K Number
K072732
Device Name
ORTHO T. CRUZI ELISA TEST SYSTEM
Date Cleared
2009-04-15

(567 days)

Product Code
Regulation Number
866.3870
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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.
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 optical 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 lysate (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 T. 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-phenylenediamine (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.
More Information

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 DevicePredicate DevicePredicate Device
Device
CharacteristicORTHO T. cruzi ELISA Test
SystemK930272
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'
diseaseQualitative detection of
antibody to Trypanosoma cruzi,
the causative agent for Chagas'
disease in human serum or
plasma.
Indications for UseReactive 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 PrincipleEnzyme-linked immunosorbent
assay, ELISAEnzyme-linked immunosorbent
assay, ELISAEnzyme-linked immunosorbent
assay, ELISA
Where usedCLIA Certified Clinical
LaboratoryCLIA Certified Clinical
LaboratoryCLIA Certified Clinical
Laboratory
Sample TypeSerum or Plasma
(EDTA, lithium heparin or
citrate)SerumSerum or Plasma
(heparin, EDTA, and citrate
based anticoagulants)
AntigenTrypanosoma spp.
(T. cruzi Tulahuen)Trypanosoma spp.Recombinant T. cruzi antigens
from the trypomastigote
parasite stage: #1, #2, #13,
#30, and #36)
Antigen PrepWhole cell lysate coated onto
plastic microwellsPurified antigens from cultured
T. cruzi organismsRecombinant technology
Sample Volume20 $ μL $10 $ μL $10 $ μL $
ProcedureDiluted sample is incubated
with the antigen prep. After an
appropriate time the serum
dilution in removed, and the
antigen prep is washed. TheDiluted sample is incubated
with the antigen prep. After an
appropriate time the serum
dilution in removed, and the
antigen prep is washed. TheDiluted 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 withantigen prep is overlaid withantigen prep is overlaid with

4

New DevicePredicate DevicePredicate Device
antibody labeled with an
chromogenic substrateantibody labeled with an
chromogenic substrateantibody labeled with an
chromogenic substrate
Conjugate
AntibodyAnti-human IgGAnti-human IgGAnti-human IgG
TracerHorseradish peroxidase with a
Substrate Solution made from
Substrate Buffer and OPD
TabletsHorseradish peroxidase with
substrate 3, 3', 5, 5' -
tetramethylbenzidine (TMB)Horseradish peroxidase with
substrate 3, 3', 5, 5' -
tetramethylbenzidine (TMB)
Antibodies
DetectionThe antibody-HRP bound to the
whole cell lysate-antibody
complex reacts with the OPD
producing a colored end
product. The OD is read
spectrophotometricallyThe antibody-HRP bound to the
whole cell lysate-antibody
complex reacts with the TMB
producing a colored end
product. The OD is read
spectrophotometricallyThe 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 ELISAT. cruzi IFA Result
ResultPositiveNegativeTotal
Repeatedly Reactive8216298
Nonreactive31973976
Total859891074

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
ResultsMost Probable T. cruzi Antibody Status
PositiveNegativeIndeterminate1TOTAL
Repeatedly Reactive926098
Nonreactive19750976
TOTAL9398101074

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)
PopulationPositive Percent
Agreement95% Exact
Confidence
IntervalNegative Percent
Agreement95% Exact
Confidence
Interval
High Risk98.92%
(92/93)94.15% - 99.97%98.96%
(476/481)97.59% - 99.66%
Low Risk100%
(300/300)98.78% - 100%
Pregnancy
Low Risk99.50%
(199/200)97.25% - 99.99%
Total98.92%
(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
ResultT. cruzi IFA ResultTotal
Repeatedly Reactive565992664
Nonreactive511413146
Total570240810

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)
PopulationPositive
Percent
Agreement95% Exact
Confidence
IntervalNegative
Percent
Agreement95% Exact
Confidence
IntervalOverall
Percent
Agreement95% Exact
Confidence
Interval
Serological
Presumed
Positive99.13%
(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 ResultsMost Probable T. cruzi Antibody StatusTOTAL
PositiveNegativeIndeterminate1
Repeatedly Reactive66220664
Nonreactive01460146
TOTAL6621480810

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)
PopulationPositive
Percent
Agreement95% Exact
Confidence
IntervalNegative
Percent
Agreement95% Exact
Confidence
IntervalOverall
Percent
Agreement95% Exact
Confidence
Interval
Serological
Presumed
Positive100%
(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.

9

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).

10

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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

11

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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