(567 days)
Not Found
No
The device description and performance studies focus on standard ELISA technology and spectrophotometric reading, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
This device is an in vitro diagnostic test designed to detect antibodies to Trypanosoma cruzi, which aids in the diagnosis of past infection with Chagas' disease. It is not used for treatment or therapy.
Yes
The device is an in vitro diagnostic test designed for the qualitative detection of antibodies to Trypanosoma cruzi, which can be used for the laboratory diagnosis of individuals with Chagas' disease when combined with other clinical information.
No
The device description clearly outlines a laboratory assay (ELISA) that involves physical reagents, microwells, and spectrophotometric reading, 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 / Indications for Use" section explicitly states that the device is for the "in vitro qualitative detection of antibodies... to Trypanosoma cruzi... in human adult serum... and plasma". The term "in vitro" means "in glass" or "in the lab," referring to tests performed outside of a living organism.
- Device Description: The description details an "enzyme-linked immunosorbent assay (ELISA)," which is a common laboratory technique used for in vitro diagnostic testing. It describes the process of using patient samples (serum and plasma) and reagents to detect the presence of antibodies.
- Purpose: The purpose of the test is to aid in the "laboratory diagnosis of individuals with Chagas' disease," which is a diagnostic purpose performed on biological samples outside the body.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ORTHO T. cruzi ELISA Test System is an enzyme-linked immunosorbent assay for the in vitro qualitative detection of antibodies (Immunoglobulin G) to Trypanosoma cruzi (T. cruzi) in human adult serum (glass, plastic, or serum separator tubes) and plasma (EDTA, lithium heparin or citrate) using whole-cell lysate antigens. Reactive assay results are presumplive evidence of past infection, and in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with Chagas' disease.
Definitive diagnosis of an acute phase of infection (including acute congenital infection) must be made by alternate methods, e.g., hemoculture, blood smear.
This test is not intended for use on samples of cord blood or screening blood or plasma donors.
Product codes (comma separated list FDA assigned to the subject device)
MIU
Device Description
The ORTHO T. cruzi ELISA Test System is an enzyme-linked immunosorbent assay (ELISA). ELISA technology utilizes the principle that antibodies bound to the solid phase can be detected by complementary antibodies or antigens labeled with an enzyme capable of acting on a chromogenic substrate. When substrate is applied, the presence of antigens or antibodies can be detected by development of a colored end product. The ontical densities are read spectrophotometrically.
This ELISA was developed to detect human antibodies to T. cruzi in serum and plasma. The assay utilizes microwells coated with a whole-cell lysate containing T. cruzi antigens as the solid phase. The assay procedure is a three-stage test carried out in a microwell coated with lysale (antigens) prepared from T. cruzi. In the first stage, test specimen, Negative Control, and Positive Calibrator are diluted directly in the test well containing Specimen Diluent, and incubated for a specified length of time. If antibodies to 7. cruzi are present, antigen-antibody complexes will form on the microwell surface. If antibodies to T. cruzi are absent, complexes will not form. Unbound antibodies in the sample will be removed during the subsequent wash step.
In the second stage, murine monoclonal antibody conjugated with Horseradish Peroxidase (Conjugate) is added to the test well. The Conjugate binds specifically to the antibody portion of the antigen-antibody complex. If complexes are not present, the unbound Conjugate is removed by the subsequent wash step.
In the third stage, an enzyme detection system composed of o-phenvlenediamine (OPD) and hydrogen peroxide is added to the test well. If bound Conjugate is present, the OPD with be oxidized, resulting in a colored end product. Sulfuric acid is then added to stop the reaction. The color intensity depends on the amount of bound Conjugate and, therefore, is a function of the concentration of antibodies to T. cruzi present in the specimen. The intensity of color in the substrate solution is then determined with a microwell reader (spectrophotometer) designed to measure light absorbance in a microwell.
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
Adult
Intended User / Care Setting
CLIA Certified Clinical Laboratory
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
Specimens from 1074 subjects at high or low risk for T. cruzi infection were tested with a comparator T. cruzi IFA and with the ORTHO T. cruzi ELISA Test System.
A total of 810 specimens were included in the T. cruzi scrological presumed positive population based upon two positive serological tests for T. cruzi antibodies in use in the countries of origin (i.e., ELISA, IFA, hemagglutination, or complement fixation). The comparator T. cruzi IFA was not used to admit specimens to the study. The specimens were obtained from the endemic countries of Bolivia (17.8%), Brazil (24.7%), Chile (10.6%), Gualemala (2.2%), Mexico (32.5%) and Nicaragua (12.2%). ORTHO T. cruzi ELISA testing was performed at two testing sites in Camp Hill, PA and Newark, NJ.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
ORTHO T. cruzi ELISA and T. cruzi IFA Results among High Risk and Low Risk Subjects
Specimens from 1074 subjects at high or low risk for T. cruzi infection were tested with a comparator T. cruzi IFA and with the ORTHO T. cruzi ELISA Test System.
- Total sample size: 1074
- Positive Percent Agreement (High Risk): 96.47% (82/85) with a 95% Exact Confidence Interval of 90.03% - 99.27%
- Negative Percent Agreement (High Risk): 96.93% (474/489) with a 95% Exact Confidence Interval of 94.99% - 98.27%
- Negative Percent Agreement (Low Risk): 100% (300/300) with a 95% Exact Confidence Interval of 98.78% - 100%
- Negative Percent Agreement (Pregnancy Low Risk): 99.50% (199/200) with a 95% Exact Confidence Interval of 97.25% - 99.99%
- Total Positive Percent Agreement: 96.47% (82/85) with a 95% Exact Confidence Interval of 90.03% - 99.27%
- Total Negative Percent Agreement: 98.38% (973/989) with a 95% Exact Confidence Interval of 97.39% - 99.07%
ORTHO T. cruzi ELISA Results and Most Probable T. cruzi Antibody Status among High Risk and Low Risk Subjects
- Total sample size: 1074
- Positive Percent Agreement (High Risk): 98.92% (92/93) with a 95% Exact Confidence Interval of 94.15% - 99.97%
- Negative Percent Agreement (High Risk): 98.96% (476/481) with a 95% Exact Confidence Interval of 97.59% - 99.66%
- Negative Percent Agreement (Low Risk): 100% (300/300) with a 95% Exact Confidence Interval of 98.78% - 100%
- Negative Percent Agreement (Pregnancy Low Risk): 99.50% (199/200) with a 95% Exact Confidence Interval of 97.25% - 99.99%
- Total Positive Percent Agreement: 98.92% (92/93) with a 95% Exact Confidence Interval of 94.15% - 99.97%
- Total Negative Percent Agreement: 99.39% (975/981) with a 95% Exact Confidence Interval of 98.67% - 99.78%
ORTHO T. cruzi ELISA versus T. cruzi IFA Results in Specimens Presumed Positive by Se Methods (N=810)
- Total sample size: 810
- Positive Percent Agreement: 99.13% (565/570) with a 95% Exact Confidence Interval of 97.96% - 99.71%
- Negative Percent Agreement: 58.75% (141/240) with a 95% Exact Confidence Interval of 52.24% - 65.04%
- Overall Percent Agreement: 87.16% (706/810) with a 95% Exact Confidence Interval of 84.66% - 89.39%
ORTHO T. cruzi ELISA versus Most Probable T. cruzi Antibody Status for the Serological Presumed Positive Population (N=810)
- Total sample size: 810
- Positive Percent Agreement: 100% (662/662) with a 95% Exact Confidence Interval of 99.44% - 100%
- Negative Percent Agreement: 98.65% (146/148) with a 95% Exact Confidence Interval of 95.20% - 99.84%
- Overall Percent Agreement: 99.75% (808/810) with a 95% Exact Confidence Interval of 99.11% - 99.97%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See "Summary of Performance Studies" section for various percentage agreements and confidence intervals.
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.
K930272 Hemagen Chagas' Kit (EIA Method) - Hemagen Diagnostics, Inc., K023889 Enzyme Linked Immunosorbent Assay, T. cruzi - Wiener Laboratories
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
§ 866.3870
Trypanosoma spp. serological reagents.(a)
Identification. Trypanosoma spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toTrypanosoma spp. in serum. The identification aids in the diagnosis of trypanosomiasis, a disease caused by parasitic protozoans belonging to the genusTrypanosoma. 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.(b)
Classification. Class I (general controls).
0
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K072732
l Submitter Name, Address, and Contact
Ortho-Clinical Diagnostics, Inc. 1001 US Highway 202 Raritan, NJ 08869-0606
Contact Person: Laura C. Vellucci (908) 218-8532
2 Preparation Date
Date 510(k) prepared: September 20, 2007
3 Device Name
Trypanosoma cruzi (T. cruzi) Whole Cell Lysate Antigen, ORTHO® T. cruzi ELISA Test System
Common Name: Trypanosoma cruzi (T. cruzi) Whole Cell Lysate Antigen ORTHO® T. cruzi ELISA Test System Trade Name: Classification Name: Trypanosoma spp. Serological reagents (21 CFR 866.3870)
Assay Class: I (general controls)
4 Predicate Device
The ORTHO T. cruzi ELISA Test System is substantially equivalent to K930272 Hemagen Chagas' Kit (EIA Method) - Hemagen Diagnostics, Inc., and/or K023889 Enzyme Linked Immunosorbent Assay, T. cruzi - Wiener Laboratories and the T. cruzi indirect immunofluorescence assay, IFA, performed by Focus Diagnostics, Cypress, CA is the comparator method.
5 Device Description
The ORTHO T. cruzi ELISA Test System is an enzyme-linked immunosorbent assay (ELISA). ELISA technology utilizes the principle that antibodies bound to the solid phase can be detected by complementary antibodies or antigens labeled with an enzyme capable of acting on a chromogenic substrate. When substrate is applied, the presence of antigens or antibodies can be detected by development of a colored end product. The ontical densities are read spectrophotometrically.
Ortho-Clinical Diagnostics, Inc.
APR 1 5 2009
.
1
This ELISA was developed to detect human antibodies to T. cruzi in serum and plasma. The assay utilizes microwells coated with a whole-cell lysate containing T. cruzi antigens as the solid phase. The assay procedure is a three-stage test carried out in a microwell coated with lysale (antigens) prepared from T. cruzi. In the first stage, test specimen, Negative Control, and Positive Calibrator are diluted directly in the test well containing Specimen Diluent, and incubated for a specified length of time. If antibodies to 7. cruzi are present, antigen-antibody complexes will form on the microwell surface. If antibodies to T. cruzi are absent, complexes will not form. Unbound antibodies in the sample will be removed during the subsequent wash step.
In the second stage, murine monoclonal antibody conjugated with Horseradish Peroxidase (Conjugate) is added to the test well. The Conjugate binds specifically to the antibody portion of the antigen-antibody complex. If complexes are not present, the unbound Conjugate is removed by the subsequent wash step.
In the third stage, an enzyme detection system composed of o-phenvlenediamine (OPD) and hydrogen peroxide is added to the test well. If bound Conjugate is present, the OPD with be oxidized, resulting in a colored end product. Sulfuric acid is then added to stop the reaction. The color intensity depends on the amount of bound Conjugate and, therefore, is a function of the concentration of antibodies to T. cruzi present in the specimen. The intensity of color in the substrate solution is then determined with a microwell reader (spectrophotometer) designed to measure light absorbance in a microwell.
Special Instrumentation Requirements
There are no special ELISA instrument requirements for the device. All 510(k) performance testing was conducted using semi-automated instrumentation defined as:
- . Ortho Summit Sample Handling System or
- Fixed or Adjustable Single-Channel Micropipette .
- . AutoWash 96 (multichannel aspirator-washer device)
- . AutoReader IV (dual wavelength microwell reader)
- Model 120 Incubator .
- Ortho Assay Software (OAS) .
- (instrumentation process and data management software)
- . Ortho T. cruzi CT (Clinical Trial) OAPD (Ortho Assay Protoco| Disk)
The instructions for use call for:
- Adjustable multichannel micropipettes, or equivalent reagent dispenser capable of . delivering 50 uL and 200 uL with at least ± 5% accuracy
- Fixed or adjustable single channel micropipettes or equivalent pipetter-dilutor capable of . delivering 20 µL and 200 µL with at least ± 5% accuracy
- . 50 uL to 300 uL disposable pipette tips or equivalent
- . 20 uL disposable pipette tips or equivalent
- Appropriately sized serological pipette or graduated cylinder .
2
- . Multichannel micropipette reservoirs or equivalent containers
- . OCD microwell plate or strip washer or equivalent multichannel microwell aspiratorwasher device capable of at least 5 cycles of wash by dispensing and aspirating at least 700 uL of fluid per well and leaving a full well of fluid to soak at least 20 seconds.
- . OCD microwell plate or strip reader or equivalent dual wavelength microwell reader capable of reading at 490 or 492 nm with a reference filter of 620 or 630 nm. A 610 nm filter is required for performing Sample Omission Monitoring (SOM) reads. Linearity of the microwell reader must range from at least 0 to 2.5 absorbance units.
- . 37℃ ± 1℃ microwell incubator (dry)
Users are instructed, when using semi-automated instruments, to follow the procedures that are contained in the operator's manual provided by the device manufacturer. Lahoratories must follow their approved validation procedures to demonstrate compatibility of this product on semi-automated and automated systems.
6 Device Intended Use
ORTHO T. cruzi ELISA Test System is an enzyme-linked immunosorbent assay for the in vitro qualitative detection of antibodies (Immunoglobulin G) to Trypanosoma cruzi (T. cruzi) in human adult serum (glass, plastic, or serum separator tubes) and plasma (EDTA, lithium heparin or citrate) using whole-cell lysate antigens. Reactive assay results are presumplive evidence of past infection, and in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with Chagas' disease.
Definitive diagnosis of an acute phase of infection (including acute congenital infection) must be made by alternate methods, e.g., hemoculture, blood smear.
This test is not intended for use on samples of cord blood or screening blood or plasma donors.
3
7 Comparison to Predicate Device
The ORTHO T. cruzi ELISA Test System is substantially equivalent to K930272 Hemagen Chagas` Kit (EIA Method) - Hemagen Diagnostics, Inc., and/or K023889 Enzyme Linked Immunosorbent Assay, 7. cruzi -Wiener Laboratories and the 7. cruzi indirect immunofluorescence assay, IFA, performed by Focus Diegnostics, Cypress, CA is the comparator method.
Comparison of the ORTHO T. cruzi ELISA Test System to the K930272 Hemagen Chagas' Kit (EIA Method) - Hemagen Diagnostics, Inc., and K023889 Enzyme Linked Immunosorbent Assay, T. cruzi - Wiener Laboratories
New Device | Predicate Device | Predicate Device | ||
---|---|---|---|---|
Device | ||||
Characteristic | ORTHO T. cruzi ELISA Test | |||
System | K930272 | |||
Hemagen Chagas' Kit | ||||
(EIA Method) - | ||||
Hemagen Diagnostics, Inc. | K023889 | |||
Enzyme Linked | ||||
Immunosorbent Assay, | ||||
T. cruzi - | ||||
Wiener Laboratories | ||||
Intended Use | ... for the in vitro qualitative | |||
detection of antibodies | ||||
((Immunoglobulin (G) to | ||||
Trypanosoma cruzi (T. cruzi) | ... for the detection of | |||
circulating antibodies to | ||||
Trypanosoma cruzi, the | ||||
causative agent of Chagas' | ||||
disease | Qualitative detection of | |||
antibody to Trypanosoma cruzi, | ||||
the causative agent for Chagas' | ||||
disease in human serum or | ||||
plasma. | ||||
Indications for Use | Reactive assay results are | |||
presumptive evidence of past | ||||
infection, and in conjunction | ||||
with other serological and | ||||
clinical information, may be | ||||
used for the laboratory | ||||
diagnosis of individuals with | ||||
Chagas' disease. | When used according to | |||
instructions, the kit is useful in | ||||
exhibiting prior exposure to T. | ||||
cruzi and as an aid in the | ||||
diagnosis of Chagas' disease. | When using according to | |||
instructions, the kit is useful in | ||||
establishing prior exposure to T. | ||||
cruzi and as an aid in the | ||||
diagnosis of Chagas' disease. | Deleted: A | |||
Basic Principle | Enzyme-linked immunosorbent | |||
assay, ELISA | Enzyme-linked immunosorbent | |||
assay, ELISA | Enzyme-linked immunosorbent | |||
assay, ELISA | ||||
Where used | CLIA Certified Clinical | |||
Laboratory | CLIA Certified Clinical | |||
Laboratory | CLIA Certified Clinical | |||
Laboratory | ||||
Sample Type | Serum or Plasma | |||
(EDTA, lithium heparin or | ||||
citrate) | Serum | Serum or Plasma | ||
(heparin, EDTA, and citrate | ||||
based anticoagulants) | ||||
Antigen | Trypanosoma spp. | |||
(T. cruzi Tulahuen) | Trypanosoma spp. | Recombinant T. cruzi antigens | ||
from the trypomastigote | ||||
parasite stage: #1, #2, #13, | ||||
#30, and #36) | ||||
Antigen Prep | Whole cell lysate coated onto | |||
plastic microwells | Purified antigens from cultured | |||
T. cruzi organisms | Recombinant technology | |||
Sample Volume | 20 $ μL $ | 10 $ μL $ | 10 $ μL $ | |
Procedure | Diluted sample is incubated | |||
with the antigen prep. After an | ||||
appropriate time the serum | ||||
dilution in removed, and the | ||||
antigen prep is washed. The | Diluted sample is incubated | |||
with the antigen prep. After an | ||||
appropriate time the serum | ||||
dilution in removed, and the | ||||
antigen prep is washed. The | Diluted sample is incubated | |||
with the antigen prep. After an | ||||
appropriate time the serum | ||||
dilution in removed, and the | ||||
antigen prep is washed. The | ||||
antigen prep is overlaid with | antigen prep is overlaid with | antigen prep is overlaid with |
4
New Device | Predicate Device | Predicate Device | |
---|---|---|---|
antibody labeled with an | |||
chromogenic substrate | antibody labeled with an | ||
chromogenic substrate | antibody labeled with an | ||
chromogenic substrate | |||
Conjugate | |||
Antibody | Anti-human IgG | Anti-human IgG | Anti-human IgG |
Tracer | Horseradish peroxidase with a | ||
Substrate Solution made from | |||
Substrate Buffer and OPD | |||
Tablets | Horseradish peroxidase with | ||
substrate 3, 3', 5, 5' - | |||
tetramethylbenzidine (TMB) | Horseradish peroxidase with | ||
substrate 3, 3', 5, 5' - | |||
tetramethylbenzidine (TMB) | |||
Antibodies | |||
Detection | The antibody-HRP bound to the | ||
whole cell lysate-antibody | |||
complex reacts with the OPD | |||
producing a colored end | |||
product. The OD is read | |||
spectrophotometrically | The antibody-HRP bound to the | ||
whole cell lysate-antibody | |||
complex reacts with the TMB | |||
producing a colored end | |||
product. The OD is read | |||
spectrophotometrically | The antibody-HRP bound to the | ||
recombinant antigens-antibody | |||
complex reacts with the TMB | |||
producing a colored end | |||
product. The OD is read | |||
spectrophotometrically |
Performance
ORTHO T. cruzi ELISA and T. cruzi IFA Results among High Risk and Low Risk Subjects
Specimens from 1074 subjects at high or low risk for T. cruzi infection were tested with a comparator T. cruzi IFA and with the ORTHO T. cruzi ELISA Test System. The results are presented in the following table.
ORTHO T. cruzi ELISA | T. cruzi IFA Result | ||
---|---|---|---|
Result | Positive | Negative | Total |
Repeatedly Reactive | 82 | 162 | 98 |
Nonreactive | 31 | 973 | 976 |
Total | 85 | 989 | 1074 |
5
The table below summarizes the percent agreement he ORTHO T. cruzi ELISA and the T. cruzi IFA. Data are listed by population and overall, with positive and negative percent agreement and 95% exact confidence intervals (CI).
| Population | Positive Percent
Agreement | 95% Exact
Confidence
Interval | Negative Percent
Agreement | 95% Exact
Confidence
Interval |
|-----------------------|-------------------------------|-------------------------------------|-------------------------------|-------------------------------------|
| High Risk | 96.47%
(82/85) | 90.03% - 99.27% | 96.93%
(474/489) | 94.99% - 98.27% |
| Low Risk | | | 100%
(300/300) | 98.78% - 100% |
| Pregnancy
Low Risk | | | 99.50%
(199/200) | 97.25% - 99.99% |
| Total | 96.47%
(82/85) | 90.03% - 99.27% | 98.38% (973/989) | 97.39% - 99.07% |
ORTHO T. cruzi ELISA Results and Most Probable T. cruzi Antibody Status among High Risk and Low Risk Subjects
Because the T. cruzi IFA is a non-reference standard for detection of antibodies to T. cruzi, the most probable T. cruzi antibody status of the high and low risk study subjects was determined by ORTHO T. cruzi ELISA Test System, comparator T. cruzi IFA and supplemental T. cruzi RIPA testing according to a pre-specified testing algorithm. Specimens not tested with RIPA that were negative with both the ORTHO T. cruzi ELISA and the T. cruzi IFA were assigned a most probable T. cruzi antibody status of negative. Specimens tested with the RIPA were assigned a most probable T. cruzi antibody status of positive, negative or indeterminate based on the RIPA results.
A comparison of the ORTHO T. cruzi ELISA results to most probable T. cruzi antibody status is presented in the following table.
| ORTHO T. cruzi ELISA Results and Most Probable T. cruzi Antibody Status
in the High Risk and Low Risk Populations (N=1074) | ||||
---|---|---|---|---|
ORTHO T. cruzi ELISA | ||||
Results | Most Probable T. cruzi Antibody Status | |||
Positive | Negative | Indeterminate1 | TOTAL | |
Repeatedly Reactive | 92 | 6 | 0 | 98 |
Nonreactive | 1 | 975 | 0 | 976 |
TOTAL | 93 | 981 | 0 | 1074 |
6
The table below summarizes the percent agreement between the ORTHO T. cruzi ELISA and most probable T. cruzi antibody status. Data are listed by population and overall, with positive and negative percent agreement and 95% exact confidence intervals.
| Positive and Negative Percent Agreement of the ORTHO T. cruzi ELISA with
Most Probable T. cruzi Antibody Status by High Risk and Low Risk Study Population (N=1074) | ||||
---|---|---|---|---|
Population | Positive Percent | |||
Agreement | 95% Exact | |||
Confidence | ||||
Interval | Negative Percent | |||
Agreement | 95% Exact | |||
Confidence | ||||
Interval | ||||
High Risk | 98.92% | |||
(92/93) | 94.15% - 99.97% | 98.96% | ||
(476/481) | 97.59% - 99.66% | |||
Low Risk | 100% | |||
(300/300) | 98.78% - 100% | |||
Pregnancy | ||||
Low Risk | 99.50% | |||
(199/200) | 97.25% - 99.99% | |||
Total | 98.92% | |||
(92/93) | 94.15% - 99.97% | 99.39% (975/981) | 98.67% - 99.78% |
Specimens Presumed Positive for Antibodies to T. cruzi by Serological Methods ORTHO T. cruzi ELISA versus T. cruzi IFA
A total of 810 specimens were included in the T. cruzi scrological presumed positive population based upon two positive serological tests for T. cruzi antibodies in use in the countries of origin (i.e., ELISA, IFA, hemagglutination, or complement fixation). The comparator T. cruzi IFA was not used to admit specimens to the study. The specimens were obtained from the endemic countries of Bolivia (17.8%), Brazil (24.7%), Chile (10.6%), Gualemala (2.2%), Mexico (32.5%) and Nicaragua (12.2%). ORTHO T. cruzi ELISA testing was performed at two testing sites in Camp Hill, PA and Newark, NJ. Direct comparison of the ORTHO T. cruzi ELISA with the T. cruzi IFA is presented in the following table.
| ORTHO T. cruzi ELISA vs. T. cruzi IFA Results in Specimens Presumed Positive by Se
Methods (N=810) | |||
---|---|---|---|
ORTHO T. cruzi ELISA | |||
Result | T. cruzi IFA Result | Total | |
Repeatedly Reactive | 565 | 992 | 664 |
Nonreactive | 51 | 1413 | 146 |
Total | 570 | 240 | 810 |
All 141 specimens were negative with the 7. cruzi RIPA.
7
Positive, negative and overall percent agreement of the ORTHO T. cruzi ELISA with the T. cruzi IFA and 95% exact confidence intervals are shown in the following table.
| Positive, Negative and Overall Percent Agreement of the ORTHO T. cruzi ELISA with the T. cruzi IFA
in the Serological Presumed Positive Population (N=810) | ||||||
---|---|---|---|---|---|---|
Population | Positive | |||||
Percent | ||||||
Agreement | 95% Exact | |||||
Confidence | ||||||
Interval | Negative | |||||
Percent | ||||||
Agreement | 95% Exact | |||||
Confidence | ||||||
Interval | Overall | |||||
Percent | ||||||
Agreement | 95% Exact | |||||
Confidence | ||||||
Interval | ||||||
Serological | ||||||
Presumed | ||||||
Positive | 99.13% | |||||
(565/570) | 97.96% - | |||||
99.71% | 58.75% | |||||
(141/240) | 52.24% - | |||||
65.04% | 87.16% | |||||
(706/810) | 84.66% - | |||||
89.39% |
ORTHO T. cruzi ELISA versus Most Probable T. cruzi Antibody Status
Because the T. cruzi IFA is a non-reference standard for detection of antibodies to T. cruzi, the most probable T. cruzi antibody status of the study subjects presumed positive by serologic methods was determined by ORTHO T. cruzi ELISA Test System, comparator T. cruzi IFA and supplemental T. cruzi RIPA testing according to a pre-specified testing and interpretation algorithm. Specimens that were ORTHO T. cruzi ELISA repeatedly reactive and positive with the T. cruzi IFA were assigned a most probable T. cruzi antibody status of positive and were not tested with the T. cruzi RIPA. All specimens negative with both assays or with discordant results between the two assays were tested with the T. cruzi RIPA and assigned a most probable T. cruzi antibody status based upon the RIPA results. A comparison of ORTHO T. cruzi ELISA results and most probable 7. cruzi antibody status is presented in the following table
ORTHO T. cruzi ELISA Results | Most Probable T. cruzi Antibody Status | TOTAL | ||
---|---|---|---|---|
Positive | Negative | Indeterminate1 | ||
Repeatedly Reactive | 662 | 2 | 0 | 664 |
Nonreactive | 0 | 146 | 0 | 146 |
TOTAL | 662 | 148 | 0 | 810 |
probable T. cruzi antibody status of indeterminate among the serological presumed positive specimens tested with RIPA.
8
Positive, negative and overall percent agreement of the ORTHO T. cruzi ELISA with most probable T. cruzi antibody status and 95% exact confidence intervals are shown in the following table.
| Positive, Negative and Overall Percent Agreement of the ORTHO T. cruzi ELISA with Most Probable
T. cruzi Antibody Status for the Serological Presumed Positive Population (N=810) | ||||||
---|---|---|---|---|---|---|
Population | Positive | |||||
Percent | ||||||
Agreement | 95% Exact | |||||
Confidence | ||||||
Interval | Negative | |||||
Percent | ||||||
Agreement | 95% Exact | |||||
Confidence | ||||||
Interval | Overall | |||||
Percent | ||||||
Agreement | 95% Exact | |||||
Confidence | ||||||
Interval | ||||||
Serological | ||||||
Presumed | ||||||
Positive | 100% | |||||
(662/662) | 99.44% - | |||||
100% | 98.65% | |||||
(146/148) | 95.20% - | |||||
99.84% | 99.75% | |||||
(808/810) | 99.11% - | |||||
99.97% |
8 Conclusions
The ORTHO T. cruzi ELISA Test System is substantially equivalent to K930272 Hemagen Chagas' Kit (EIA Method) . Hemagen Diagnostics, Inc., and/or K023889 Enzyme Linked Immunosorbent Assay, T. cruzi - Wiener Laboratories
The data presented in the Premarket notification provide a reasonable assurance the ORTHO T. cruzi ELISA Test System is safe and effective for the stated intended use and is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ortho-Clinical Diagnostics, Inc. Laura C. Vellucci 1001 US Highway 202 Raritan, NJ 08869-0606
APR 1 5 2009
Re: K072732
Trade/Device Name: ORTHO® T. cruzi ELISA Test System Regulation Number: 21 CFR 866.3870 Regulation Name: Trypanosomma spp. Serological reagents Regulatory Class: Class I Product Code: MIU Dated: September 29, 2008 Received: October 1, 2008
Dear Ms. Vellucci:
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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Sally attignto
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
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510(k) Number (if known): K072732
Device Name:
Trypanosoma cruzi (T. cruzi) Whole Cell Lysate Antigen, ORTHO® T. cruzi ELISA Test System
Indications for Use:
ORTHO T. cruzi ELISA Test System is an enzyme-linked immunosorbent assay for the in vitro qualitative detection of antibodies (Immunoglobulin G) to Trypanosoma cruzi (T. cruzi) in human adult serum (glass, plastic, or serum separator tubes) and plasma (EDTA, lithium heparin or citrate) using whole-cell lysate antigens. Reactive assay results are presumptive evidence of past infection, and in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with Chagas' disease.
Definitive diagnosis of an acute phase of infection (including acute congenital infection) must be made by alternate methods, e.g., hemoculture, blood smear.
This test is not intended for use on samples of cord blood or screening blood or plasma donors.
Prescription Use ਮ (Per 21 CFR 801 Subpart D) AND/OR
Over -The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnos of Marces
Ortho-Clinical Diagnostics, Inc.
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Office of In Vitro Diagnostir Device Evaluation and Sately
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