(238 days)
IFA
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No
The device description and performance studies detail a standard ELISA assay, which relies on chemical reactions and photometric measurement, not AI/ML algorithms for analysis or interpretation. There are no mentions of AI, ML, or related concepts.
No.
This device is an in-vitro diagnostic (IVD) test kit used for the qualitative detection of Chlamydia IgG antibodies, which is an ancillary diagnostic tool and does not treat or alleviate a disease or condition.
Yes
The device is described as an "Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative detection of IgG antibodies in human serum to Chlamydia for the determination of immunological experience," which directly indicates its use for diagnosing past exposure to Chlamydia. The "Intended Use / Indications for Use" section and the detailed "Device Description" confirm its purpose is to detect specific markers (antibodies) in a patient's sample to infer a medical condition or experience.
No
The device is a laboratory assay kit involving physical reagents, microtiter wells, and photometric measurement, clearly indicating it is a hardware-based medical device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "qualitative detection of IgG antibodies in human serum to Chlamydia for the determination of immunological experience." 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 experience with Chlamydia).
- Device Description: The description details a laboratory test (ELISA) performed on a human specimen (diluted test sera) using reagents and a specific procedure to detect the presence of antibodies. This is a classic description of an in vitro diagnostic test.
- Performance Studies: The performance studies describe testing the device with human serum samples and comparing the results to other diagnostic methods (IFA, CF). This further confirms its use in a diagnostic context.
The definition of an In Vitro Diagnostic device generally includes instruments, reagents, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device fits that definition by detecting antibodies in a human sample to assess immunological experience related to Chlamydia, which is relevant to diagnosing or understanding past exposure to the infection.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Relative sensitivity and specificity: Two different sites compared the Wampole 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 manufacturing of the kit. The sera were from normal individuals of various ages, gender, and geographical areas. The total sample size was 355.
Relative Sensitivity = 81/88 = 92.1% (95% Confidence interval = 86.3% - 97.8%)
Relative Specificity = 246/251 = 98.0% (95% Confidence interval = 96.2% - 99.8%)
Relative Agreement = 327/339 = 96.5% (95% Confidence interval = 94.5% - 98.5%)
Equivocals were not included in the above calculations. -
Precision: Seven sera were assayed ten times each on three different assays at two different sites. Both sites were affiliated with the manufacturing of the kit.
Intra and Inter Assay Precision Study 1 (Assay n=30 per sera, Inter Assay n=30 per sera)
Intra and Inter Assay Precision Study 2 (Assay n=10 per sera, Inter-Assay(n=30) per sera)
Inter Site Precision Study (n=60 per sera)
The results show varying CVs for different sera and assays, generally below 15% CV with appropriate technique. -
CF Paired Serum Analysis: Nine serum pairs showing a greater than 4 fold increase in CF titer or seroconversions by CF were assayed on the Chlamydia IgG ELISA assay.
Sensitivity in demonstrating a seroconversion by ELISA when CF showed a 4-fold increase or seroconversion: 44% (4/9). -
Reproducibility Study: Fifty different sera with various levels of activity were assayed at three different sites. Two sites were R&D laboratories at commercial companies located in Maryland and New York. The third site was a large clinical laboratory located in Pennsylvania.
The data from the three sites show good correlation with ISR values with product moment correlation coefficients of >0.989 between the sites.
Excluding equivocals (n = 13), four determinations varied from its expected result (negative results for a positive specimen).
%agreement of expected results between the three sites of 97.1% (133/137). The expected results were derived from previous Wampole ELISA testing of the samples.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative Sensitivity = 81/88 = 92.1%
Relative Specificity = 246/251 = 98.0%
Relative Agreement = 327/339 = 96.5%
Sensitivity in demonstrating a seroconversion (compared to CF): 44% (4/9)
%agreement of expected results between the three sites (reproducibility): 97.1% (133/137)
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.
IFA
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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§ 866.3120 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).
0
Summary of Safety and Effectiveness Information Chlamydia IgG ELISA Test Kit
FEB 2 4 1997
I. Immuno Probe Inc. 1306 Bailes Lane, Suite F Frederick, Maryland 21701 Contact person: William Boteler Telephone: 301-695-7920 Date of preparation: Jan 13, 1996
II. Description of Device
The 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.
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 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 Chlamydia IgG ELISA test is substantially equivalent to IFA. Equivalence is demonstrated by the following comparative results:
1
Performance Characteristics
- Relative sensitivity and specificity. Two different sites compared the Wampole 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 manufacturing 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.
Table 1 Comparison of Chiamydia IgG ELISA and IFA
| + | eq | - | Total | ||
|---|---|---|---|---|---|
| + >1:8 | 81 | 7 | 7 | 95 | |
| Chlamydia | |||||
| IFA | - 0.989 between the sites. Excluding equivocals (n = 13) four determinations varied from its expected result (negative results for a positive specimen) giving a %agreement of expected results between the three sites of 97.1% (133/137). The expected results were derived from previous Wampole ELISA testing of the samples. |