WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254
Device Facts
| Record ID | K023889 |
|---|---|
| Device Name | WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254 |
| Applicant | Wiener Laboratories Saic |
| Product Code | MIU · Microbiology |
| Decision Date | Feb 11, 2004 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3870 |
| Device Class | Class 1 |
| Attributes | Pediatric |
Indications for Use
The Wiener Laboratory enzyme-linked Immunosorbent assay (ELISA) recombinante V. 3.0 test (using the Biochem Immunosystems, Inc Labotech System instrument) is a manual and automated qualitative detection of total antibodies (IgG and IgM) to Trypanosoma cruzi in human serum and plasma (EDTA, heparin, or Citrate) using recombinant antigens of T. cruzi. Results are presumptive evidence of present or past infection with Trypanosoma cruzi.
Device Story
Chagatest ELISA rec. v.3.0 is an in vitro diagnostic ELISA for detecting antibodies to Trypanosoma cruzi; causative agent of Chagas' disease. Input: human serum or plasma samples. Principle: recombinant T. cruzi antigens (epimastigote/trypomastigote stages) immobilized on microplate wells; patient antibodies bind to antigens; peroxidase-conjugated anti-human immunoglobulin added; chromogenic substrate (TMB) produces reaction measured by standard ELISA plate reader at 450 nm. Used in clinical laboratories; operated by trained technicians. Output: qualitative result (reactive/non-reactive) based on absorbance compared to cutoff. Assists clinicians in diagnosing Chagas' disease and identifying prior exposure. Benefits patients by enabling identification of infection, particularly relevant for acute trypanosomiasis in children and blood donor screening.
Clinical Evidence
Clinical performance evaluated across multiple studies (N=1839 total specimens) comparing subject device to predicate ELISAs and reference methods (IHA, IFA, RIPA). Overall relative sensitivity 97.9% (95% CI: 95.6-99.1%) and relative specificity 97.8% (95% CI: 97.0-98.5%). Studies included diverse populations (low-risk, endemic areas, blood donors, pregnant women). Precision studies (intra-assay and inter-assay) performed using both manual and automated (Labotech) methods, showing acceptable reproducibility.
Technological Characteristics
ELISA-based serological assay. Recombinant T. cruzi antigens immobilized on microplate wells. POD-labeled conjugate; TMB substrate; sulfuric acid stop solution. Read at 450 nm. Compatible with manual or automated (Labotech) processing. Sample types: serum, heparinized/EDTA/citrated plasma. Software: automated analysis via Labotech system.
Indications for Use
Indicated for qualitative detection of total antibodies (IgG and IgM) to Trypanosoma cruzi in human serum and plasma to aid in the diagnosis of Chagas' disease and establish prior exposure to T. cruzi.
Regulatory Classification
Identification
Trypanosoma spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Trypanosoma spp. in serum. The identification aids in the diagnosis of trypanosomiasis, a disease caused by parasitic protozoans belonging to the genus Trypanosoma. Trypanosomiasis in adults is a chronic disease characterized by fever, chills, headache, and vomiting. Central nervous system involvement produces typical sleeping sickness syndrome: physical exhaustion, inability to eat, tissue wasting, and eventual death. Chagas disease, an acute form of trypanosomiasis in children, most seriously affects the central nervous system and heart muscle.
Predicate Devices
- MERIDIAN Premier Chagas' IgG ELISA
- ABBOTT Chagas Antibody EIA
Reference Devices
- Wiener lab Indirect Hemagglutination Assay (IHA)
- Immunofluorescence assay (IFA)
- Radio Immuno Precipitation Assay (RIPA)
- Polychaco Indirect Hemagglutination Assay (IHA)
Related Devices
- K161947 — Chagas Detect Plus Rapid Test · InBios International, Inc. · Dec 16, 2016
- K072732 — ORTHO T. CRUZI ELISA TEST SYSTEM · Ortho-Clinical Diagnostics, Inc. · Apr 15, 2009
- K963296 — INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565) · Incstar Corp. · Dec 16, 1996
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/2 description: The image is a circular seal with the text "Wiener lab. SISTEMA DE CALIDAD CERTIFICADO" around the edge. In the center of the seal, there is the text "ISO 9001" above a logo that appears to be "TUV". The seal is black and white and appears to be a stamp.
Image /page/0/Picture/3 description: The image shows the logo for Wiener lab. The logo consists of a stylized letter W inside of a circle on the left, and the text "Wiener lab." on the right. Below the text is the phrase "Especialidades para Laboratorios Clinicos".
**WIENER LABORATORIOS S.A.I.C.** - Riobamba 2944 - 2000 Rosario - Argentina
Phone +54 (341) 432-9191/6 - Fax +54 (341) 432-5454/5555
Internet: <http://www.wiener-lab.com.ar>
Section 6 – Summary
### 510(k) Summary "This summary of 510(k) safety and effectiveness information is being
"This summary of 510(k) safety and effectiveness informants hary of OTO(R) ourordance with the requirements of SMDA 1990 and 21CFR 807.92"
"The assigned 510(k) number is: _____________________________________________________________________________________________________________________________________________
| Introduction | According to the requirements of 21 CFR 866.3870, the following information provides sufficient details to understand the basis of a determination of substantial equivalence. |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6-1 Submitter Name, Address, Contact | Wiener Laboratorios S.A.I.C.<br>Riobamba 2944<br>2000 - Rosario - Argentina<br>Contact person: Viviana Cétola<br>Date Prepared: November 5, 2002 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| 6-2 Device Name | |
|----------------------|-----------------------------------------------------|
| Proprietary name: | Chagatest ELISA recombinante v.3.0 |
| Common name: | Trypanosoma cruzi serological reagent. |
| Classification name: | Enzyme linked Immunosorbent assay Trypanosoma cruzi |
| Device Class | I |
{1}------------------------------------------------
We claim substantial equivalence to the currently marketed 6-3 Predicate WE Claim Cabblankia' IgG ELISA and ABBOTT Chagas Device Antibody EIA test systems. In this qualitative technique for the detection of antibodies anti-6-4 Device In this qualitat. The sample is diluted in the wells in which Description 1. Cruzi, the campio re immobilized. These antigens are recombinant antigens artisting es starting from specific proteins from the epimastigote and trypomastigote stages of the T. cruzi corresponding to highly conserved zones stages of the 7. State sen streep are proteins with aminoacid among annoront one in tandem. SAPA (shed acute phase sequences Topoutou in tath 93% of the patients' sera during antigen) antigense of the infection. It comes from the the addite prider of parasite; #1, #2 and #30 antigens trypomastigoto-blags in chronic patients; #13 and #36 specially dotest antibodies in sera both from acute and chronic patients. pationis.
If the sample contains Chagas' antibodies, they bind to the If the sumplo contains ound to the support. The unbound antigens and Tomain boo washing, after which anti-human immunoglobulin antibodies conjugated to peroxidase are mimanoglobalin annia was produced in the first step of the added. If a readjugate is bound. After a new washing step process, the conjugua chromogenic substrate and stopping and the adultions containing antibodies to T. cruzi produce reagent, opsoimeneaction which can be read with a standard ELISA plate reader. The Wiener lab. Chagatest ELISA recombinante v.3.0 test 6-5 Intended Use
system is an in vitro diagnostic system intended to be used in the qualitative detection of antibodies to Trypanosoma cruzi, the causative agent of Chagas' disease in human serum and the causalive ugent according to instructions, the kit is useful in establishing prior exposure to T. Cruzi and as an aid in the diagnosis of Chagas' disease.
Chagas' disease, an acute form of trypanosomiasis in children, most seriously affects the central nervous system and heart muscle.
{2}------------------------------------------------
## 6-6 Equivalencies and differences
The WIENER LAB. Chagatest ELISA recombinante v.3.0 test system is substantially The WENER LAB. Chagatest ELIOA Tecomminte on intended for similar use. Most
equivalent to other products in commercial distribution interest MERICAN Promier" equivalent to biner products in Commercial natures narketed MERIDIAN Premier™
notably it is substantially equivalent to the currently marketed MERIDIAN Premier™ nolably it is "substantially" equiridian" is "antibody ElA test systems.
> The following table illustrates the similarities and differences between the The Tollowing table Indistrates the children is 3.0 test system and the WIENEN LAB: Onagatos: ELICA Freas' IgG ELISA test system.
| | MERIDIAN<br>Test System | WIENER LAB. Test<br>System |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Qualitative detection of<br>antibody to Trypanosoma<br>cruzi, the causative<br>agent for Chagas'<br>disease in human serum. | Qualitative detection of<br>antibody to Trypanosoma<br>cruzi, the causative<br>agent for Chagas'<br>disease in human serum<br>or plasma. |
| Test principle | ELISA test employing<br>purified T. cruzi antigens<br>bound to ELISA plate<br>wells, ALP-labeled<br>conjugate, pNPP as<br>substrate and NaOH as<br>stopping solution. | ELISA test employing<br>recombinant T. cruzi<br>antigens bound to ELISA<br>plate wells, POD-labeled<br>conjugate, TMB as<br>substrate and sulfuric<br>acid as stopping solution. |
| Essential<br>Components | Purified T. cruzi antigens | Recombinant T. cruzi<br>antigens |
| Sample | Human serum. | Human serum and<br>plasma (heparinized,<br>EDTA, citrated) |
| Wavelength of<br>reading. | 405 nm | 450 nm |
{3}------------------------------------------------
The following table illustrates the similarities and differences between The WIENER LAB. Chagatest ELISA recombinante v.3.0 test system the WIENER EAB Onagatest ABBOTT Chagas Antibody EIA test system.
| | ABBOTT<br>Test System | WIENER LAB. Test<br>System |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Qualitative detection of<br>antibody to<br>Trypanosoma cruzi, the<br>causative agent for<br>Chagas' disease in<br>human serum or<br>plasma. | Qualitative detection of<br>antibody to Trypanosoma<br>cruzi, the causative agent<br>for Chagas' disease in<br>human serum or plasma. |
| Test principle | ELISA test employing<br>purified T. cruzi antigens<br>bound to beads, POD-<br>labeled conjugate, OPD<br>as substrate and sulfuric<br>acid as stopping<br>solution. | ELISA test employing<br>recombinant T. cruzi<br>antigens bound to ELISA<br>plate wells, POD-labeled<br>conjugate, TMB as<br>substrate and sulfuric<br>acid as stopping solution. |
| Essential<br>Components | Purified T. cruzi<br>antigens | Recombinant T. cruzi<br>antigens |
| Sample | Human serum and<br>plasma (EDTA,<br>potassium oxalate,<br>heparin and citrate<br>based anticoagulants). | Human serum and<br>plasma (heparin, EDTA<br>and citrate based<br>anticoagulants) |
| Wavelength of<br>reading. | 492 nm | 450 nm |
Equivalence is demonstrated by the following comparative results:
### PERFORMANCE CHARACTERISTICS
1. Studies and comparison
### 1.1 Comparison of WIENER LAB and MERIDIAN Chagas kits.
In a study, 300 serum and 200 plasma specimens from random U.S. low-risk individuals, in a Study, 000 Scram and 200 Wiener lab Chagatest ELISA rec. v.3.0. and the Premier from fowa, were evaluation Diag.). Any of these specimens (0%) was reactive for antibodies to T. cruzi.
{4}------------------------------------------------
| | Premier Chagas' IgG ELISA (Meridian Diag.) | | |
|-----------------------------------------|--------------------------------------------|--------------|--------------------|
| Wiener lab Chagatest<br>ELISA rec v.3.0 | Reactive | Non-reactive | Discordant results |
| | 0 | 500 | 0 |
1.2 Comparison of WIENER LAB and MERIDIAN Chagas kits.
1.2 Ooklpanson of theremens was tested from a Mexican Blood Bank (Guadalajara and A population of 60 SposilViener lab Chagatest ELISA rec. v.3.0 and Premier Chagas' IgG ELISA (Meridian Diag.).
Certain specimens were also tested by RIPA (Radio Immuno Precipitation Assay). The following results were obtained:
| | Premier Chagas' IgG ELISA (Meridian Diag.) | | |
|-----------------------------------------|--------------------------------------------|--------------|--------------------|
| Wiener lab Chagatest<br>ELISA rec v.3.0 | Reactive | Non-reactive | Discordant results |
| | 9 | 69 | 5a |
Out of 5 specimens with discordant results, all 5 were reactive by Wiener lab ELISA and a RIPA, but non-reactive by Meridian.
### 1.3 Comparison of WIENER LAB and ABBOTT Chagas kits.
1.5 Ooklpansof of Villand from Argentina (Rosario, SF, Argentina) was tested in A population of 100 chagatest ELISA rec. v.3.0 and Abbott Chagas Antibody ElA. puration betwoon were also tested by Wiener lab Indirect Hemagglutination Assay (IHA) and an in-house Immunofluorescence assay (IFA).
The following results were obtained:
| | Abbott Chagas Antibody ElA | | |
|-----------------------------------------|----------------------------|--------------|--------------------|
| Wiener lab Chagatest<br>ELISA rec v.3.0 | Reactive | Non-reactive | Discordant results |
| | 226 | 552 | 12 |
Of the 12 specimens with discordant results: a
6 specimens were reactive by Wiener lab Chagatest ELISA rec.v.3.0 and non-reactive by Abbott Chagas Antibody EIA. Out of those 6 specimens, 3 were reactive by IFA.
- 6 specimens were non reactive by Wiener lab Chagatest ELISA rec.v.3.0 and reactive by Abbott Chagas Antibody EIA. Out of those 6 specimens, 1 was reactive by IFA and IHA.
1.4 Comparison of WIENER LAB and ABBOTT Chagas kits.
A population of 286 specimens was tested in Buenos Aires (Hospital de Clínicas, Buenos Aires, Argentina) by Wiener lab Chagatest ELISA rec. v.3.0, Polychaco Indirect Hemagglutination Assay(IHA) and Abbott Chagas Antibody EIA. The following results were obtained:
{5}------------------------------------------------
| | Abbott Chagas Antibody EIA | | |
|-----------------------------------------|----------------------------|--------------|--------------------|
| Wiener lab Chagatest<br>ELISA rec v.3.0 | Reactive | Non-reactive | Discordant results |
| | 0 | 285 | 1a |
Reactive by Wiener lab Chagatest ELISA rec. v.3.0 and non-reactive by Abbott Chagas ನ Antibody EIA and IHA.
1.5 Comparison of WIENER LAB, with ABBOTT and MERIDIAN Chagas kits
1.5 Collipanson of VVLNEN DND, With ADD Min -reactive for the presence of Anti- T.Cruzi A pariel of Sela Typined as Teactive and Tierrosination Assay (IHA), an in-house Immunofluorescence assay (IFA) and/or RIPA, it was also tested by the following 3 ELISA (Maridion ifrimundolescence assay (if // androi Android Android Chagas' IgG ELISA (Meridian Diag.) and Abbott Chagas Antibody EIA.
#### The following results were obtained:
1 5a. Comparison Wiener lab vs Abbott ELISA kits
| | Abbott Chagas Antibody EIA | | |
|-----------------------------------------|----------------------------|--------------|--------------------|
| | Reactive | Non-reactive | Discordant results |
| Wiener lab Chagatest<br>ELISA rec v.3.0 | 47 | 33 | 10a |
- Out of 10 specimens with discordant results: a
- Out of 10 specimens with discordant rount.
7 specimens were reactive by Wiener lab ELISA, reactive by IHA / IFA / RIPA and/or -Meridian ELISA and non-reactive by Abbott ELISA
- Mendian ELISA and non-reactive by Kiener lab ELISA and Meridian ELISA, but reactive । 2 Specimens were non rousine by other by other two specimens are equivocals for Wiener lab's ELISA kit.
- Wiener lab s LLOA Kit.
1 specimen was non-reactive by Wiener lab ELISA, non-reactive by all other methods but reactive by Abbott ELISA.
### 1,5b. Comparison Wiener lab vs Meridian ELISA kits
| | Premier Chagas' IgG ELISA (Meridian Diag.) | | |
|-----------------------------------------|--------------------------------------------|--------------|--------------------|
| | Reactive | Non-reactive | Discordant results |
| Wiener lab Chagatest<br>ELISA rec v.3.0 | 41 | 36 | 13b |
Of the 13 specimens with discordant results, all were reactive by Wiener lab. ELISA, b reactive by IHA / IFA / RIPA and/or Abbott ELISA, but non-reactive by Meridian ELISA.
#### Data summary
#### Relative sensitivity
I Crative Schildry Osing the allemative mountals, besctive, 2 were equivocal and 7 were non-reactive using the Wiener lab Chagatest ELISA rec. v.3.0. The relative sensitivity was 97.9%.
{6}------------------------------------------------
### Relative Specificity
Relative Specificity
Using the alternative methods, 1507 specimens tested non-reactive using the Using the alternative methods, 1307 Specifican toological mon-reactive using the antibodies. Of these specimens, "52 were roustrol and 1988.
Wiener lab Chagatest ELISA rec. v. 3.0. The relative specificity was 97.8%.
### Relative agreement
Relative agreement
Using the above results, the relative agreement was 97.9%
Note: samples giving equivocal results were not included in the calculation of relative Note: samples gring our relative agreement.
## Relative Sensitivity, Specificity and Agreement before resolution of discordant samnies
| samples.<br>Site | N | Relative<br>Sensitivity (%) | Relative<br>Specificity (%) | Relative<br>Agreement (%) |
|------------------|------|-----------------------------|-----------------------------|---------------------------|
| 1 | 500 | N/A | 100.0 (500/500) | 100.0 (500/500) |
| 2 | 83 | 100.0 (9/9) | 93.2 (69/74) | 94.9 (78/83) |
| 3 | 790 | 97.4 (226/232) | 98.9 (552/558) | 98.5 (778/790) |
| 4 | 286 | N/A | 99.7 (285/286) | 99.7 (285/286) |
| 5a | 90 | 97.5 (47/48) | 82.5 (33/40) | 90.9 (80/88) |
| 5b | 90 | 100.0 (41/41) | 73.5 (36/49) | 85.5 (77/90) |
| Total | 1839 | 97.9 (323/330) | 97.8 (1475/1707) | 97.9 (1798/1837) |
Relative refers to a direct comparison of Wiener lab Chagatest ELISA rec. v. 3.0 results to Relative refers to a direct companson of victire lab correlate with disease presence of that of a similar test. No attempt has been made to convision in the predicate assay's accuracy to predict Chagas' disease.
| | | Predicate Chagas' EIA kits | | | |
|-------------------------------------------------|--------------|----------------------------|-----------|--------------|-------------|
| | | Reactive | Equivocal | Non-Reactive | Total |
| Wiener lab<br>Chagatest<br>ELISA rec. v.<br>3.0 | Reactive | 323 | - | 32 | 355 |
| | Equivocal | 2 | - | - | 2 |
| | Non-Reactive | 7 | - | 1475 | 1482 |
| | Total | 332 (330) | - | 1507 | 1839 (1837) |
Relative Sensitivity = 97.9% (323/330), 95% Cr (Confidence Interval)= 95.6 = 99.1% Relative Sensitivity = 37.8% (1475/1507), 95% Cl = 97.0 - 98.5%)
Relative Specificity = 97.8% (1475/1507), 95% Cl = 97.0 - 98.5% Relative Specificity - 07.9% (1798/1837), 95% Cl = 97.1 - 98.5%
*95% Confidence Intervals (CI) calculated by the Exact Method.
### 2. Specificity and Sensitivity
At present, there is no recognized standard method for establishing the presence of At present, there is no recognized other more includes to testing serum and antibodies to 7. cruzi in numan blood. Relative opeoment geographical regions of the American continent.
Sensitivity for T. cruzi antibodies was calculated based on testing of xenodiagnosed Sensitivity for 1. crazi antibodies was calculated data assay (IHA), Indirect
{7}------------------------------------------------
Immunofluorescence Assay (IFA) and/or Enzyme-linked Immunosorbent Assay (ELISA) reactive specimens.
The performed studies show that:
- 2.1 Relative specificity based on an assumed zero prevalence of antibody to T. cruzi in Relative specimenty based on an accument (Clinical Laboratories of lowards) of lowards Hospitals, lowa City, USA) is estimated to be 100% (500/500) with a 95.0% Confidence Interval (CI) of 99.2 - 100.0%.
- 2.2 Relative sensitivity of the Wiener lab. Chagatest ELISA rec.v.3.0 in a selected Relative Johns reactive specimens (previously selected as reactive by IHA, population of 110 Onages road.ro op from 1 month to 84 years old) from an endemic IFA and/or ELIOA and Tanging In Eganss y Patología Regional, Santiago del Estero, area (Ochto de Enformisdad as 31% (117/118) with a 95.0% Confidence Interval of 95.3 -- 99.98%.
| | IHA / IFA / ELISA | | |
|------------------------------------------------|-------------------|--------------|-------|
| Wiener lab<br>Chagatest<br>ELISA rec.<br>v.3.0 | REACTIVE | Non-Reactive | TOTAL |
| REACTIVE | 117 | 0 | 117 |
| Non-Reactive | 1 | 0 | 1 |
| TOTAL | 118 | 0 | 118 |
- 2.3 Relative sensitivity of the Wiener lab. Chagatest ELISA rec.v.3.0 in 2 selected Relative Scholly of the Wenchive specimens from Chile (Instituto de Ciencias populations of ST Onagas Touch) Voisersidad de Chile, Santiago de Chile, Chile) is Diomedical, Fucultud do Mouteirta, Criver Confidence Interval of 93.0 - 100.0 %.
| Group1: 25 sera from patients<br>with confirmed Chagas' disease<br>by xenodiagnosis, IHA and IFA. | Wiener lab Chagatest ELISA rec. v.3.0<br>Reactive Results<br>25<br>Sensitivity: 100% |
|------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Group 2: 26 sera from blood<br>donors, with at least 2 reactive<br>results of serological tests for<br>Chagas' disease | Reactive Results<br>26 |
- 2.4 In an evaluation performed by the ISP (Instituto de Salud Pública, Santiago de Chile, In an evaluation performent previously tested by IFA and ELISA, were assayed by Wiener Onlic), 100 spoolinens provide of the sensitivity of 100% (65/65) with a 95.0% Confidence Interval of 94.5 - 100.0% and a specificity of 98.8% (84/85) with a 95.0% Confidence Interval of 93.62 -- 99.97%.
| | IFA /ELISA | | | |
|---------------------------------------------|--------------|----------|--------------|-------|
| Wiener lab<br>Chagatest ELISA<br>rec. v.3.0 | REACTIVE | REACTIVE | Non-Reactive | TOTAL |
| | REACTIVE | 65 | 1 | 66 |
| | Non-Reactive | 0 | 84 | 84 |
| | TOTAL | 65 | 85 | 150 |
Patient with an autoimmune disease.
{8}------------------------------------------------
- 2.5 In a population of high prevalence of Chagas' disease (San Carlos, Provincial de Salta, Argentina), 58 blood bank specimens were studied, analyzed in parallel between Algentifa), 50 blood bank Specimens word an include Indirect Hemagglutination Viener Tab Criagatest ELEA 100. tv 100% (8/8) and a specificity of 98% (49/50) Assay(ITA). It is obtained a sonstitutif of 89.95%. The individual -reactive with With a 95.0% Connique interval or 80.58 - on-reactive for IHA - presented an Wierel Tab Chagatest EEFOR TOU: For and Territic sign of acute phase from Thagas' disease. Three weeks later, when a new specimen was drawn, the sample Chagas disease. Thise weeks later, when a lowen this individual is removed from showed reachvily for ight in A and Torin ( tooks with a 95.0% Confidence Interval of 92.75 - 100.0%. (Prevalence (9/58): 15.5%).
| | IHA | | | |
|---------------------------------------------|-----|----------|--------------|-------|
| Wiener lab<br>Chagatest ELISA<br>rec. v.3.0 | | REACTIVE | Non-Reactive | TOTAL |
| REACTIVE | | 8 | 1 | 9 |
| Non-Reactive | | 0 | 49 | 49 |
| TOTAL | | 8 | 50 | 58 |
Acute case
From the same geographic region (Salta, Argentina) 52 specimens previously From the Same geographic Tegion (Outla) Assay (IHA) were studied, teactive by an' in-nouse indicat Thernaggious with a 95.0% Confidence Interval of 93.15 - 100.0%.
| | IHA | | | |
|---------------------------------------------|-------|----------|--------------|-------|
| Wiener lab<br>Chagatest ELISA<br>rec. v.3.0 | | REACTIVE | Non-Reactive | TOTAL |
| REACTIVE | | 52 | 0 | 52 |
| Non-Reactive | | 0 | 0 | 0 |
| | TOTAL | 52 | 0 | 52 |
2.6 The relative specificity was studied in a panel of 286 specimens from a population of The relative Specificity was stadiou Buenos Aires, Argentina). These specimens were modelate fisk ((riospital de Gilhiodo, Bachoonination Assay(lHA) and Abott Chagas hori-feactive by Forychaco Indicol Homaggiathation Research, 1996)
Antibody ElA. A relative specificity of 99.65% is obtained. (285/286) with a 95.0% Confidence Interval of 98.1 - 99.99%.
| | IHA / ELISA | | | |
|---------------------------------------------|-------------|----------|--------------|-------|
| Wiener lab<br>Chagatest ELISA<br>rec. v.3.0 | | REACTIVE | Non-Reactive | TOTAL |
| REACTIVE | | 0 | 1 | 1 |
| Non-Reactive | | 0 | 285 | 285 |
| TOTAL | | 0 | 286 | 286 |
- 2.7 In a population of moderate risk (Hemocentro de Sao Paulo, Sao Paulo, Brasil), 1236 in a population of moderate fish (Homocon.co tested, together with the IHA, IFA and Specificity of blood donors from the the breaklence of 0.32% and a relative EEIOA. A Sensitively of 1031/122) with a 95.0% Confidence Interval of 99.55 - 100.0%.
{9}------------------------------------------------
| | IHA / IFA / ELISA | | | |
|---------------------------------------------|-------------------|--------------|-------|------|
| | REACTIVE | Non-Reactive | TOTAL | |
| Wiener lab<br>Chagatest ELISA<br>rec. v.3.0 | REACTIVE | 4 | 1 | 5 |
| | Non-Reactive | 0 | 1231 | 1231 |
| | TOTAL | 4 | 1232 | 1236 |
The relative specificity and sensitivity were also studied in the same site, using sera panels selected by their reactivity with II A. In A and Room (1995.0% Confidence interval of specimens a sensitivity of 100% (100% (100% (100%) is specificity of 99.5% (199/200) is
96.38 - 100%. For the panel of non-reactive 100.00% 96.38 - 100%. For the panol of the panel of 97.25 - 99.99%.
| | Sera panel | | | |
|---------------------------------------------|--------------|----------|--------------|-------|
| | | REACTIVE | Non-Reactive | TOTAL |
| Wiener lab<br>Chagatest ELISA<br>rec. v.3.0 | REACTIVE | 100 | 1 | 101 |
| | Non-Reactive | 0 | 199 | 199 |
| | TOTAL | 100 | 200 | 300 |
2.8 A sensitivity panel from a Brazilian was studied (Centro de Imunologia e
ralian and from a Brazilian samarilative samaitive sanaitivity of 100% (188188) A sensitivity panel Trom a Brazilan population Mac Sensitivity of 100% (188/188)
Imunogenetica, Sao Paulo, Brasil), os in 100,000 who 188 secondive speciments for Imunogenetica, Sao Paulo, Brasily, Obtailing on 0%, when 188 reactive specimens for with a 95.0% Confidence interval of 96.1 - 100.0%, which 108 February in-house RIPA
anti-T.cruzi antibodies previously tested by IHA, IFA, ELISA and an in-house RIPA were assayed.
| | IHA / IFA / ELISA / RIPA | | | |
|---------------------------------------------|--------------------------|--------------|-------|-----|
| | REACTIVE | Non-Reactive | TOTAL | |
| Wiener lab<br>Chagatest ELISA<br>rec. v.3.0 | REACTIVE | 188 | 0 | 188 |
| | Non-Reactive | 0 | 0 | 0 |
| | TOTAL | 188 | 0 | 188 |
- 2.9 In a population of 400 specimens from blood donors of Brazil (Centro de Imunologia e In a population of 400 specifiens from blood using the UFA, IFA and ELISA, and ELISA, and Imunogenetica, Sao Faulo, Drasily Similateously of 0.5% and a relative specificity sensitivity of 100% (2/2) is obtains with a 95.0% Confidence Interval of 97.1 – 99.6%.
| | IHA / IFA / ELISA | | |
|---------------------------------------------|-------------------|--------------|-------|
| | REACTIVE | Non-Reactive | TOTAL |
| Wiener lab<br>Chagatest ELISA<br>rec. v.3.0 | 2 | 5 | 7 |
| | 0 | 393 | 393 |
| | 2 | 398 | 400 |
- In a study carried out in Brazil (Fundação Oswaldo Cruz, Rio de Janeiro, Brasil), 2.10 J in a study camed out in Brazil (r and go of disease were tested with Wiener lab
reactive and non-reactive specimens for Chagas' disease were tested with Viener lab reactive and not-reactive specificher or Shagao Vere obtained: from 118 reactive Chagatest ELISA TEC. V.S.O. The Tonoming Toe the relative sensitivity is estimated to be 100% (118/118) with a 95.0% Confidence Interval of 96.92 - 100.0%, while from 796 100% (110/110) with a 95.0% Ochildthous ince systems, the relative specificity is non-leactive "Specimens" (ested" by "the "Same" of the "Same" of 98.9 - 99.92%.
{10}------------------------------------------------
| | IHA / IFA / ELISA / RIPA | | | |
|---------------------------------------------|--------------------------|--------------|-------|-----|
| | REACTIVE | Non-Reactive | TOTAL | |
| Wiener lab<br>Chagatest ELISA<br>rec. v.3.0 | REACTIVE | 118 | 3 | 121 |
| | Non-Reactive | 0 | 793 | 793 |
| | TOTAL | 118 | 796 | 914 |
In a selected population of 70 xenodiagnosed Chagas positive specimens, all 70 2 11 -1 - In a selected population of 70 xenodagnosou chagas posses
(100%) specimens were repeatedly reactive for antibodies to T. cruzi by Wiener lab Chagatest ELISA rec. v.3.0.
Note: Relative refers to a direct comparison of Chagatest ELISA rec. v.3.0 that similari
and no Note: Relative refers to a direct companson or onlying or absence, and no
assays. No attemp has been made to correlate secures geence or absence, and no assays. No attemp has been made to conference with alsocures process.
judgment can be made regarding the predicates assay's accuracy to predict Chagas' disease.
#### Analytical Reactivity 3
3 Analytical Reactivity
Two reactive specimens were serially diluted in T. cruzi antibody non-reactive speciments we Two reactive specimens were senally and in 17 crear and 3 . 3 . Premier Chagas'lyG
tested by three methods (Wiener lab Chagatest ELISA rec. v. 3 .0 . Premier Chagas')gG tested by three methods (Viener lab Chagates Leon Percial South American Indirect
ELISA (Meridian Diag.) and Wiener lass submitted detectable pactivity in the Wiener ELISA (Meridian Diag) and Wieher Tab This (Sellinaecan e creativity in the Wiener
Hemagglutination Assay kit). One specimen exhibited detectable Hemagglutination Assay Kit). One specificer Childing the other one exhibited detectable
lab Chagatest ELISA rec v.3.0 at the sixh dillusing the other one exhibited detectable lab Chagatest ELISA "Tec V.S.S at the elish "Links" in the following table:
reactivity at the fourth dilution. The results are shown in the following table:
Wiener lab Chagatest ELISA rec.v.3.0. PERFORMANCE ON SERIAL DILUTIONS OF Wiener lab Chagatest ELISA PEC.V.S.O. TECH ORIFINGE GARS (GG ELISA (MERIDIAN
REACTIVE SPECIMENS. COMPARISON WITH Premier Chagas' (gG ELISA (MERIDIAN) REACTIVE SPECIMENS. COMFANISON VATT Promation (IHA).
| Specimen Nr.1 (706007) | Wiener lab Chagatest<br>ELISA rec v.3.0 | | Premier Chagas'IgG ELISA<br>(Meridian Diag.) | | Wiener lab<br>IHA |
|------------------------|-----------------------------------------|-----------|----------------------------------------------|-----------|-------------------|
| DILUTION | Absorbance<br>450/650 nm | s/c ratio | Absorbance<br>405 nm | s/c ratio | Result |
| Neata | >3.000 | >9.87 | 1.414 | 2.45 | + |
| 1:2 | >3.000 | >9.87 | 1.283 | 2.22 | + |
| 1:4 | >3.000 | >9.87 | 1.133 | 1.96 | + |
| 1:8 | >3.000 | >9.87 | 0.974 | 1.69 | + |
| 1:16 | 2.341 | 7.70 | 0.735 | 1.27 | + |
| 1:32 | 1.278 | 4.20 | 0.593b | 1.03 | + |
| 1:64 | 0.469b | 1.54 | 0.313 | 0.54 | + |
| 1:128 | 0.089 | 0.29 | 0.214 | 0.37 | + |
| 1:256 | 0.005 | 0.02 | 0.121 | 0.21 | ±b |
| 1:512 | 0.004 | 0.01 | 0.088 | 0.15 | - |
| cutoff | 0.304 | | 0.577 | | |
cimen Nr 1 (706007)
Serial dilutions in normal human serum, seronegative for T. cruzi
Highest dilution considered reactive. b
s/c ratio, signal/cut-off ratio
{11}------------------------------------------------
| Specifieri NI. Z (201012) | Wiener lab Chagatest<br>ELISA rec v.3.0 | | Premier Chagas'IgG ELISA<br>(Meridian Diag.) | | Wiener lab<br>IHA |
|---------------------------|-----------------------------------------|-----------|----------------------------------------------|-----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DILUTION | Absorbance<br>450/650 nm | s/c ratio | Absorbance<br>405 nm | s/c ratio | Result |
| Neat® | >3.000 | >9.87 | 1.090 | 1.89 | + |
| 1:2 | >3.000 | >9.87 | 0.834 | 1.44 | + |
| 1:4 | 2.964 | 9.75 | 0.704° | 1.22 | + |
| 1.8 | 1.751 | 5.76 | 0.530° | 0.92 | 4.6 |
| 1:16 | 0.777" | 2.55 | 0.381 | 0.66 | l |
| 1:32 | 0.308€ | 1.01 | 0.287 | 0.50 | - |
| 1:64 | 0.006 | 0.02 | 0.215 | 0.37 | - |
| 1:128 | 0.004 | 0.01 | 0.109 | 0.19 | - |
| 1:256 | 0.004 | 0.01 | 0.081 | 0.14 | ﻬﻬﺎ ﻓﻬﻮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ |
| 1:512 | 0.004 | 0.01 | 0.039 | 0.07 | |
| cutoff | 0.304 | | 0.577 | | |
| | | | | | |
1778/ מסוקס/ מחוז מח
Serial dilutions in normal human serum, seronegative for T. cruzi
ﻣ Highest dilution considered reactive.
ט Equivocal s/c ratio, signal/cut-off ratio
#### 4 Precision study
- 4 I Intra-assay precision study was determined by assaying three specimens 20 times in intra-assay producibility was determined using both manual (microplate reader from one Turi. Reproducibility Was actorni (Labotech**) assay methods. The intra-assay Molecular Deviation (SD) and Percent coefficient of Variation (%CV) were calculated.
### Manual Intra-assay Precision study
| Sample Nr. | n | Mean | SD (O.D.) | %CV |
|------------|----|-------|-----------|---------|
| 1 | 20 | 2.118 | ± 0.1760 | ± 8.3% |
| 2 | 20 | 2.775 | ± 0.1330 | ± 4.8% |
| 3 | 20 | 0.004 | ± 0.0008 | ± 19.7% |
Automated Intra-assay Precision study
| Sample Nr. | n | Mean | SD (O.D.) | %CV |
|------------|----|-------|--------------|-------------|
| 1 | 20 | 1.798 | $\pm$ 0.2380 | $\pm$ 13.2% |
| 2 | 20 | 2.220 | $\pm$ 0.1710 | $\pm$ 7.7% |
| 3 | 20 | 0.005 | $\pm$ 0.0007 | $\pm$ 14.0% |
4.2 Inter-assay precision study was determined by assaying three specimens 20 times in three consecutive runs. Reproducibility was determined using both manual (microplate thee conseculive rans: Roproadeling and automated (Labotech**) assay methods. The inter-assay Standard Deviation (SD) and Percent Coefficient of Variation (%CV) were calculated.
{12}------------------------------------------------
#### Manual Inter-assav Precision study
| Sample Nr. | n | Mean | SD (O.D.) | %CV |
|------------|----|--------|--------------|-------------|
| 1 | 60 | 2.178 | $\pm$ 0.3439 | $\pm$ 15.7% |
| 2 | 60 | 2.785 | $\pm$ 0.2060 | $\pm$ 7.4% |
| 3 | 60 | 0.0034 | $\pm$ 0.0009 | $\pm$ 26.4% |
#### Automated Inter-assay Precision study
| Sample Nr. | n | Mean | SD (O.D.) | %CV |
|------------|----|--------|--------------|-------------|
| 1 | 60 | 1.893 | $\pm$ 0.3021 | $\pm$ 15.9% |
| 2 | 60 | 2.375 | $\pm$ 0.3730 | $\pm$ 15.7% |
| 3 | 60 | 0.0048 | $\pm$ 0.0014 | $\pm$ 29.2% |
* TM Molecular Devices Corp.
** TM Biochem Immunosystems, Inc
#### Reactivity in patient populations 5
5 - Reactivity in patient populations.
The reactivity of the Wiener lab Chagatest ELISA rec v.3.0 was determined by testing The reactivity of the Wiener lab Shage of patients initially determined to be positive by specifient trom pations in two group of xenodiagnosed positive specimens and in a group of pregnant women from an endemic area of Argentina.
A population of 52 specimens (from Salta, Argentina) from patients with Chagas' disease A population of 52 Specifiche (Iron Odita, Argenanalism Assay (IFA) was studied.
Previously reactive by an in-house Indirect Hemagglutination Assay (IFA) (2006) (50/50) previously reactive by an hagatest ELISA rec v.3.0 a relative sensitivity of 100% (52/52) with a 95.0% Confidence Interval of 93.15 - 100.0% was obtained.
| | IHA | | | |
|------------------------------------------------|--------------|----------|--------------|-------|
| Wiener lab<br>Chagatest<br>ELISA rec.<br>v.3.0 | | REACTIVE | Non-Reactive | TOTAL |
| | REACTIVE | 52 | 0 | 52 |
| | Non-Reactive | 0 | 0 | 0 |
| | TOTAL | 52 | 0 | 52 |
Relative sensitivity of the Wiener lab Chagatest ELISA rec v.3.0 in a selected patient Relative sensitivity of the Vilener labsitive by IHA, IFA and/or ELISA population of 110 specifically (provisually bears old) from an endemic area (Centro de and Tanging In Lago Tratología Regional, Santiago del Estero, Argentina) was estimated to be 99.15% (117/118) with a 95.0% Confidence Interval of 95.3 - 99.98%.
| | IHA / IFA / ELISA | | | |
|------------------------------------------------|-------------------|----------|--------------|-------|
| Wiener lab<br>Chagatest<br>ELISA rec.<br>v.3.0 | | REACTIVE | Non-Reactive | TOTAL |
| | REACTIVE | 117 | 0 | 117 |
| | Non-Reactive | 1 | 0 | 1 |
| | TOTAL | 118 | 0 | 118 |
Specimens from 70 xenodiagnosed positive individuals, all 70 (100%) specimens were Opeomons Trom To xenutibodies to T. cruzi by Wiener lab Chagatest ELISA rec. v.3.0. A sensitivity of 100% with a 95.0% Confidence Interval of 94.87 - 100.0% was obtained.
{13}------------------------------------------------
| | Xenodiagnosis | | | |
|------------------------------------------------|---------------|----------|--------------|-------|
| Wiener lab<br>Chagatest<br>ELISA rec.<br>v.3.0 | | REACTIVE | Non-Reactive | TOTAL |
| | REACTIVE | 70 | 0 | 70 |
| | Non-Reactive | 0 | 0 | 0 |
| | TOTAL | 70 | 0 | 70 |
Specimens from 368 pregnant women from an endemic area (Santiago del Estero, Speciments Trom 300 pregnant women Than an EliusA rec v.3.0 and Premier Chagas'
Argentina), were assayed by Wiener lab Chagatest ELISA rec v.3.0 and Premier Chagas' Argentifia), were assayed by Thener lab Chargated.
IgG ELISA and the results were confirmed by RIPA. The following results were obtained:
| | Premier Chagas' IgG ELISA (Meridian Diag.) | | |
|-----------------------------------------|--------------------------------------------|--------------|--------------------|
| Wiener lab Chagatest<br>ELISA rec v.3.0 | Reactive | Non-reactive | Discordant results |
| | 20 | 334 | 14b |
- All 20 specimens were reactive by Wiener lab ELISA, Meridian ELISA and RIPA. a
- All 20 specimens with discordant results were reactive by RIPA, however:
- riese 14 specimens with disocraant rocation wore reach of and equivocal by ー Meridian ELISA.
- Mendian ELISA.
8 specimens were reactive by Wiener lab Chagatest ELISA rec.v.3.0 and non-reactive । by Meridian ELISA.
- by Mendian ELISA.
1 specimen was equivocal by Wiener lab Chagatest ELISA rec.v.3.0 and reactive by -Meridian ELISA.
- Mendian ELISA.
1 specimen was non-reactive by Wiener lab Chagatest ELISA rec.v.3.0 and equivocal by Meridian ELISA.
6-7 Conclusion Based on the data above mentioned, we believe that the Dased on the data above substantial equivalence to extended oldims commercial distribution intended for similar use
{14}------------------------------------------------
Image /page/14/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes on its wing, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Dr. Viviana Cetola OC/OA Manager Wiener Laboratorios S.A.I.C 2944 Riobamba 2000 Rosario (Santa Fe) Argentina
FEB 1 1 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
k023889 Re:
Trade/Device Name: Chagatest ELISA rec. v.3.0 Regulation Number: 21 CFR § 866.3870 Regulation Name: Trypanosoma spp. Serological reagents Regulatory Class: I Product Code: MIU Dated: November 11, 2003 Received: November 13, 2003
Dear Dr. Cetola:
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). 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.
{15}------------------------------------------------
### Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) rms lot notification. The FDA finding of substantial equivalence of your device to a legally promated 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 of quebecome on atte promise 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,
Saqartys
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
{16}------------------------------------------------
# Indications for Use
510(k) Number (if known):K023889
Device Name:_Chagatest ELISA rec. v.3.0
Indications For Use:
The Wiener Laboratory enzyme-linked Immunosorbent assay (ELISA) recombinante V. 3.0 test The Wieher Laboratory onlynned (using the Biochem Immunosystems, Inc Labotech System 1s a mandar and action of total antibodies (IgG and IgM) to Trypanosoma instrument abouty for the quantal (EDTA, heparin, or Citrate) using recombinant antigens of T. numan ocram and placer are presumptive evidence of present or past infection with cruzi. Trypanosoma cruzi.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
In Vitro Diagnostic Devices (OIVD) Concurrence of
> Office of In Vitro Diagnostic Device Evaluation and Safety
510/k
