(275 days)
Xpect™ Giardia Lateral Flow Assay, K031942
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No
The device description details a standard lateral flow immunoassay which relies on chemical reactions and visual interpretation of lines, with no mention of computational analysis or algorithms.
No
This device is an in vitro diagnostic (IVD) test kit used for detecting Giardia antigens in fecal specimens to aid in the diagnosis of suspected Giardia infections. It does not provide any treatment or therapeutic benefit.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "This test is indicated as an aid in the clinical laboratory diagnosis of suspected Giardia infections. For in vitro diagnostic use." This clearly defines the device's role in diagnosing a medical condition.
No
The device description clearly outlines a physical lateral flow immunoassay kit with components like a dilution tube, buffer solution, sample well, membrane, and test/control lines that produce visible bands. This is a hardware-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use."
- Intended Use: The device is intended for the "detection of Giardia antigens in preserved and unpreserved human fecal specimens" as an "aid in the clinical laboratory diagnosis of suspected Giardia infections." This is a classic definition of an in vitro diagnostic test, as it analyzes a biological sample outside of the body to provide information for diagnosis.
- Device Description: The description details an "immunochromatographic assay" that detects an antigen in a human sample using antibodies, which is a common method for IVD tests.
- Intended User / Care Setting: The intended user is the "clinical laboratory," which is where IVD tests are typically performed.
N/A
Intended Use / Indications for Use
The IVD Research, Inc. Giardia Fecal Antigen Detection Lateral Flow Kit is a qualitative immunoassay for the detection of Giardia antigens in preserved and unpreserved human fecal specimens. This test is indicated as an aid in the clinical laboratory diagnosis of suspected Giardia infections. For in vitro diagnostic use.
Product codes
MHI
Device Description
The IVD Research, Inc. Giardia Fecal Antigen Detection Lateral Flow Kit is an immunochromatographic assay for the detection of Giardia lamblia antigen in human fecal samples. The test uses sample wicking to capture Giardia antigen on a discrete test line containing antibodies specific for Giardia antigen. A specimen is added to a dilution tube and mixed with a buffer solution. The mixture is dispensed into the sample well of the device which resolubilizes the Giardia specific mouse monoclonal antibody that has been conjugated to colored microparticles. This solution wicks along a membrane containing capture antibodies bound to the membrane at the Test and Control lines. The Giardia immune complex, if present, reacts with antibody at the Test line. Unbound conjugate not captured at the test line is captured at the Control line containing anti-mouse antibody. If Giardia antigens are present in the fecal sample, two pink-to-purple bands (one at the Sample line and one at the Control line) will appear in the test window. If no Giardia antigen is present, or if the level of antigen is below the detection limit of the assay, only one pink-to-purple band at the Control line will appear in the test window. For the test to be valid, a pink-to-purple band must always appear at the Control line position of the device test window regardless of whether the sample is positive or negative. This Control line indicates that the test is working properly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratory (implied)
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Reproducibility: Testing was performed at three sites (one internal; two external) using a masked panel of ten samples of varying reactivity tested over three days along with positive and negative controls. All samples tested for Giardia produced the expected result, summarizing to 100% reproducibility for both positive (54 tests) and negative (36 tests) samples.
Analytical Sensitivity: Determined by diluting cultured Giardia lamblia (WB strain) in negative human stool. Test results determined the limit of detection for the device to be 20 ng/ml.
Analytical Specificity/cross-reactivity/interfering substances: No cross-reactivity observed with various organisms (e.g., Entamoeba hartmanni, Blastocystis hominis, Cryptosporidium, rotavirus, 22 bacterial species). Six common microorganisms spiked into preserved positive and negative fecal specimens did not affect the test result. Blood, mucin, or Imodium® spiked into human feces samples did not interfere with the test.
Unpreserved Fecal Specimens Performance: Verified using 42 unpreserved samples, 15 positive and 27 negative, determined by Giardia lamblia Antigen Detection Microwell ELISA.
Sensitivity: 100% (95% CI = 78.2% to 100%)
Specificity: 100% (95% CI = 87.2% to 100%)
Clinical performance: Retrospective studies using well-characterized, archived samples. Performance relative to patients' clinical status has not been established.
1. Sensitivity and Specificity Compared to Microscopy or Direct Immunofluorescence Assay: Evaluated using 210 human fecal specimens collected in 10% formalin or SAF.
Sensitivity: 97.2% (106/109) 95% CI = 92.2% to 99.4%
Specificity: 96% (97/101) 95% CI = 90.2% to 98.9%
Four false positive specimens identified were re-tested using direct immunofluorescence assay and shown to be positive.
2. Percent Agreement vs. Predicate Device:
Positive Agreement: 98% (48/49)
Negative Agreement: 100% (61/61)
The results demonstrate substantial equivalence in performance to the predicate device and to microscopic examination for Giardia detection in human fecal specimens.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Unpreserved Fecal Specimens:
Sensitivity: 100% 95% CI = 78.2% to 100%
Specificity: 100% 95% CI = 87.2% to 100%
Clinical Performance (Compared to Microscopy or Direct Immunofluorescence Assay):
Sensitivity: 97.2% (106/109) 95% CI = 92.2% to 99.4%
Specificity: 96% (97/101) 95% CI = 90.2% to 98.9%
Percent Agreement vs. Predicate Device:
Positive Agreement 98% (48/49)
Negative Agreement 100% (61/61)
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.
Xpect™ Giardia Lateral Flow Assay, K031942
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.
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IVD Research, Inc. Premarket Notification 510(k) - Giardia Fecal Antigen Detection Lateral Flow Kit
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510(k) Summary
Section 5 Page 1 of 6
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IVD Research, Inc. Premarket Notification 510(k) - Giardia Fecal Antigen Detection Lateral Flow Kit
510(k) Summary
This 510(k) summary is submitted in accordance with 21 CFR §807.92.
| Owner: | IVD Research, Inc.
5909 Sea Lion Place, Suite D
Carlsbad, CA 92010 USA
Telephone: 760-929-7744; Fax 760-431-7759
Contact: Dave Lambillotte, President |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared: | April 12, 2008 |
| Trade name: | IVD Research, Inc. Giardia Fecal Antigen Detection
Lateral Flow Kit |
| Common name: | Giardia Fecal Antigen Detection Lateral Flow Kit |
| Classification name: | Entamoeba histolytica serological reagents
(21 CFR §866.3220; Product Code: MHI) |
| Predicate device: | Xpect™ Giardia Lateral Flow Assay, K031942 |
Device description:
The IVD Research, Inc. Giardia Fecal Antigen Detection Lateral Flow Kit is an immunochromatographic assay for the detection of Giardia lamblia antigen in human fecal samples. The test uses sample wicking to capture Giardia antigen on a discrete test line containing antibodies specific for Giardia antigen. A specimen is added to a dilution tube and mixed with a buffer solution. The mixture is dispensed into the sample well of the device which resolubilizes the Giardia specific mouse monoclonal antibody that has been conjugated to colored microparticles. This solution wicks along a membrane containing capture antibodies bound to the membrane at the Test and Control lines. The Giardia immune complex, if present, reacts with antibody at the Test line. Unbound conjugate not captured at the test line is captured at the Control line containing anti-mouse antibody. If Giardia antigens are present in the fecal sample, two pink-topurple bands (one at the Sample line and one at the Control line) will appear in the test window. If no Giardia antigen is present, or if the level of antigen is below the detection limit of the assay, only one pink-to-purple band at the Control line will appear in the test window. For the test to be valid, a pink-to-purple band must always appear at the Control line position of the device test window regardless of whether the sample is positive or negative. This Control line indicates that the test is working properly.
2
Intended use:
The IVD Research, Inc. Giardia Fecal Antigen Detection Lateral Flow Kit is a qualitative immunoassay for the detection of Giardia antigens in preserved and unpreserved human fecal specimens. This test is indicated as an aid in the clinical laboratory diagnosis of suspected Giardia infections.
Comparison with the predicate device:
The technological characteristics of the IVD Research Inc. Giardia Fecal Antigen Detection Lateral Flow Kit are compared with the Xpect™ Giardia Lateral Flow Assay (K031942) in the table below. This comparison demonstrates the substantial equivalence of this device to the predicate device. The devices are similar in intended use, assay technology and materials used to construct the test strip, and both devices use the same Giardia specific monoclonal antibodies for the conjugate. Both devices have similar clinical performance. Differences between the two devices in the sample size and materials used in the membrane are minimal.
| Item | IVD Research, Inc. Giardia Fecal
Antigen Detection Lateral Flow Kit
(Device) | Xpect™ Giardia Lateral Flow Assay
(K031942)
(Predicate) |
|------------------------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| | Similarities | |
| Intended Use | Detection of Giardia antigens in
fecal specimens. | Detection of Giardia antigens in fecal
specimens. |
| Technology | Qualitative immunochromatographic
assay. | Qualitative immunochromatographic
assay. |
| Capture antibodies or
molecules | Rabbit anti-Giardia and goat anti-
mouse IgG. | Rabbit anti-Giardia and goat anti-
mouse IgG. |
| Material: Membrane | Mylar-backed nitrocellulose. | Mylar-backed nitrocellulose. |
| | Differences | |
| Antibodies: Conjugate | Monoclonal anti-Giardia. | Monoclonal anti-Giardia and normal
mouse IgG. |
| Material: Conjugate | Colloidal gold labeled monoclonal
antibody to Giardia. | Anti-Giardia and mouse IgG colored
polystyrene particles diluted in buffer. |
| Specimen Type | Human stool preserved in 10%
formalin or SAF. | Human stool preserved in 10%
formalin, SAF or Cary Blair. |
| Sample Volume | 50 uL | 100 uL |
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Reproducibility:
Reproducibility testing was performed at three sites (one internal; two external) using a masked panel of ten samples of varying reactivity tested over three days along with positive and negative contols. All samples tested for Giardia produced the expected result, as summarized in the table below.
| | No. Positive
samples tested | No. Negative
samples tested | Total results | | Percent
Reproducibility
Obtained |
|---------------------------------------------|--------------------------------|--------------------------------|--------------------|--------------------|----------------------------------------|
| Number of tests
(sites x test occasions) | | | Number
Expected | Number
Obtained | |
| 9 | 6 | | 54 | 54 | 100 |
| 9 | | 4 | 36 | 36 | 100 |
Analytical Sensitivity:
Analytical sensitivity was determined by diluting cultured Giardia lamblia (WB strain) in negative human stool and testing across an antigen concentration range of 2.5 ng/mL to 80 ng/mL. Test results determined the limit of detection for the device to be 20 ng/ml.
Analytical Specificity/cross-reactivity/interfering substances:
No cross-reactivity was observed using samples containing the following organisms: Entamoeba hartmanni, Endolimax nana, Entamoeba histolytica/dispar, Entamoeba coli, Blastocystis hominis, Dientamoeba fragilis, Chilomastix mesnili, Cyclospora cavetanensis. Strongyloides stercoralis, Cryptosporidium, Ascaris lumbricoides, Enterobius vermicularis. Diphyllobothrium species. Hymenolepis nana, Clonorchis sinensis. Enteromonas hominis, Trichuris trichiura, Iodamoeba buetschlii, Schistosoma mansoni, rotavirus, Taenia eggs, Fasciola eggs, Isospora belli, adenovirus, rotavirus and twenty-two (22) bacterial species (Salmonella typhimurium, Proteus vulgaris, E. coli 43887, Campylobacter coli, Salmonella enteritidis, Campylobacter fetus, Staphylococcus aureus. Pseudomonas aeruginosa, Klebsiella pneumoniae, Serratia liquefaciens, Enterobacter cloacae, Citrobacter braakii, Shigella flexneri, Shigella sonneii, Shigella dysenteria, E. hermanii, Campylobacter jejuni, Salmonella hadar, Salmonella infantis, Yersinia enterocolitica, Enterococcus fecalis, Helicobacter cinaedi). Additionally, six common microorganisms (Campylobacter coli, E. coli, Salmonella enteritidis, Shigella flexneri, Campylobacter jejuni, Yersinia enetrocolitica) spiked into preserved positive and negative fecal specimens did not affect the test result.
Human feces samples positive and negative for Giardia antigen were spiked with blood, mucin, or Imodium® prior to testing with the Giardia Fecal Antigen Detection Lateral Flow Kit. Testing indicated that none of these substances interfered with the test.
Specimen stability:
Assay performance in preserved specimen types claimed in the labeling was verified during assay development using specimens from an internal QC bank as follows: fifteen positive samples preserved in either 10% formalin or sodium acetate-acetic acid-formalin
Section 5 Page 4 of 6
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IVD Research, Inc. Premarket Notification 510(k) - Giardia Fecal Antigen Detection Lateral Flow Kit
(SAF) with a maximum age of 7 years; twenty-three 10% formalin/SAF negative samples (maximum age 18 months); three fresh-frozen, un-preserved samples (2 positive; 1 negative) approximately 10 years old which had undergone numerous freeze/thaw cycles; and eleven fresh negative samples that had undergone three freeze/thaw cycles. All samples gave the expected result when tested according to the assay procedure.
Unpreserved Fecal Specimens
Assay performance in unpreserved specimens was verified using a total of 42 unpreserved samples fecal samples that were positive for antigens of Giardia lamblia as determined by a non-lateral flow methodology (Giardia lamblia Antigen Detection Microwell ELISA, IVD Research, Inc.). Fifteen of these samples tested positive in the ELISA test and 27 tested negative in the ELISA. All 15 of the positive samples and 20 of the negative samples were part of IVD Research's frozen sample bank and are stored at -15℃ or lower.
The results summarized below demonstrate that the IVD Research Giardia Fecal Antigen Detection Lateral Flow Kit produces acceptable test results when samples are unpreserved.
| ELISA + | ELISA - | |
|---|---|---|
| LF + | 15 | 0 |
| LF - | 0 | 27 |
Sensitivity: 100% 95% CI = 78.2% to 100% Specificity: 100% 95% CI = 87.2% to 100%
Specimen collection/preparation/stability:
Fresh, unpreserved stool samples should be stored at 2℃ - 8℃ and tested within 24 hours of collection. Samples that cannot be tested within this time should be frozen at -15°C to -25°C until use.
Stool specimens preserved in 10% formalin or SAF may be kept at room temperature (15℃ - 25℃) and tested within 18 months of collection.
Do not freeze preserved specimens.
Do not concentrate stool specimens. The assay will not give accurate results on a concentrated sample.
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Clinical performance:
The performance of the Giardia Fecal Antigen Detection Lateral Flow Kit was determined in retrospective studies using well-characterized, archived samples. Performance relative to patients' clinical status has not been established.
1. Sensitivity and Specificity Compared to Microscopy or Direct Immunofluorescence Assay
Clinical performance was evaluated using a total of 210 human fecal specimens collected in 10% formalin or SAF and submitted to an independent laboratory for testing with the Giardia Fecal Antigen Detection Lateral Flow Kit. The following results were obtained.
| Ref + | Ref - | |
|---|---|---|
| LF + | 106 | 4 |
| LF - | 3 | 97 |
Sensitivity: 97.2% (106/109) 95% CI = 92,2% to 99.4% Specificity: 96% (97/101) 95% CI = 90.2% to 98.9%
Four "negative" specimens gave a false positive result when tested with the Giardia LF test. These samples were re-tested using a direct immunofluorescence assay and shown to be positive.
2. Percent Agreement vs. Predicate Device
The Percent Agreement of the IVD Research, Inc. Giardia Fecal Antigen Detection Lateral Flow Kit versus the predicate device was as follows:
| Remel Xpect® | Remel Xpect® | |
|---|---|---|
| LF + | 48 | 0 |
| LF - | 1 | 61 |
98% (48/49) Positive Agreement Negative Agreement 100% (61/61)
The results of the bench and clinical performance testing demonstrate that the IVD Research Inc., Giardia Fecal Antigen Detection Lateral Flow Kit is substantially equivalent in performance to the predicate device and to microscopic examination for the detection of Giardia in human fecal specimens.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three legs, representing the department's mission to protect the health of all Americans and provide essential human services. The seal is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The image is in black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
IVD Research, Inc. c/o Mr. Michael Wienholt Regulatory Consulting, LLC 5470 E. Edwin Road Tucson. AZ 85739
JAN 1 4 2009
Re: K081064
Trade/Device Name: Giardia Fecal Antigen Detection Lateral Flow Kit Regulation Number: 21 CFR 866.3220 Regulation Name: Entamoeba histolytica serological reagents. Regulatory Class: Class II Product Code: MHI Dated: December 30, 2008 Received: December 31, 2008
Dear Mr. Wienholt:
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 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 Form
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
Indications for Use Statement
510(k) Number (if known): K081064
Giardia Fecal Antigen Detection Lateral Flow Kit Device Name:
Indications for Use:
The IVD Research, Inc. Giardia Fecal Antigen Detection Lateral Flow Kit is a qualitative immunoassay for the detection of Giardia antigens in preserved and unpreserved human fecal specimens. This test is indicated as an aid in the clinical laboratory diagnosis of suspected Giardia infections. For in vitro diagnostic use.
Prescription Use V (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
:
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Andrew Stone
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081064