(204 days)
Not Found (No K/DEN number provided for predicate device)
Not Found
No
The device description details a standard ELISA assay, which is a biochemical test. There is no mention of AI/ML in the device description, intended use, or performance studies. The analysis is based on chemical reactions and spectrophotometric or visual reading, not algorithmic interpretation of complex data.
No.
The device is a diagnostic test kit used to detect Cryptosporidium antigen in feces, which aids in the detection of infection, but it does not treat or cure a disease.
Yes
The intended use explicitly states the device is for the "qualitative determination Cryptosporidium antigen in feces" to "aid in the detection of Cryptosporidium gastrointestinal to infection," which describes a diagnostic purpose. The "Device Description" explains how the test works to identify these antigens, and the "Intended User / Care Setting" is "Diagnostic laboratories."
No
The device description clearly outlines a physical ELISA test kit involving microplate wells, antibodies, enzymes, and colorimetric reactions, which are all hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the qualitative determination Cryptosporidium antigen in feces." This is a diagnostic test performed on a biological sample (feces) in vitro (outside the body) to aid in the detection of a gastrointestinal infection.
- Device Description: The description details an "antigen capture enzyme linked immunosorbent assay (ELISA) for use with stools/ fecal material." ELISA is a common in vitro diagnostic technique.
- Anatomical Site: The sample is feces, which is a biological specimen collected from the body for analysis.
- Intended User / Care Setting: The intended users are "Diagnostic laboratories," which are the typical settings for performing in vitro diagnostic tests.
- Performance Studies: The document describes clinical laboratory bench studies using fecal samples to evaluate the device's performance (sensitivity and specificity), which is standard practice for validating IVDs.
All of these elements 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 determination Cryptosporidium antigen in feces. The ELISA test kit is of indicated for use with fecal specimens from patient's with diarrhea aid in the detection of Cryptosporidium gastrointestinal to infection.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The device is an antigen capture enzyme linked immunosorbent assay (ELISA) for use with stools/ fecal material. The antigen capture takes place in microplate wells. During the first incubation, Cryptosporidium antigens present in the stool supernatant are captured by antibodies attached to the test wells. The second incubation adds an additional anti-Cryptosporidium antibody that "sandwiches" the antigen. The next incubation identifies the antibody/ antigen complex and amplifies the signal by the addition of an anti-immunoglobulin antibody conjugated to horse radish peroxidase (HRP). After washings that remove unbound enzyme, a substrate is added which develops a blue color in the presence of the enzyme complex. The stop solution ends the reaction and turns the blue color to yellow. The results may be read spectrophotometrically with a microplate reader or visually.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Laboratory Bench Studies were performed in-house and at two off-site locations, a parasitology reference laboratory with a high incidence of immunocompromised patients and a university research center, to validate SUBSTANTIAL EQUIVALENCE of the device.
Fecal samples known to be positive or negative for Cryptosporidium parvum by conventional microscopy with modified acid fast (MAF) staining were tested. Sensitivity / Specificity values were calculated and compared with the Sensitivity/ Specificity values for the referenced predicate device. Substantial equivalency was validated by the testing.
Additional Testing: Further bench studies validated performance equivalency in the parallel studies using referenced specimen preparations and "types". Testing of known parasite positive fecal specimens was performed to validate specificity/ freedom from cross reactivity. No cross reactivity was seen with any of the parasitic samples tested. No cross reactivity was seen with any of the following fecal source microorganisms: Pathogenic Enteric Bacteria, Fungi, Virus. Testing to determine Analytical Sensitivity of the Test System was performed. The sensitivity was determined to be approximately 4.6 ng/ml. of Cryptosporidium antigen. Testing for Precision and Reproducibility was performed at three off-site locations.
Key Results:
Reference Data for Predicate Kit:
Study #1: Sensitivity: 97%, Specificity: 100%, Microscopy + = 134, Microscopy - = 78, Study Base: 212
Study #2: (Resolved) Sensitivity: 97%, Specificity: 98%, Microscopy + = 35, Microscopy - = 343, Study Base: 378
TREND Cryptosporidium Performance Data:
Study A: Sensitivity: 96.2%, Specificity: 97.1%, Microscopy + = 26, Microscopy - = 70, Study Base: 96
Study B: Sensitivity: 97%, Specificity: 100 %, Microscopy + = 68, Microscopy - = 29, Study Base: 97
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity, Specificity
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.
Not Found (No K/DEN number provided for predicate device)
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
§ 866.3220
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
JU 11 1996
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ﻤﺴﺴﺴﺴﺴﺴﺴ
- Summary of 510(k) Safety and Bffectiveness information. Trade / Proprietary Name: TRBND Cryptosporidium Direct Detection
Test System, Cat.4 BA49-
DESCRIPTION and INTENDED USE of the DEVICE:
The intended use of the device is for the qualitative determination Cryptosporidium antigen in feces. The ELISA test kit is of indicated for use with fecal specimens from patient's with diarrhea aid in the detection of Cryptosporidium gastrointestinal to infection.
Traditional detection of parasitic organisms has been conventional microscopic examination of fecal material. During the last few vears. ELISA technology for the identification of specific parasites has become more common and cost effective for many laboratories.
Cryptosporidium parvum is a coccidian parasite recognized as a human and animal pathogen. Symptoms of a parasitemia caused by this organism include diarrhea, nausea, low grade fever, abdominal cramps, and anorexia. The organism is a common cause of selflimiting diarrhea in immunocompetent persons and may cause a chronic, severe, and life-threatening diarrhea in immunocompromised patients, particularly those with HIV. Transmission modes include person-to-person or animal-to-person contact with fecal material and contact with contaminated food or water supplies.
SCIENTIFIC PRINCIPLES:
The device is an antigen capture enzyme linked immunosorbent assay (ELISA) for use with stools/ fecal material. The antigen capture takes place in microplate wells. During the first incubation, Cryptosporidium antigens present in the stool supernatant are captured by antibodies attached to the test wells. The second incubation adds an additional anti-Cryptosporidium antibody that "sandwiches" the antigen. The next incubation identifies the antibody/ antigen complex and amplifies the signal by the addition of an anti-immunoglobulin antibody conjugated to horse radish peroxidase (HRP). After washings that remove unbound enzyme, a substrate is added which develops a blue color in the presence of the enzyme complex. The stop solution ends the reaction and turns the blue color to yellow. The results may be read spectrophotometrically with a microplate reader or visually.
TECHNOLOGY:
ﺳﯩﻤﻪ
The ELISA technology of the device, as defined in the Scientific Principles section above, is utilized in a number of in vitro diagnostic test kits currently used in diagnostic laboratories. ELISA kits specific for the detection of other parasitic organisms (for example, Giardia lamblia) are also being used. છે 4 તે ર
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Page 3 of 4
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Summary of 510(k) Safety and Bffectiveness information. TREAD Cryptosporidium Direct Detection Trade / Proprietary Mane:
Test System, Cat. # BA49-
PERFORMANCE TESTING:
Clinical Laboratory Bench Studies were performed in-house and at two off-site locations, a parasitology reference laboratory with a high incidence of immunocompromised patients and a university research center, to validate SUBSTANTIAL EQUIVALENCE of the device.
Fecal samples known to be positive or negative for Cryptosporidium parvum by conventional microscopy with modified acid fast (MAF) staining were tested. Sensitivity / Specificity values were calculated and compared with the Sensitivity/ Specificity values for the referenced predicate device. Substantial equivalency was validated by the testing.
Reference Data for Predicate Kit:
| Study #1: | Study #2: (Resolved) | ||
|---|---|---|---|
| Sensitivity: | 97% | Sensitivity: | 97% |
| Specificity: | 100% | Specificity: | 98% |
| Microscopy + = | 134 | Microscopy + = | 35 |
| Microscopy - = | 78 | Microscopy - = | 343 |
| Study Base: | 212 | Study Base: | 378 |
TREND Cryptosporidium Performance Data:
| Study A: | Study B: | ||
|---|---|---|---|
| Sensitivity: 96.2% | Sensitivity: 97% | ||
| Specificity: 97.1% | Specificity: 100 % | ||
| Microscopy + = 26 | Microscopy + = 68 | ||
| Microscopy - = 70 | Microscopy - = 29 | ||
| Study Base: 96 | Study Base: 97 |
0496
2
Summary of 510(k) Safety and Effectiveness information. Page 4 of 4 TREND Cryptosporidium Direct Detection Trade / Proprietary Wame: Test System, Cat.4 BA49-Additional Testing: Further bench studies validated performance equivalency in the
Parallel studies were performed using referenced specimen -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------preparations and "types".
- Testing of known parasite positive fecal specimens was - performed to validate specificity/ freedom from cross reactivity. No cross reactivity was seen with any of the parasitic samples tested. Following is a list of the tested parasitic organisms:
| Ascaris lumbricoides
Cyclospora spp.
Entamoeba coli
Endolimax nana
Hymenolepis nana
Paragonimus westeri.
Trichomonis hominis | Blastocystis hominis
Dientamoeba fragilis
Entamoeba hartmanni
Fasciola hepatica
Iodamoeba butschlii
Strongyloides sterc.
Hookworm | Chilomastix mesnili
Diphyllobothrium latum
Entamoeba histolytica
Giardia lamblia
Isospora belli
Taenia spp. | Clonorchis sinensis
Eimeria spp.
Entamoeba polecki
Hymenolepis diminuta
Microsporidia spp.
Trichuris trichiura |
| ------------------------------------------------------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------- |
|---|
No cross reactivity was seen with any of the following fecal source microorganisms:
Pathogenic Enteric Bacteria: Fungi: Candida albicans Campylobacter jejuni Escherichia coli Cryptococcus neoformans Salmonella typhimurium Virus: Shigella flexneri Rotavirus
- Testing to determine Analytical Sensitivity of the Test System - -The sensitivity was determined to performed. be was approximately 4.6 ng/ml. of Cryptosporidium antigen.
- Testing for Precision and Reproducibility was performed at l
i three off-site locations.
SUBSTANTIALLY EQUIVALENCY CONCLUSIONS:
following parameters:
The above provided information validates that the TREND device is substantially equivalent to the referenced predicate kit.
-The Intended Use of the kit is the same. -Scientific Principle / Technology is the same. -Performance Data. as presented, validates that the performance (Sensitivity /Specificity) is equivalent. -Analytical Sensitivity of the device is equivalent.
છે 4 9 દ 8% 제 제 제 로 로 고 있 제 제 8% 2 区区北北京区区区区区区区区区区域区北京市区区区区区市市区区区区区区区区区区区区区区区 ware Title: Director of Quality Prepared by: Control Mariellyn Truax, MT(ASCP) Date: