(58 days)
BioWhittaker's Legionella STAT test.
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No
The device description and performance studies focus on standard ELISA methodology and statistical analysis of agreement and precision, with no mention of AI or ML.
No.
This device is an in vitro diagnostic (IVD) test designed to detect antibodies to Legionella pneumophila, which aids in the diagnosis of Legionella Disease. It does not directly provide therapy or treatment to a patient.
Yes
The device is described as an "ELISA kit for the qualitative detection of total antibodies (IgG and IgM) to serogroups 1-6 in serum from patients with clinical suspicion of Legionella Disease." This directly indicates its use in identifying markers related to a disease state, which is a diagnostic purpose.
No
The device description clearly outlines a physical ELISA kit involving reagents, microtiter wells, and photometric measurement, 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 it's for the "qualitative detection of total antibodies (IgG and IgM) to serogroups 1-6 in serum from patients with clinical suspicion of Legionella Disease." This indicates it's used to test human specimens (serum) to provide information about a patient's health status (presence of antibodies related to Legionella Disease).
- Device Description: The description details a laboratory test (ELISA) that analyzes a biological sample (serum) to detect specific analytes (antibodies to Legionella pneumophila).
- Performance Studies: The inclusion of performance studies comparing the device to other methods (IFA) and reporting metrics like % Agreement and precision further supports its classification as a diagnostic test.
These characteristics 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 Trinity Biotech Captia™ Legionella pneumophila IgG/IgM ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection of total antibodies (IgG and IgM) to serogroups 1-6 in serum from patients with clinical suspicion of Legionella Disease. The assay is not intended to differentiate between the serotypes of Legionella pneumophila.
Product codes (comma separated list FDA assigned to the subject device)
MJH
Device Description
The Legionella pneumophila IgG/IgM ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection of total antibodies (IgG and IgM) to Legionella pneumophila serogroups 1-6 in serum from patients with clinical suspicion of Legionella Disease.
The Legionella pneumophila IgG/IgM ELISA test is an enzyme linked immunosorbent assay to detect IgG/IgM antibodies to legionella. Purified Legionella pneumophila antigen (serogroups 1, 2, 3, 4, 5, 6) 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/IgM 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
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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
Site 1: Thirty-three single IFA positive sera, from an outbreak and samples routinely submitted for Legionella testing.
Site 2: Seventy-two prospective serum for Legionella testing.
CDC Panel: Thirty-one serum pairs showing a greater than 4-fold increase in IFA titer. Sera submitted to CDC for titer confirmation.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Characteristics: % Agreement Positive and % Agreement Negative (comparative study against Legionella IFA).
Site 1: 33 samples. % Agreement positive = 27/30 = 90.00% (95% Confidence interval = 79.0% - 100%).
Site 2: 72 samples. % Agreement positive = 67/68 = 98.53% (95% Confidence Interval = 95.6% - 100%). % Agreement negative = 69/70 = 98.57% (95% Confidence Interval = 95.7% - 100%).
Precision: Intra- and Inter-Assay Precision (repeated testing of sera).
Study 1: Seven different sera tested 10 times each on 3 different days. An additional three sera tested at site 1.
Study 2: Seven different sera tested 10 times each on 3 different days.
Inter-Site Precision Study: Seven sera tested across two different sites, n=60 for each serum.
IFA Paired Serum Analysis (CDC Panel): 31 serum pairs. % agreement positive of 29/31 = 93.5% in detecting seroconversions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
% Agreement positive = 90.00% (Site 1)
% Agreement negative = NA (Site 1)
% Agreement positive = 98.53% (Site 2)
% Agreement negative = 98.57% (Site 2)
Precision: Reported as Coefficient of Variation (CV) for intra-assay, inter-assay, and inter-site.
% agreement positive in detecting seroconversions = 93.5% (CDC Panel)
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.
BioWhittaker's Legionella STAT test.
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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§ 866.3300
Haemophilus spp. serological reagents.(a)
Identification. Haemophilus spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye, that are used in serological tests to identifyHaemophilus spp. directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusHaemophilus and provides epidemiological information on diseases cause by these microorganisms. Diseases most often caused byHaemophilus spp. include pneumonia, pharyngitis, sinusitis, vaginitis, chancroid venereal disease, and a contagious form of conjunctivitis (inflammation of eyelid membranes).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
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NOV 2 6 2003
K033a51
Summary of Safety and Effectiveness Information Legionella pneumophila IgG/IgM 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 Legionella pneumophila IgG/IgM ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection of total antibodies (IgG and IgM) to Legionella pneumophila serogroups 1-6 in serum from patients with clinical suspicion of Legionella Disease.
The Legionella pneumophila IgG/IgM ELISA test is an enzyme linked immunosorbent assay to detect IgG/IgM antibodies to legionella. Purified Legionella pneumophila antigen (serogroups 1, 2, 3, 4, 5, 6) 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/IgM 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 Legionella pneumonphila IgG/IgM ELISA test is substantially equivalent to BioWhittaker's Legionella STAT test. Equivalence is demonstrated by the following comparative results:
Performance Characteristics
% Agreement Positive and % Agreement Negative
The Trinity Biotech Legionella pneumophila IgG/IgM ELISA was evaluated relative to Legionella IFA at two different sites. The first site was a commercial R&D lab located in Marvland. Thirty-three single IFA positive sera, from an outbreak and samples routinely submitted for Legionella testing, were tested. The results of the study are summarized in Table 3.
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Table 3 Comparison of Trinity Biotech Legionella pneumophila IgG/IgM ELISA and Legionella IFA Trinity Biotech Legionella pneumophila IgG/IgM ELISA
| + | eq | - | Total | |
|---|---|---|---|---|
| + ≥ 256 | 27 | 3 | 3 | 33 |
| IFA - 1:256. The sera were submitted to CDC for titer confirmation. The results are presented as a means to convey further information on the performance of this assay with a masked serum panel. This does not imply an endorsement of the assay by the CDC. |
The panel consisted of thirty-one serum pairs showing a greater than 4-fold increase in IFA titer. Each serum pair was evaluated on the Trinity Biotech Legionella pneumophila IgG/IgM ELISA assay to determine a seroconversion in antibody. Twenty nine pairs had a seroconversion, thus giving a % agreement positive of 29/31 = 93.5% in detecting seroconversions.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine and healthcare.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 26 2003
Ms. Bonnie B. DeJoy Director, Quality Systems Trinity Biotech USA P.O. Box 1059 Jamestown, NY 14702-1059
Re: K033051
Trade/Device Name: Legionella pneumophila IgG/IgM ELISA Regulation Number: 21 CFR 866.3300 Regulation Name: Haemophilus spp. serological reagents Regulatory Class: Class II Product Code: MJH 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. Iisting 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 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: K033051
Device Name: Trinity Biotech Captia™ Legionella pneumophila IgG/IgM ELISA
Indications For Use: The Trinity Biotech Captia™ Legionella pneumophila IgG/IgM ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection of total antibodies (IgG and IgM) to serogroups 1-6 in serum from patients with clinical suspicion of Legionella Disease. The assay is not intended to differentiate between the serotypes of Legionella pneumophila.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 XFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Thomas J. O'Brien for SYH
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K033051