(58 days)
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No
The device is an ELISA kit, which is a laboratory assay based on chemical reactions and photometric measurement, not AI/ML. The description focuses on the biological and chemical components and processes of the assay.
No.
This device is an in vitro diagnostic test designed to detect antibodies in human serum, which is used for diagnosis or to determine immunological experience, not for treating a disease or condition.
Yes
Explanation: The device is an "Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative detection of IgG antibodies in human serum to Chlamydia for the determination of immunological experience." This type of in vitro diagnostic test is used to detect the presence or absence of specific substances (antibodies in this case) in a sample, which aids in the diagnosis of a medical condition (Chlamydia infection).
No
The device is an ELISA kit, which is a laboratory-based in vitro diagnostic test involving physical reagents and a photometric reader, not software alone.
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 IgG antibodies in human serum to Chlamydia for the determination of immunological experience." This is a diagnostic purpose performed on a sample taken from the human body (serum).
- Device Description: The description details a laboratory test (ELISA) performed on human serum to detect specific antibodies. This is the core function of an in vitro diagnostic device.
- Performance Studies: The document includes performance studies (agreement with other methods, precision, reproducibility) which are standard for demonstrating the analytical and clinical performance of an IVD.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. The Trinity Biotech Captia™ Chlamydia IgG ELISA kit clearly fits this definition.
N/A
Intended Use / Indications for Use
The Chlamydia IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative detection of IgG antibodies inhuman serum to Chlamydia for the determination of immunological experience.
The Trinity Biotech Captia™ Chlamydia IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative detection of IgG antibodies in human serum to Chlamydia for the determination of immunological experience.
Product codes
LJC
Device Description
The Chlamydia IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative detection of IgG antibodies inhuman serum to Chlamydia for the determination of immunological experience.
The Chlamydia IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Chlamydia. Purified Chlamydia antigen (strain LGV II) 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. If antibody is preset 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
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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
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Summary of Performance Studies
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% Agreement Positive and % Agreement Negative: Two different sites (R&D laboratories at commercial companies in Maryland and New York, affiliated with the manufacturer) compared the Trinity Biotech Chlamydia IgG ELISA test relative to a commercial IFA kit. Sera were from normal individuals of various ages, gender, and geographical areas.
Sample Size: 355 sera tested.
Results:
% Agreement positive = 81/88 = 92.1% (95% Confidence Interval = 86.3% - 97.8%)
% Agreement negative = 246/251 = 98.0% (95% Confidence Interval = 96.2% - 99.8%)
% Agreement = 327/339 = 96.5% (95% Confidence Interval = 94.5% - 98.5%)
Equivocals were not included in calculations. -
Precision: Seven sera were assayed ten times each on three different assays at two different sites, both affiliated with the manufacturer. Inter and intra assay precision were presented in Tables 2 and 3, and inter-site precision in Table 4. With appropriate technique, the user should obtain precision of 0.989 between the sites. Excluding equivocals (n = 13), four determinations varied from their expected results for a positive specimen, giving a percent agreement of expected results between the three sites of 97.1% (133/137). Expected results were derived from previous Trinity Biotech ELISA testing of samples.
Key Metrics
% Agreement positive = 81/88 = 92.1%
% Agreement negative = 246/251 = 98.0%
% Agreement = 327/339 = 96.5%
Precision: CV 0.989 between sites; percent agreement of expected results between three sites of 97.1% (133/137)
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.3120 Chlamydia serological reagents.
(a)
Identification. Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusChlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).(b)
Classification. Class I (general controls).
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NOV 26 2003
Image /page/0/Picture/1 description: The image shows a sequence of handwritten alphanumeric characters. The sequence reads 'K033079'. The characters are written in a dark ink, and the image has a slightly grainy texture.
Summary of Safety and Effectiveness Information Chlamydia 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 Chlamydia IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative detection of IgG antibodies inhuman serum to Chlamydia for the determination of immunological experience.
The Chlamydia IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Chlamydia. Purified Chlamydia antigen (strain LGV II) 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. If antibody is preset 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 Chlamydia IgG ELISA test is substantially equivalence is demonstrated by the following comparative results:
Performance Characteristics
- % Agreement Positive and % Agreement Negative. Two different sites compared the Trinity Biotech Chlamydia IgG ELISA test relative to a commercial IFA kit. The two sites were R&D laboratories at commercial companies located in Maryland and New York, and affiliated with the manufacturer of the kit. The sera were from normal individuals of various ages, gender, and geographical areas. The results of the studies are compiled and summarized in Table 1. None of the performance characteristics were established with specimens from patients having documented chlamydia infections.
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Table 1 Comparison of Chlamydia IgG ELISA and IFA
Trinity Biotech Chlamydia IgG ELISA
| + | eq | - | Total | ||
|---|---|---|---|---|---|
| + > 1:8 | 81 | 7 | 7 | 95 | |
| Chlamydia | |||||
| IFA | - 0.989 between the sites. Excluding equivocals (n = 13), four determinations varied from their expected results for a positive specimen) giving a percent agreement of expected results between the three sites of 97.1% (133/137). The expected results were derived from previous Trinity Biotech ELISA testing of the samples. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
NOV 26 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Bonnie B. DeJoy Director. Quality Systems Trinity Biotech USA P.O. Box 1059 Jamestown, NY 14702-1059
Re: K033079
Trade/Device Name: Captia Chlamydia IgG ELISA Regulation Number: 21 CFR 866.3120 Regulation Name: Chlamydia serological reagents Regulatory Class: Class I Product Code: LJC 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 (QS) 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). 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,
Steven Putman
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: K033079
Device Name: Trinity Biotech Captia™ Chlamydia IgG ELISA
Indications For Use: The Trinity Biotech Captia™ Chlamydia IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative detection of IgG antibodies in human serum to Chlamydia for the determination of immunological experience.
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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 Office of in-ond Safety
510(k) K033079