(127 days)
No
The device description and performance studies focus on a traditional enzyme immunoassay method using antibodies and color detection, with no mention of AI or ML technologies.
No.
The device is for diagnostic purposes (detecting antigens) and does not provide therapy or treatment.
Yes
The 'Intended Use / Indications for Use' section states that the device "is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Giardia and/or Cryptosporidium gastrointestinal infections."
No
The device description clearly outlines a laboratory-based enzyme immunoassay kit involving physical reagents, microassay plates, and washing steps, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for the "qualitative detection of Giardia cyst and Cryptosporidium oocyst antigen in human fecal specimens" and is "indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Giardia and/or Cryptosporidium gastrointestinal infections." This clearly describes a test performed in vitro (outside the body) on a human specimen for diagnostic purposes.
- Device Description: The description details an "enzyme immunoassay" performed on a "diluted fecal specimen" using antibodies and a microassay plate. This is a standard laboratory technique for in vitro testing.
- Anatomical Site: The test is performed on "Fecal specimens," which are collected from the human body but tested in vitro.
- Performance Studies: The performance studies involve testing human clinical samples and comparing the results to other in vitro diagnostic methods (ELISA and microscopy).
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GIARDIA/CRYPTOSPORIDIUM CHEK™ test is an enzyme immunoassay for the qualitative detection of Giardia cyst and Cryptosporidium oocyst antigen in buman fer al specimens. It is indicated for use as an aid in the diagnosis of patients with diaman tour .
Clearly and and and Giardia and/or Cryptosporidium gastrointestinal infections.
Product codes
MHI, MHJ
Device Description
The GIARDIA/CRYPTOSPORIDIUM CHEK™ test uses monoclonal and polyclonal antibodies to cell-surface antigens of Giardia and an oocyst antigen of Cryptosporidium. The Microassay Plate in the kit contains immobilized monoclonal antibodies against the antigens and the Conjugate consists of polyclonal antibodies against the antigens. In the assay, an aliquot of a diluted fecal specimen is transferred to a microassay well. The immobilized monoclonal antibodies bind the Giardia and Cryptosporidium antigens if the antigens are present. Upon addition, Conjugate then binds to the antigen/antibody complex. Any unbound materials are removed during the washing steps. Following the addition of substrate, a color is detected due to the enzyme-antibody-antigen complexes that formed in the presence of Giardia or Cryptosporidium antigens and Conjugate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human fecal specimens
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
Summary of Clinical Evaluations:
- Two studies were performed.
- Study 1: Comparison of the GIARDIA/CRYPTOSPORIDIUM CHEK™ test to a commercially available ELISA (ProSpecT® Giardia/Cryptosporidium Microplate Assay).
- Sample size: n = 590
- Key Results:
- Percent Agreement - Positive Specimens: 98.6% (95% Confidence Interval: 96.2% - 99.6%)
- Percent Agreement - Negative Specimens: 98.7% (95% Confidence Interval: 96.4% - 99.6%)
- Percent Agreement - Overall: 98.6% (95% Confidence Interval: 98.4% - 98.8%)
- Study 2: Comparison of the GIARDIA/CRYPTOSPORIDIUM CHEK™ test to IFA-confirmed microscopy results from Site 1.
- Sample size: n = 217
- Key Results:
- Sensitivity: 97.6% (95% Confidence Interval: 92.6% - 99.4%)
- Specificity: 100% (95% Confidence Interval: 95.1% - 100%)
- Predictive Positive Value: 100% (95% Confidence Interval: 96.2% - 100%)
- Predictive Negative Value: 96.9% (95% Confidence Interval: 90.5% - 99.2%)
- Correlation: 98.6% (95% Confidence Interval: 98.2% - 98.9%)
Reproducibility:
- Study type: Multi-site proficiency testing.
- Sample size: 24 samples (eight Giardia-positive, eight Cryptosporidium-positive, eight negative).
- Data source: Fecal panel assembled and tested at TECHLAB®, Inc. and two independent laboratories.
- Annotation protocol: Each sample was tested during three independent trials over a three-day period.
- Key results: Demonstrated 100% correlation for all samples from all three testing sites.
Sensitivity (Analytical):
- Study type: Sensitivity to antigen preparation.
- Sample size: 6 separate trials, using three different lots.
- Key results: Consistently positive at 375 Giardia cysts/mL, 0.8 ng recombinant cyst wall protein/mL, and 6250 Cryptosporidium oocysts/mL.
Specificity (Crossreactivity):
- Study type: Evaluation with fecal specimens positive for various intestinal pathogens, bacterial and viral strains.
- Data source: Independent diagnostics laboratory.
- Key results: No cross reactivity observed with any of the tested pathogens, bacterial strains, or viral strains.
Interfering Substances:
- Study type: Evaluation of the effect of common substances on test results.
- Key results: Mucin, human blood, Imodium®, Kaopectate®, Pepto-Bismol®, fecal fat (stearic acid), Metronidazole, and Vancomycin had no effect on positive or negative test results at the concentrations indicated.
Key Metrics
- Percent Agreement - Positive Specimens: 98.6%
- Percent Agreement - Negative Specimens: 98.7%
- Percent Agreement - Overall: 98.6%
- Sensitivity: 97.6%
- Specificity: 100%
- Predictive Positive Value: 100%
- Predictive Negative Value: 96.9%
- Correlation: 98.6%
Predicate Device(s)
Reference Device(s)
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
7. 510(k) SUMMARY
NOV 1 7 2005
| Contact Information | David M. Lyerly
Vice-President, Research & Development
TECHLAB®, Inc.
2001 Kraft Drive
Corporate Research Center
Blacksburg, VA 24060-6364
Phone: 540-953-1664
FAX: 540-953-1665
Email: dlyerly@techlab.com | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Date Prepared | July 12, 2005 | |
| Product and Trade Name | GIARDIA/CRYPTOSPORIDIUM CHEKTM | |
| Classification | Giardia spp.
21 CFR 866.3220 | Product Code: MHI |
| | Cryptosporidium spp.
21 CFR 866.3220 | Product Code: MHJ |
| Predicate Devices | ProSpecT® Giardia/Cryptosporidium Microplate Assay
Remel (Lenexa, KS - formerly Alexon Biomedical, Inc.)
K955157
MerifluorTM Cryptosporidium / Giardia Kit
Meridian Diagnostics (Cincinnati, Ohio) | |
Intended Use
The GIARDIA/CRYPTOSPORIDIUM CHEK™ test is an enzyme immunoassay for the qualitative detection of Giardia cyst and Cryptosporidium oocyst antigen in buman fer al specimens. It is indicated for use as an aid in the diagnosis of patients with diaman tour .
Clearly and and and Giardia and/or Cryptosporidium gastrointestinal infections.
1
Device Description
The GIARDIA/CRYPTOSPORIDIUM CHEK™ test uses monoclonal and polyclonal antibodies to cell-surface antigens of Giardia and an oocyst antigen of Cryptosporidium. The Microassay Plate in the kit contains immobilized monoclonal antibodies against the antigens and the Conjugate consists of polyclonal antibodies against the antigens. In the assay, an aliquot of a diluted fecal specimen is transferred to a microassay well. The immobilized monoclonal antibodies bind the Giardia and Cryptosporidium antigens if the antigens are present. Upon addition, Conjugate then binds to the antigen/antibody complex. Any unbound materials are removed during the washing steps. Following the addition of substrate, a color is detected due to the enzyme-antibody-antigen complexes that formed in the presence of Giardia or Cryptosporidium antigens and Conjugate.
2
| Kit Name | 510(k)
Numbers | Intended Use | Format | Materials | Target
Population |
|-----------------------------------------------------------|---------------------------|----------------------------------------------------------------------------------------------|----------------------------------|-------------------------------------------------------------------------|------------------------------------------------------------------------------|
| GIARDIA/
CRYPTOSPORIDIUM
CHEKTM | Subject to
this 510(k) | Detection of
Giardia cyst and
Cryptosporidium
oocyst antigen in
fecal specimens | ELISA | Highly specific
antibodies against
Giardia and
Cryptosporidium | Persons suspected
of having Giardia
OT
Cryptosporidium
infection |
| Microscopy | N/A | Direct detection of
Giardia cysts and
Cryptosporidium
oocysts in fecal
specimens | Microscopy | Various Stains | Persons suspected
of having Giardia
or
Cryptosporidium
infection |
| ProSpecT® Giardia/
Cryptosporidium
Microplate Assay | K955157 | Detection of
Giardia cyst and
Cryptosporidium
oocyst antigen in
fecal specimens | ELISA | Highly specific
antibodies against
Giardia and
Cryptosporidium | Persons suspected
of having Giardia
or
Cryptosporidium
infection |
| Merifluor™
Cryptosporidium/
Giardia Kit | K912408 | Direct detection of
Giardia cysts and
Cryptosporidium
oocysts in fecal
specimens | DFA -
Immuno-
fluorescence | Highly specific
antibodies against
Giardia and
Cryptosporidium | Persons suspected
of having Giardia
Or
Cryptosporidium
infection |
7.1 Comparative Information of Equivalent Devices
3
7.2 Summary of Performance Data
Summary of Clinical Evaluations 7.2.1
Tables 1 and 2 display the comparison of the GIARDIA/CRYPTOSPORIDIUM CHEK™ test to a commercially available ELISA and to microscopy. Results are compiled from the three clinical study sites and include all samples used in the clinical evaluation of the test.
Table 1 displays the comparison of the GIARDIA/CRYPTOSPORIDIUM CHEK™ test to a commercially available ELISA and to microscopy from all three test sites. The results show that, compared to a commercially available ELISA, the GIARDIA/CRYPTOSPORIDIUM CHEK™ test exhibited 98.6% agreement for positive specimens, 98.7% agreement for negative specimens, and 98.6% agreement overall.
Table 2 displays the comparison of the GIARDIA/CRYPTOSPORIDIUM CHEK™ test to IFA-confirmed microscopy results from Site 1. The results show that, compared to microscopic analysis, the GIARDIA/CRYPTOSPORIDIUM CHEK™ test exhibited 97.6% sensitivity, 100% specificity, and 98.6% correlation.
| TABLE 1: SUMMARY OF ALL STUDIES
GIARDIA/CRYPTOSPORIDIUM CHEK™
Comparison to a commercially available ELISA
(n = 590) | ProSpecT® Giardia/Cryptosporidium
Microplate Assay | | | |
|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|----------|----------|-------|
| | | Positive | Negative | Total |
| GIARDIA/CRYPTOSPORIDIUM CHEK™ | Positive | 283 | 4 | 287 |
| TECHLAB®, Inc. | Negative | 4 | 299 | 303 |
| | Total | 287 | 303 | 590 |
| GIARDIA/CRYPTOSPORIDIUM CHEK™
vs. ProSpecT® Giardia/Cryptosporidium
Microplate Assay | Percent
Agreement | 95%
Confidence Interval |
|--------------------------------------------------------------------------------------------|----------------------|----------------------------|
| Percent Agreement - Positive Specimens | 98.6% | 96.2% - 99.6% |
| Percent Agreement - Negative Specimens | 98.7% | 96.4% - 99.6% |
| Percent Agreement - Overall | 98.6% | 98.4% - 98.8% |
4
| TABLE 2: SUMMARY OF ALL STUDIES
GIARDIA/CRYPTOSPORIDIUM CHEK™
| Comparison to Microscopy | Microscopy | |||
|---|---|---|---|---|
| (n = 217) | Positive | Negative | Total | |
| GIARDIA/CRYPTOSPORIDIUM CHEK™ | Positive | 121 | 0 | 121 |
| Negative | ಗೆ | ਹੈ ਤੇ | 96 | |
| Total | 124 | ਹੈਤੇ | 217 |
| GIARDIA/CRYPTOSPORIDIUM CHEKTM
vs. Microscopy | Result | 95%
Confidence Interval |
|--------------------------------------------------|--------|----------------------------|
| Sensitivity | 97.6% | 92.6% - 99.4% |
| Specificity | 100% | 95.1% - 100% |
| Predictive Positive Value | 100% | 96.2% - 100% |
| Predictive Negative Value | 96.9% | 90.5% - 99.2% |
| Correlation | 98.6% | 98.2% - 98.9% |
7.2.2 Reproducibility
Multi-site proficiency testing was conducted to establish the ability of the GIARDIA/CRYPTOSPORIDIUM CHEK™ test to provide reproducible results in laboratory settings. A fecal panel was assembled and tested at TECHLAB®, Inc. Identical aliquots of the panel were tested at TECHLAB®, Inc. and two independent laboratories using the GIARDIA/CRYPTOSPORIDIUM CHEK™ test. The fecal panel consisted of 24 samples: eight Giardia-positive samples, eight Cryptosporidium-positive samples, and eight samples negative for both parasites. Samples were selected that provided a range of absorbance values over the working range of the GIARDIA/CRYPTOSPORIDIUM CHEK™ test (OD450 reading 0.0 - 4.0), including positive samples close to the positive/negative cut-off absorbance (OD450 0.150). Each sample was tested during three independent trials over a three-day period. Proficiency testing demonstrated 100% correlation for all samples from all three testing sites.
7.2.3 Sensitivity
Sensitivity to each antigen preparation was evaluated in 6 separate trials, using three different lots of the GIARDIA/CRYPTOSPORIDIUM CHEK™ test. The GIARDIA/CRYPTOSPORIDIUM CHEK™ test was consistently positive at 375 Giardia cysts/mL, 0.8 ng recombinant cyst wall protein/mL, and 6250 Cryptosporidium oocysts/mL.
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7.2.4 Specificity
Crossreactivity
An independent diagnostics laboratory evaluated the GIARDIA/CRYPTOSPORIDIUM CHEK™ test using fecal specimens found to be positive for a variety of intestinal pathogens. No cross reactivity was observed with fecal specimens that contained any of the pathogens listed below. The number of specimens tested with each organism is shown in parentheses.
| Ascaris lumbricoides eggs (26) | Entamoeba coli (17) |
|---|---|
| Blastocystis hominis (31) | Entamoeba hartmanni (4) |
| Chilomastix mesnili (2) | Enterobius vermicularis eggs (6) |
| Cyclospora cayetanensis (1) | Hymenolepis nana eggs (4) |
| Dientamoeba fragilis (10) | Iodamoeba bütschlii (4) |
| Diphyllobothrium latum eggs (1) | Strongyloides stercoralis larvae (2) |
| Endolimax nana (36) | Taenia spp. eggs (2) |
| Entamoeba histolytica/dispar (9) | Trichuris trichiura eggs (20) |
The GIARDIA/CRYPTOSPORIDIUM CHEK™ test was evaluated for crossreactivity with the bacterial and viral strains listed below. None of the strains were shown to crossreact with the GIARDIA/CRYPTOSPORIDIUM CHEK™ test.
| Escherichia coli | Escherichia coli ETEC (enterotoxic) |
|---|---|
| Escherichia coli 0157H7 | Escherichia coli EPEC (enteropathogenic) |
| Yersinia enterocolitica | Escherichia coli EIEC (enteroinvasive) |
| Aeromonas hydrophila | Salmonella typhimurium |
| Shigella dysenteriae | Shigella flexneri |
| Salmonella typhimurium | Campylobacter coli |
| Campylobacter fetus | Clostridium difficile |
| Vibrio parahaemolyticus | Staphylococcus aureus (Cowan's) |
| Staphylococcus aureus | Staphylococcus epidermidis |
| Klebsiella pneumoniae | Enterococcus faecalis |
| Clostridium bifermentans | Bacteroides fragilis |
| Bacillus subtilis | Bacillus cereus |
| Adenovirus type 1 | Adenovirus type 2 |
| Adenovirus type 3 | Adenovirus type 5 |
| Adenovirus type 40 | Adenovirus type 41 |
| Human coronavirus | Coxsackievirus B2 |
| Coxsackievirus B3 | Coxsackievirus B4 |
| Coxsackievirus B5 | Echovirus 9 |
| Echovirus 11 | Echovirus 18 |
| Echovirus 22 | Echovirus 33 |
| Enterovirus type 68 | Enterovirus type 69 |
| Enterovirus type 70 | Enterovirus type 71 |
Interfering Substances
The following substances had no effect on positive or negative test results analyzed at the concentrations indicated: mucin (3.5% w/v), human blood (40% w/v), Imodium® (5% w/v), Kaopectate® (5 mg/mL), Pepto-Bismol® (5% w/v), fecal fat (stearic acid - 40% w/v), Metronidazole (0.25% w/v), Vancomycin (0.25% w/v).
6
Image /page/6/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" around the perimeter. Inside the circle is an abstract image of an eagle with three stylized lines representing its wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 7 2005
David M. Lverly, Ph.D. Vice President of Research and Development TECHLAB®, Inc. 2001 Kraft Drive Blacksburg, VA 24060-6358
K051929 Trade/Device Name: GIARDIA/CRYTOSPORIDIUM CHECK™ Regulation Number: 21 CFR 866.3220 Regulation Name: Entamoeba Histolytica Serological Reagents Regulatory Class: Class II Product Code: MHJ Dated: October 20, 2005 Received: October 25, 2005
Dear Dr. Lyerly:
Re:
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).
7
Page 2 -
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 information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Sale, a Hom
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
8
2. INDICATIONS FOR USE
510(k) Number (if known): K 051929
GIARDIA/CRYPTOSPORIDIUM CHEK™ Device Name:
Indications For Use:
The GIARDIA/CRYPTOSPORIDIUM CHEK™ test is an enzyme immunoassay for the qualitative detection of Giardia cyst and Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Giardia and/or Cryptosporidium gastrointestinal infections.
FOR IN VITRO DIAGNOSTIC USE.
Prescription Use v (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Luddi L. Poole
sion Sign-Off
Page 1 of 1
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K051929
11