Clark HSV 1 and HSV 2 Study 1
Trinity Biotech Herpes Group IgG ELISA
| + | eq | - | Total | ||
|---|---|---|---|---|---|
| Clark | |||||
| HSV 1 & | |||||
| HSV 2 | +* | 104 | 1 | 1 | 106 |
| eq* | 3 | 0 | 0 | 3 | |
| -*** | 4 | 2 | 72 | 78 | |
| Total | 111 | 3 | 73 | 187 |
| % Agreement positive = 104/105 = 99.1% | 95% Confidence interval = 97.2% - 100% |
|---|---|
| % Agreement negative = 73/76 = 94.7% | 95% Confidence interval = 89.6% - 99.9% |
| % Agreement = 176/181 = 97.2% | 95% Confidence interval = 94.8% - 100% |
Equivocals were not included in the above calculations. The 95% confidence intervals were calculated using the normal method.
- Indicates positive on Clark HSV 1 and/or Clark HSV 2.
** Indicated equivocal on Clark HSV 1 and/or Clark HSV 2.
*** Indicates negative on both Clark HSV 1 and Clark HSV 2.
The second site was a R&D laboratory at a commercial company located in New York. The frozen sera were from normals with ages from 17-59, with various fender and geographical areas. The results of the study are compiled and summarized in Table 2.
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Table 2 Comparison of Herpes Group IgG ELISA and Clark HSV 1 and Clark HSV 2 Study 2
Trinity Biotech Herpes Group IgG ELISA
| + | eq | - | Total | |||
|---|---|---|---|---|---|---|
| Clark | ||||||
| HSV 1 and | ||||||
| HSV 2 | +* | 92 | 6 | 2 | 100 | |
| eq** | 1 | 0 | 0 | 1 | ||
| -*** | 0 | 0 | 51 | 51 | ||
| Total | 93 | 6 | 53 | 152 | ||
| % Agreement positive = 92/94 = 97.9% | 95% Confidence interval = 94.9% - 100% |
95% Confidence interval = 94.2% - 100% % Agreement negative = 51/51 = 100% % Agreement = 143/145 = 98.6% 95% Confidence interval = 96.7% - 100%
Equivocals were not included in the above calculations.
The 95% confidence intervals were calculated using the normal method.
The 95% confidence interval for % agreement positive was calculated assuming one false positive.
- Indicates positive on Clark HSV 1 and/or Clark HSV 2.
** Indicated equivocal on Clark HSV land/or Clark HSV 2.
*** Indicates negative on both Clark HSV 1 Clark HSV 2.
The third site was a clinical laboratory located in Pennsylvania. The sera were prospective samples sent in to the lab for Herpes antibody testing. The results of the studies are compiled and summarized in Table 3.
Table 3 Comparison of Herpes Group IgG ELISA and Clark HSV 1 and Clark HSV 2 Study 3
Trinity Biotech Herpes Group IgG ELISA
| + | eq | - | Total | ||
|---|---|---|---|---|---|
| +* | 112 | 0 | 1 | 113 | |
| Clark | |||||
| HSV 1 and | |||||
| HSV 2 | eq** | 1 | 0 | 1 | 2 |
| -*** | 3 | 4 | 54 | 61 | |
| Total | 116 | 4 | 56 | 176 |
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| % Agreement positive = 112/113 = 99.1% | 95% Confidence interval = 97.4% - 100% |
|---|---|
| % Agreement negative = 54/57 = 94.7% | 95% Confidence interval = 88.8% - 100% |
| % Agreement = 166/170 = 97.7% | 95% Confidence interval = 95.3% - 100% |
Equivocals were not included in the above calculations. The 95% confidence intervals were calculated using the normal method.
The 95% confidence intervals were calculated using the normal method.
- Indicates positive on Clark HSV 1 and/or Clark HSV 2.
** Indicated equivocal on Clark HSV land/or Clark HSV 2.
*** Indicates negative on both Clark HSV 1 Clark HSV 2.
The fourth site was a clinical laboratory located in Wisconsin. The frozen sera were random normal samples. The results of the studies are compiled and summarized in Table 4.
Table 4 Comparison of Herpes Group IgG ELISA and Clark HSV 1 and Clark HSV 2 Study 4
Trinity Biotech Herpes Group IgG ELISA
| + | eq | - | Total | ||
|---|---|---|---|---|---|
| Clark | |||||
| HSV 1 and | |||||
| HSV 2 | +* | 62 | 0 | 0 | 62 |
| eq** | 0 | 0 | 0 | 0 | |
| -*** | 1 | 0 | 25 | 26 | |
| Total | 63 | 0 | 25 | 88 |
| % Agreement positive = 62/62 = 100% | 95% Confidence interval = 95.3% - 100% |
|---|---|
| % Agreement negative = 25/26 = 96.2% | 95% Confidence interval = 96.2% - 100% |
| % Agreement = 87/88 = 98.9% | 95% Confidence interval = 98.9% - 100% |
Equivocals were not included in the above calculations.
The 95% confidence intervals were calculated using the normal method. The 95% confidence interval for % agreement positive was calculated assuming on false positive.
- Indicates positive on Clark HSV 1 and/or Clark HSV 2.
** Indicated equivocal on Clark HSV 1and/or Clark HSV 2.
*** Indicates negative on both Clark HSV 1 Clark HSV 2.
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The results of the four studies are compiled and summarized in Table 5.
Table 5 Comparison of Herpes Group IgG ELISA and Clark HSV 1 and Clark HSV 2
Trinity Biotech Herpes Group IgG ELISA
| + | eq | - | Total | ||
|---|---|---|---|---|---|
| Clark | |||||
| HSV 1 and | |||||
| HSV 2 | +* | 370 | 7 | 4 | 381 |
| eq** | 5 | 0 | 1 | 6 | |
| -*** | 7 | 6 | 203 | 216 | |
| Total | 382 | 13 | 208 | 603 |
| % Agreement positive = 370/374 = 98.9% | 95% Confidence interval = 97.9% - 100% |
|---|---|
| % Agreement negative = 203/210 = 96.7% | 95% Confidence interval = 94.2% - 99.1% |
| % Agreement = 573/584 = 98.1% | 95% Confidence interval = 97.0% - 99.2% |
Equivocals were not included in the above calculations.
The 95% confidence intervals were calculated using the normal method.
- Indicates positive on Clark HSV 1 and/or Clark HSV 2.
** Indicated equivocal on Clark HSV 1and/or Clark HSV 2.
*** Indicates negative on both Clark HSV 1 Clark HSV 2.
- Precision. Seven sera were assayed ten times each on three different assays at three different sites. The intersite precision is shown in Table 6. With appropriate technique the user should obtain precision of Trade/Device Name: Captia Herpes Group IgG ELISA Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes Simplex Virus Serological Reagents Regulatory Class: Class III Product Code: LGC Dated: September 17, 2003 Received: September 29, 2003
Dear Ms. DeJoy:
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 (OS) 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 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,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number: K033059
Device Name: Trinity Biotech Captia™ Herpes Group IgG ELISA
Indications For Use: The Trinity Biotech Captia™ Herpes Group IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative determination of IgG antibodies in human serum to Herpes simplex virus. The Herpes Group IgG ELISA kit may be used to determine serologic status in females of child bearing age, and to evaluate paired sera for the presence of a seroconversion of IgG as an aid in the diagnosis of Herpes simplex virus infection. It is not intended for determining the type of Herpes simplex virus.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-The-Counter Use ______ |
|---|---|---|---|
| (Per 21 XFR 801.109) | (Optional Format 1-2-96) |
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Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K033059