(281 days)
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No
The device description details a standard ELISA assay with spectrophotometric or visual reading, and there is no mention of AI or ML in the text.
No
The device is an ELISA test designed to detect antibodies for diagnostic purposes, not to treat a condition.
Yes
The device determines the presence and quantity of IgG antibodies to Entamoeba histolytica in patient serum, which is used to diagnose infection. This aligns with the definition of a diagnostic device as it provides information for the detection of a disease or condition.
No
The device description clearly describes a physical ELISA kit with microwells, reagents, and a colorimetric reaction, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the "qualitative and/ or quantitative determination of serum IgG antibodies to Entamoeba histolytica using an Enzyme-Linked Immunosorbent Assay (ELISA) technique." This describes a test performed on a biological sample (serum) outside of the body to diagnose or detect a condition (presence of antibodies to Entamoeba histolytica).
- Device Description: The description details an ELISA, which is a common in vitro diagnostic technique. It describes the process of using reagents to detect antibodies in a patient's serum sample.
- Sample Type: The device uses "patient's serum," which is a biological sample.
- Performance Studies: The document describes testing the device with "Serum samples confirmed as positive or negative for antibodies to E. histolytica," further indicating its use with biological samples for diagnostic purposes.
- Key Metrics: The reporting of Sensitivity and Specificity are standard metrics used to evaluate the performance of diagnostic tests.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the device is for the qualitative and/ or quantitative determination of serum IgG antibodies to Entamoeba histolytica using an Enzyme-Linked Immunosorbent Assay (ELISA) technique. The intended use for the device is as a supportive test kit in the differential diagnosis of symptomatic patients. When used as a supportive test, a serological test is useful not only to detect the presence of these antibodies but also to exclude amebiasis as the diagnosis. Since the kit detects IgG antibodies, a positive test may not indicate an active infection since the IgG antibodies exist for years.
Product codes
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Device Description
The device is an Enzyme Linked Immunosorbent Assay (ELISA). The antigen capture takes place in microwells. During the first incubation, antibodies in the patient's serum binds to antigen attached to the test wells. After washing the excess antibodies away, an enzyme complex binds to the antigen-antibody complex. After washings that remove unbound enzyme, a substrate is added which develops a blue color in the presence of the enzyme complex and peroxide. The stop solution ends the reaction and turns the The blue color to yellow. results read may be be spectrophotometrically with a microplate reader or visually.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Appropriate laboratory sites of use for this device would include laboratories in endemic third world countries and immigration centers in industrialized countries.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Serum samples confirmed as positive or negative for antibodies to E. histolytica were tested by the device.
Summary of Performance Studies
Clinical Laboratory Bench Studies were performed to validate SUBSTANTIAL EQUIVALENCE to the original predicate kit.
Sensitivity/ Specificity Testing: Serum samples confirmed as positive or negative for antibodies to E. histolytica were tested by the device. Sensitivity and specificity values were calculated and compared with sensitivity/ specificity values for the original 510(k) kit. Substantial equivalency was validated by the testing.
Additional Testing: Further bench studies validated substantial equivalency in the following identified parameters:
- Testing for "visual" interpretation was performed.
- Testing for Intra-assay (Mith-in) Run Precision was performed.
- Testing for Run-to-Run Precision was performed.
- Testing for Cross-reactivity
Key Metrics
Original 510(k) Test Kit: Sensitivity = 95%, Specificity = 97%
Modified Test Kit: Sensitivity = 100%, Specificity = 92%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3220
Entamoeba histolytica serological reagents.(a)
Identification. Entamoeba histolytica serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toEntamoeba histolytica in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyEntamoeba histolytica directly from clinical specimens. The identification aids in the diagnosis of amebiasis caused by the microscopic protozoan parasiteEntamoeba histolytica and provides epidemiological information on diseases caused by this parasite. The parasite may invade the skin, liver, intestines, lungs, and diaphragm, causing disease conditions such as indolent ulcers, an amebic hepatitis, amebic dysentery, and pulmonary lesions.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
0
AUG - 8 1996
Page 2 of 3 Summary of 510(k) Safety and Effectiveness information. Trade / Proprietary Name: TREMD Amebiasis (Butamoeba histolytica)
Serological BLISA Test System.
DESCRIPTION and INTENDED USE of the DEVICE:
The intended use of the device is for the qualitative and/ or quantitative determination of serum IgG antibodies to Entamoeba histolytica using an Enzyme-Linked Immunosorbent Assay (ELISA) technique.
Entamoeba histolytica is a protozoan parasite responsible for the disease state of amebiasis. This parasite is endemic in developing countries but is rare in most industrial nations. An infection with the organism originates in the intestine, but the organism may become invasive and may result in amebic liver abscesses. When tissues are invaded, antibodies are often formed.
Appropriate laboratory sites of use for this device would include laboratories in endemic third world countries and immigration centers in industrialized countries. The intended use for the device is as a supportive test kit in the differential diagnosis of symptomatic patients. When used as a supportive test, a serological test is useful not only to detect the presence of these antibodies but also to exclude amebiasis as the diagnosis. Since the kit detects IgG antibodies, a positive test may not indicate an active infection since the IgG antibodies exist for years.
SCIENTIFIC PRINCIPLES:
The device is an Enzyme Linked Immunosorbent Assay (ELISA). The antigen capture takes place in microwells. During the first incubation, antibodies in the patient's serum binds to antigen attached to the test wells. After washing the excess antibodies away, an enzyme complex binds to the antigen-antibody complex. After washings that remove unbound enzyme, a substrate is added which develops a blue color in the presence of the enzyme complex and peroxide. The stop solution ends the reaction and turns the The blue color to yellow. results read may be be spectrophotometrically with a microplate reader or visually.
TECHNOLOGY:
The modifications of the submitted device do not affect the technological characteristics of the predicate device.
The modifications include: (1) changing the test sample preparation to facilitate ease of use, (2) changing to a 1-component combined TMB substrate system vs. a 2-component TMB substrate system with corresponding appropriate stop solution, (3) reducing the number of repetitive washes after each incubation step, (4) using a powder packet of PBS with a surfactant vs. a liquid concentrate, and (5) using more than one antigen source on the microwell plates.
1
Page 3 of 3 Summary of 510 k) Safety and Effectiveness information. Trade / Proprietary Name: TREND Amebiasis (Entanoeba histolgtica) Serological ELISA Test Systen. K954996
PERFORMANCE TESTING:
Clinical Laboratory Bench Studies were performed to validate SUBSTANTIAL EQUIVALENCE to the original predicate kit.
Sensitivity/ Specificity Testing:
Serum samples confirmed as positive or negative for antibodies to E. histolytica were tested by the device. Sensitivity and specificity values were calculated and compared with sensitivity/ specificity values for the original 510(k) kit. Substantial equivalency was validated by the testing.
Performance Sensitivity/ Specificity Data:
| Original 510(k) Test Kit
ASK Abstract C 38 Data: | Modified Test Kit
Comparison Data for Bench Study: | | | | | | |
|-----------------------------------------------------|-------------------------------------------------------|---------------------------------|-----------------------------|--------|---------|--------|-------------------------|
| Pos. / Neg. | TREND ELISA
Pos. / Neg. | Competitor ELISA
Pos. / Neg. | | | | | |
| Pos. (64)
Neg. (104)
168 | 6
3 | 13
101 | Pos. (8)
Neg. (49)
57 | 8
4 | 0
45 | 7
5 | 0(1 N.D.)
43(1 N.D.) |
| Sensitivity = 95%
Specificity = 97% | Sensitivity = 100%
Specificity = 92% | 100%
90% | | | | | |
Additional Testing:
Further bench studies validated substantial equivalency in the following identified parameters:
-- Testing for "visual" interpretation was performed.
--Testing for Intra-assay (Mith-in) Run Precision was performed.
--Testing for Run-to-Run Precision was performed.
--Testing for Cross-reactivity
SUBSTANTIALLY EQUIVALENCY CONCLUSIONS:
The above provided information validates that the modified kit presented is substantially equivalent to the original 510(k) kit.
-The Intended Use of the kit has not been changed. -Scientific Principle / Technology has not been changed. -Performance Data, as presented, validates that the performance sensitivity and specificity is equivalent.
############################################################################################################################################################################# 조 등 등 위 및 프로그 프로그 후 로 포 로 프
Prepared by
ed by: Syhira W. Muls
Sylvia W. Mills
Title: Immunology Manager
Date: 7/24/96