(287 days)
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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 and interpretation of color intensity. The performance studies focus on agreement with a reference method (Western Blot) and an alternate ELISA, not on the performance of an AI/ML model.
No
This device is an in vitro diagnostic (IVD) kit used for qualitative detection of antibodies to aid in the diagnosis of HSV infection. It does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" states that the test is "indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection." Additionally, the "Device Description" states it "may be used as an aid in the diagnoses of Herpes infection" and is "For In Vitro Diagnostic Use Only."
No
The device is an Enzyme-linked Immunosorbent Assay (ELISA) kit, which is a laboratory test that involves physical reagents and a microtiter plate, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The device description clearly states "For In Vitro Diagnostic Use Only."
- Intended Use: The intended use describes the device as an "Enzyme-linked Immunosorbent Assay (ELISA) intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 in human serum." This involves testing biological samples (human serum) outside of the body to provide information for diagnosis.
- Device Description: The description details a laboratory test procedure involving reagents, incubation, washing, and photometric measurement of a color change in a microtiter well, all characteristic of an in vitro diagnostic test.
- Performance Studies: The document includes performance studies evaluating the device's agreement with reference methods (Western Blot and an alternate ELISA) using human serum samples, which is standard for IVD validation.
N/A
Intended Use / Indications for Use
The Captia™ HSV 1 IgG Type Specific kit is an Enzyme-Linked Immunosorbent Assav (ELISA) for the qualitative determination of IgG antibodies in human serum to Herpes simplex Type 1 antigen. The Captia™ HSV 1 IgG Type Specific assay may be used as an aid in the diagnoses of Herpes infection.
For In Vitro Diagnostic Use Only.
The Trinity Biotech Captia™ Herpes Simplex Virus (HSV) 1 Type Specific IgG kit is an Enzyme-linked Immunosorbent Assay (ELISA) intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 in human serum. In conjunction with the Trinity Biotech Captia™ Herpes Simplex Virus (HSV) 2 Type Specific IgG kit, the test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. Due to the implications of positive results, it is recommended they be confirmed in a low prevalence population with Western blot. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, for testing of immunocompromised patients, or for use with automated equipment. The user is responsible for establishing assay performanace in these populations and with automated equipment.
Product codes (comma separated list FDA assigned to the subject device)
MXJ
Device Description
The Captia™ HSV 1 IgG Type Specific test is an Enzyme-Linked Immunosorbent assay to detect IgG antibodies to Herpes simplex 1 antigen. Purified recombinant HSV gG1 antigen is attached to a solid phase microtiter well. Diluted test sera is 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. If antibody is present, it will bind to the antibody attached to the antigen on the 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 an 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
The test is indicated for testing sexually active adults or expectant mothers.
The performance of this assay has not been established for use in a pediatric population.
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)
Perfomance Characteristics % Agreement Positive and % Agreement Negative with Expectant Mothers
An outside investigator assessed the % agreement negative with consented, coded, unselected, banked and masked sera from expectant mothers (n = 210). The reference method was an HSV 1 Western Blot (WB) from a Pacific Northwest university. Of 155 WB positives, Trinity ELISA was 136 positive, 18 negative and 1 equivocal. Of 55 WB negatives, Trinity ELISA was 54 negative and 1 positive.
% agreement positive to WB: 87.74% (136/155) [95% CI: 82.6-92.9%]
% agreement negative to WB: 98.18% (54/55) [95% CI: 90.3-100.0%]
% Agreement Positive and % Agreement Negative with Sexually Active Adults
An outside investigator assessed the % agreement positive and % agreement negative with consented, unselected and masked sera from sexually active adults over the age of 14 (n = 198). The reference method was an HSV 1 Western Blot (WB) from a Pacific Northwest university. Of 116 WB positives, Trinity ELISA was 102 positive and 14 negative. Of 80 WB negatives, Trinity ELISA was 80 negative.
% agreement positive to WB: 87.93% (102/116) [95% CI: 82.0-93.9%]
% agreement negative to WB: 100.00% (80/80) [95% CI: 95.5-100.0%]
% Agreement Positive and % Agreement Negative with a Low Prevalence Population
An outside investigator assessed the % agreement negative with unselected, banked and masked sera from a low prevalence population (n = 184). The reference method was an HSV 1 Western Blot (WB) from a Pacific Northwest university. Of 131 WB negatives, Trinity ELISA was 128 negative, 1 positive and 2 equivocal. Of 53 WB positives, Trinity ELISA was 42 positive, 8 negative and 3 equivocal.
% agreement positive to WB: 79.25% (42/53) [95% CI: 65.9-89.2%]
% agreement negative to WB: 97.71% (128/131) [95% CI: 93.5-99.5%]
% Agreement Positive with Culture Positives
An outside investigator assessed the % agreement positive using unselected, retrospective and masked sera from patients that were at least six weeks but not more than one year post clinical presentation and culture (n = 53). Reference methods included culture (infection) and an HSV 1 Western Blot (WB) (antibody) from a Pacific Northwest university. Of 53 culture positives: 1) Trinity ELISA was 37 positive and 4 equivocal and, 2) WB was 44 positive and 9 negative. Of 44 WB positives: Trinity ELISA was 36 positive, and 2 equivocal.
% agreement positive to culture: 69.81% (37/53) [95% CI: 55.7-81.7%]
% agreement positive to WB: 81.82% (36/44) [95% CI: 67.3-91.8%]
% Agreement Positive and % Agreement Negative to Alternate HSV 1 Type Specific IgG ELISA
An outside investigator at a Pacific Northwest University assessed the 10 % agreement negative of the Trinity Biotech Captia™ HSV 1 Type Specific IgG kit and an alternate HSV 1 type specific IgG ELISA test with 200 prospective, unselected, sequentially submitted specimens.
Percent Positive Agreement: 93.88% (92 / 98) [95% CI: 87.2 - 97.7%]
Percent Negative Agreement: 97.06% (99 / 102) [95% CI: 91.6 - 99.4 %]
Percent Agreement: 95.50% (191 / 200) [95% CI: 91.6 - 97.9 %]
Type Specificity with HSV 2 Western Blot Positives
An outside investigator at a Pacific Northwest University assessed the type specificity using HSV 2 Western Blot positive and HSV 1 Western Blot negative sera from the above described populations (n = 56): expectant mothers, sexually active adults, low prevalence persons, and HSV 2 culture positives. Of 56 HSV 2 Western Blot positive and HSV 1 Western Blot negative samples, Trinity ELISA was 54 negative and 2 positive.
Type-specificity relative to WB: 96.4% (54/56) [95% CI: 87.7-99.6%]
Type cross-reactivity relative to WB: 3.6% (2/56) [95% CI: 0.43-12.3%]
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Western Blot
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
K0331A5
JUL 1 3 2004
Summary of Safety and Effectiveness Information CaptiaTM HSV 1 IgG Type Specific ELISA Test Kit
- I. Trinity Biotech USA 2823 Girts Rd. Jamestown, NY 14701 Contact Person: Bonnie B. DeJoy Telephone: 716-483-3851 Date of Preparation: July 9, 2004
II. Description of Device
The Captia™ HSV 1 IgG Type Specific kit is an Enzyme-Linked Immunosorbent Assav (ELISA) for the qualitative determination of IgG antibodies in human serum to Herpes simplex Type 1 antigen. The Captia™ HSV 1 IgG Type Specific assay may be used as an aid in the diagnoses of Herpes infection
For In Vitro Diagnostic Use Only.
The Captia™ HSV 1 IgG Type Specific test is an Enzyme-Linked Immunosorbent assay to detect IgG antibodies to Herpes simplex 1 antigen. Purified recombinant HSV gG1 antigen is attached to a solid phase microtiter well. Diluted test sera is 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. If antibody is present, it will bind to the antibody attached to the antigen on the 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 an indirect measurement of specific antibody in the patient specimen.
III. Predicate Device
The CaptiaTM HSV 1 IgG Type Specific test is substantially equivalent to Western Blot. Equivalence is demonstrated by the following comparative results:
1
Perfomance Characteristics % Agreement Positive and % Agreement Negative with Expectant Motherst
An outside investigator assessed the % agreement negative with consented, coded, unselected, banked and masked sera from expectant mothers (n = 210). The reference method was an HSV 1 Western Blot ( WB) from a Pacific Northwest university. Of 155 WB positives, Trinity ELISA was 136 positive, 18 negative and 1 equivocal. Of 55 WB negatives, Trinity ELISA was 54 negative and 1 positive.
% Agreement Positive and % Agreement Negative with Expectant Mothers (n = 210)†
| Characteristic | % (EL/WB)* | 95% Confidence Interval (CI) |
|---|---|---|
| % agreement positive to WB | 87.74% (136/155) | 82.6-92.9%‡ |
| % agreement negative to WB | 98.18% (54/55) | 90.3-100.0% |
† The word "% agreement' refers to comparing this assay's results with those of a similar assay. No attempt was made to correlate the assay results to disence. No judgment can be made on the similar assay's accuracy in predicting disease.
- 95% CI calculated using the normal approximate method.
% Agreement Positive and % Agreement Negative with Sexually Active Adultst
An outside investigator assessed the % agreement positive and % agreement negative with consented, unselected and masked sera from sexually active adults over the age of 14 (n = 198). The reference method was an HSV 1 Western Blot (WB) from a Pacific Northwest university. Of 116 WB positives, Trinity ELISA was 102 positive and 14 negative. Of 80 WB negatives, Trinity ELISA was 80 negative.
% Agreement Positive and % Agreement Negative with Sexually Active Adults (n = 198)†
| Characteristic | % (EL/WB)* | 95% Confidence Interval (CI) |
|---|---|---|
| % agreement positive to WB | 87.93% (102/116) | 82.0-93.9%‡ |
| % agreement negative to WB | 100.00% (80/80) | 95.5-100.0% |
-
Excludes two atypical Western Blots.
-
The word "% agreement" refers to comparing this assay's results with those of a similar assay. No attempt was made to correlate the assay results to disence. No judgment can be made on the similar assay's accuracy in predicting disease,
$ 95% CI calculated using the normal approximate method.
% Agreement Positive and % Agreement Negative with a Low Prevalence Population (n = 184)†
An outside investigator assessed the % agreement negative with unselected, banked and masked sera from a low prevalence population (n = 184). The reference method was an HSV 1 Western Blot (WB) from a Pacific Northwest university. Of 131 WB negatives, Trinity ELISA was 128 negative, 1 positive and 2 equivocal. Of 53 WB positives, Trinity ELISA was 42 positive, 8 negative and 3 equivocal.
% Agreement Positive and % Agreement Negative with a Low Prevalence Population (n = 184)†
| Characteristic | % (EL/WB)* | 95% Confidence Interval (CI) |
|---|---|---|
| % agreement positive to WB | 79.25% (42/53) | 65.9-89.2% |
| % agreement negative to WB | 97.71% (128/131) | 93.5-99.5% |
f The word "% agreement" refers to comparing this assay's results with those of a similar assay. No attempt was nade to correlate the assay results to disence. No judgment can be made on the similar assay's accuracy in predicting disease.
2
% Agreement Positive with Culture Positivest
An outside investigator assessed the % agreement positive using unselected, retrospective and masked sera from patients that were at least six weeks but not more than one year post clinical presentation and culture (n = 53). Reference methods included culture (infection) and an HSV 1 Western Blot (WB) (antibody) from a Pacific Northwest university. Of 53 culture positives: 1) Trinity ELISA was 37 positive and 4 equivocal and, 2) WB was 44 positive and 9 negative. Of 44 WB positives: Trinity ELISA was 36 positive, and 2 equivocal.
| Characteristic | % (EL/WB or Culture) | 95% Confidence Interval (CI) |
|---|---|---|
| % agreement positive to culture | 69.81% (37/53) | 55.7-81.7% |
| % agreement positive to WB | 81.82% (36/44) | 67.3-91.8% |
% Agreement Positive with Culture Positives (n = 53)t
† The word "% agreement" refers to comparing this assay's results with those of a similar assay. No attempt was made to correlate the assay results to disence. No judgment can be made on the similar assay's accuracy in predicting disease.
% Agreement Positive and % Agreement Negative to Alternate HSV 1 Type Specific IgG ELISA
An outside investigator at a Pacific Northwest University assessed the 10 % agreement negative of the Trinity Biotech Captia™ HSV 1 Type Specific IgG kit and an alternate HSV 1 type specific IgG ELISA test with 200 prospective, unselected, sequentially submitted specimens.
| Prospectively Collected, Sequential Sera | Alternate HSV 1 Type Specific IgG | |||
|---|---|---|---|---|
| + | - | E | ||
| Trinity Biotech Captia | ||||
| HSV 1 Type Specific | + | 92 | 3 | 0 |
| - | 6 | 99 | 0 | |
| E | 0 | 0 | 0 |
| Characteristic | % (TBU ELISA / Alt.
ELISA) | 95% Confidence
Interval (CI) |
|-------------------------------|-------------------------------|---------------------------------|
| Percent Positive
Agreement | 93.88% (92 / 98) | 87.2 - 97.7% |
| Percent Negative
Agreement | 97.06% (99 / 102) | 91.6 - 99.4 % |
| Percent Agreement | 95.50% (191 / 200) | 91.6 - 97.9 % |
Type Specificity with HSV 2 Western Blot Positives
An outside investigator at a Pacific Northwest University assessed the type specificity using HSV 2 Western Blot positive and HSV 1 Western Blot negative sera from the above described populations (n = 56): expectant mothers, sexually active adults, low prevalence persons, and HSV 2 culture positives. Of 56 HSV 2 Western Blot positive and HSV 1 Western Blot negative samples, Trinity ELISA was 54 negative and 2 positive.
| Characteristic | % (EL/WB) | 95% Confidence Interval (CI) |
|---|---|---|
| Type-specificity relative to WB | 96.4% (54/56) | 87.7-99.6% |
| Type cross-reactivity relative to WB | 3.6% (2/56) | 0.43-12.3% |
Type Specificity with HSV 2 Western Blot Positives (n = 56)
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A."
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 1 3 2004
Ms. Bonnie B. DeJoy Director of Quality Systems Trinity Biotech USA 2823 Girts Road Jamestown, NY 14701
Re: K033105
Trade/Device Name: CaptiaTM HSV 1 IgG Type Specific ELISA Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes Simplex Virus Serological Reagents Regulatory Class: Class III Product Code: MXJ Dated: April 20, 2004 Received: April 21, 2004
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 (QS) regulation (21 CFR Part 820).
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Page 2
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). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Salartys
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
5
510(k) Number: K033105 Device Name: Captia™ HSV 1 IgG Type Specific ELISA
Indications for Use:
The Trinity Biotech Captia™ Herpes Simplex Virus (HSV) 1 Type Specific IgG kit is an Enzyme-linked Immunosorbent Assay (ELISA) intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 in human serum. In conjunction with the Trinity Biotech Captia™ Herpes Simplex Virus (HSV) 2 Type Specific IgG kit, the test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. Due to the implications of positive results, it is recommended they be confirmed in a low prevalence population with Western blot. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, for testing of immunocompromised patients, or for use with automated equipment. The user is responsible for establishing assay performanace in these populations and with automated equipment
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Reeder Jr. Poole
Division Sign Off
Division Sign-Off
Office of to Vitro Diagnostic Device Evaluation and Safe
510(k) KD33105/51
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