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K Number
K033083
Device Name
BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
Manufacturer
TRINITY BIOTECH USA
Date Cleared
2003-11-26

(58 days)

Product Code
LSR
Regulation Number
866.3830
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trinity Biotech Captia™ Borrelia burgdorferi IgG/IgM ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative presumptive detection of total (IgG/IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease.
Device Description
The Borrelia burgdorferi IgG/IgM ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative presumptive detection of total (IgG/IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and patients with symptoms that are consistent with Lyme disease. Equivocal or positive results should be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. The Borrelia burgdorferi IgG/IgM ELISA test is an enzyme linked immunosorbent assav to detect IgG/IgM antibodies to Borrelia burgdorferi. Purified Borrelia burgdorferi 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/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 and indirect measurement of specific antibody in the patient specimen.
More Information

Not Given

Not Found

No
The device description and performance studies detail a standard ELISA assay, which is a biochemical test, not a software-based or image processing technology that would typically incorporate AI/ML. There is no mention of AI, ML, or related terms in the document.

No
This device is an in vitro diagnostic (IVD) test used to detect antibodies for diagnostic purposes, not to treat or provide therapy for a disease.

Yes.
The device is used for the qualitative presumptive detection of antibodies to Borrelia burgdorferi in human serum to support a clinical diagnosis of Lyme disease, which directly indicates its diagnostic purpose.

No

The device is an ELISA kit, which is a laboratory assay involving physical reagents and a photometric measurement, not solely software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states it's for the "qualitative presumptive detection of total (IgG/IgM) antibodies to Borrelia burgdorferi in human serum." This involves testing a biological sample (human serum) in vitro (outside the body) to gain information about a patient's health status (exposure to Borrelia burgdorferi).
  • Device Description: The description details a laboratory test procedure (ELISA) performed on human serum to detect antibodies. This is a classic example of an in vitro diagnostic test.
  • Performance Studies: The document describes performance studies conducted on human serum samples (CDC Lyme Disease Serum Panel, fresh sera from patients). This further confirms its use in a diagnostic context.

The core function of the device is to analyze a biological sample in vitro to provide information for a clinical diagnosis, which is the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The Borrelia burgdorferi IgG/IgM ELISA kit is an Enzyme-Linked ImmunosorbentAssay (ELISA) for the qualitative presumptive detection of total (IgG/IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and patients with symptoms that are consistent with Lyme disease. Equivocal or positive results should be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease.

Product codes (comma separated list FDA assigned to the subject device)

LSR

Device Description

The Borrelia burgdorferi IgG/IgM ELISA test is an enzyme linked immunosorbent assav to detect IgG/IgM antibodies to Borrelia burgdorferi. Purified Borrelia burgdorferi 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/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 and indirect measurement of specific antibody in the patient specimen.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

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)

Performance Characteristics

The CDC Lyme Disease Serum Panel Stratified by Time After Onset

The following information is from a serum panel obtained from the CDC and tested by Trinity Biotech. The results are presented as a means to convey further information on the performance of this assay with a masked, characterized serum panel. This does not imply an endorsement of the assay by the CDC.
Table 1 Trinity Biotech B. burgdorferi IgG/IgM ELISA Results
Because the equivocals would have been tested by immunoblotting in a 2-step test system, they were considered 1-step positive for purposes of calculating % agreement. The Trinity Bitoech Borrelia burgdorferi IgG/IgM ELISA demonstrated 71% (30/42) agreement with clinical diagnosis of Lyme disease.

Study 2

One hundred seventy-six fresh sera from patients of various ages and genders that were submitted to a large clinical lab for B. burgdorferi antibody testing were tested on the Trinity Biotech B. burgdorferi IgG/IgM ELISA and BioWhittaker Lyme Stat. Any serum found positive or equivocal was tested by Mardx Diagnostics Western Blot on both IgG and IgM. The results are illustrated in Table 2.

Precision

Seven sera were assayed ten times each on three different plates at three different sites. An additional three sera were assayed ten times each on three different plates at two different sites. The intersite precision is shown in Table 3. With appropriate technique the user should obtain precision of 1yr | 8 | 0 | 0 | 8 | 100.0%
Total | 25 | 5 | 17 | 47 |

Trinity Biotech B. burgdorferi IgG/IgM ELISA demonstrated 71% (30/42) agreement with clinical diagnosis of Lyme disease.

Performance based on 1-step (ELISA) Pos. or Eq. and 2-step (WB) Pos.:

Type of Result (95%CI)Trinity (95%CI)Lyme Stat (95%CI)
1-step (ELISA) Pos. or Eq.9.1% (4.8% - 13.4%) (16/176)7.4% (3.4% - 11.3%) (13/176)
1-step Pos. or Eq. & 2-step (WB) Pos.4% (1.0% - 6.9%) (7/176)2.8% (0.3% - 5.3%) (5/176)
2-step Pos. among 65.4%)44% (18.9% - 68.6%)39% (11.5% - )
1-step Pos. or Eq.(7/16)(5/13)

Inter-Assay Precision Between Sites (CV):

Serum #XSDCVn
11.180.1139.58%90
22.260.22610.02%90
33.850.2787.21%90
45.360.4027.50%90
52.040.1869.11%90
60.330.13240.57%90
70.340.23468.93%90
81.470.15210.34%60
91.470.1047.10%60
101.650.1317.95%60
HPC5.310.3145.91%15
LPC2.700.1073.96%15
NC0.200.04321.97%15
CAL3.340.1033.08%45

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 Lyme 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.

Not Found

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).

Not Found

§ 866.3830

Treponema pallidum treponemal test reagents.(a)
Identification. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).

0

K033083

NOV 26 2003

Summary of Safety and Effectiveness Information Borrelia burgdorferi 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

burgdorferi IgG/IgM ELISA kit is an The Borrelia Enzyme-Linked ImmunosorbentAssay (ELISA) for the qualitative presumptive detection of total (IgG/IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and patients with symptoms that are consistent with Lyme disease. Equivocal or positive results should be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease.

The Borrelia burgdorferi IgG/IgM ELISA test is an enzyme linked immunosorbent assav to detect IgG/IgM antibodies to Borrelia burgdorferi. Purified Borrelia burgdorferi 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/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 and indirect measurement of specific antibody in the patient specimen.

III. Predicate Device

The Borrelia burgdorferi IgG/IgM ELISA test is substantially equivalent to BioWhittaker's Lyme STAT test. Equivalence is demonstrated by the following comparative results:

Performance Characteristics

The CDC Lyme Disease Serum Panel Stratified by Time After Onset

The following information is from a serum panel obtained from the CDC and tested by Trinity Biotech. The results are presented as a means to convey further information on the performance of this assay with a masked, characterized serum panel. This does not imply an endorsement of the assay by the CDC.

1

| Time From Onset | positive | equivocal | negative | Total | % Agreement
with Clinical
Diagnosis |
|-----------------|----------|-----------|----------|-------|-------------------------------------------|
| normals | 0 | 0 | 5 | 5 | 100% |
| 1yr | 8 | 0 | 0 | 8 | 100.0% |
| Total | 25 | 5 | 17 | 47 | |

Table 1 Trinity Biotech B. burgdorferi IgG/IgM ELISA Results

Because the equivocals would have been tested by immunoblotting in a 2-step test system, they were considered 1-step positive for purposes of calculating % agreement. The Trinity Bitoech Borrelia burgdorferi IgG/IgM ELISA demonstrated 71% (30/42) agreement with clinical diagnosis of Lyme disease.

Study 2

One hundred seventy-six fresh sera from patients of various ages and genders that were submitted to a large clinical lab for B. burgdorferi antibody testing were tested on the Trinity Biotech B. burgdorferi IgG/IgM ELISA and BioWhittaker Lyme Stat. Any serum found positive or equivocal was tested by Mardx Diagnostics Western Blot on both IgG and IgM. The results are illustrated in Table 2.

Table 2

Western-blot

| Trinity

B. burgdorferi IgG/IgM+6-3
eq16
Lyme Stat+5-3
eq05
Type of Result (95%CI)Trinity (95%CI)Lyme Stat (95%CI)
1-step (ELISA) Pos. or Eq.9.1% (4.8% - 13.4%)
(16/176)7.4% (3.4% - 11.3%)
(13/176)
1-step Pos. or Eq. &
2-step (WB) Pos.4% (1.0% - 6.9%)
(7/176)2.8% (0.3% - 5.3%)
(5/176)
2-step Pos. among
65.4%)44% (18.9% - 68.6%)39% (11.5% - )
1-step Pos. or Eq.(7/16)(5/13)

CI = Confidence Interval

2

Precision

Seven sera were assayed ten times each on three different plates at three different sites. An additional three sera were assayed ten times each on three different plates at two different sites. The intersite precision is shown in Table 3. With appropriate technique the user should obtain precision of Trade/Device Name: Captia Borrelia burgdorferi IgG/IgM ELISA Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: Class II Product Code: LSR 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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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,

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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Page 1 of 1

Over-The-Counter Use

510(k) Number: K033083

Device Name: Trinity Biotech Captia™ Borrelia burgdorferi IgG/IgM ELISA

Indications For Use: The Trinity Biotech Captia™ Borrelia burgdorferi IgG/IgM ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative presumptive detection of total (IgG/IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease.

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANQTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 XFR 801.109) OR

(Optional Format 1-2-96)

Division Sign-Off for fMP

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K033083