(150 days)
(k)983399
Not Found
No
The device description details a lateral flow immunoassay, which is a chemical and physical process, not an AI/ML algorithm. There is no mention of AI, ML, or image processing in the summary.
No
This device is an in vitro diagnostic immunoassay used to detect antigens, aiding in the diagnosis of infections, not to provide therapy.
Yes.
The intended use statement explicitly states that the device is intended as an aid in the laboratory diagnosis of suspected Giardia and Cryptosporidium infections.
No
The device description clearly outlines a physical lateral flow assay kit that utilizes chemical reactions and a membrane for detection, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is an "in vitro qualitative immunoassay for the detection of Giardia and Cryptosporidium antigens in preserved and unpreserved fecal specimens." This clearly indicates the test is performed outside of the body using biological samples.
- Device Description: The description details a "chromatographic immunoassay" that detects antigens in a specimen. This is a common method used in IVD tests.
- Intended User / Care Setting: The intended user is a "Laboratory diagnosis," which is where IVD tests are typically performed.
- Performance Studies: The document describes performance studies evaluating sensitivity and specificity compared to microscopy and a predicate device. This type of evaluation is standard for IVD devices to demonstrate their accuracy and reliability.
- Predicate Device: The mention of a "Predicate Device" (K983399; Becton Dickinson ColorPAC™ Giardia/Cryptosporidium Rapid Assay) is a strong indicator that this device is being compared to an existing legally marketed IVD device for regulatory purposes.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
REMEL's Xpect™ Giardia/Cryptosporidium kit is an in vitro qualitative immunoassay for the detection of Giardia and Cryptosporidium antigens in preserved and unpreserved fecal specimens. This test is intended as an aid in the laboratory diagnosis of suspected Giardia and Cryptosporidium infections.
Product codes (comma separated list FDA assigned to the subject device)
MHI, MHJ
Device Description
The Xpect™ Giardia/Cryptosporidium Lateral Flow Assay is a chromatographic immunoassay that detects the presence of Giardia and Cryptosporidium antigens. The test utilizes sample wicking to capture Giardia and Cryptosporidium antigens on discrete test lines containing antigen-specific antibodies for each organism. A specimen is added to a dilution tube containing a buffered solution. A conjugate containing colored micro-particles linked to monoclonal antibodies specific for Giardia and Cryptosporidium is added. The mixture is dispensed into the sample well of the device and wicks across a membrane containing capture antibody stripes. The Giardia/Cryptosporidium immune complexes if present react with anti-Giardia antibody and/or anti-Cryptosporidium antibody at the test line. Conjugates not bound at the test lines are later captured at the control line containing anti-mouse antibody. A blue line will appear at the Giardia test position if Giardia antigen is present and a pink line will appear at the Cryptosporidium test position if Cryptosporidium antigen is present. A line in the Control position 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
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
The performance of the Xpect™ Giardia/Cryptosporidium was evaluated at six geographically diverse laboratories. The overall sensitivity and specificity of the test was compared to microscopy on a single specimen. Performance relative to patients' clinical status has not been established. The overall sensitivity and specificity for Giardia and Cryptosporidium is listed below.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the Xpect™ Giardia/Cryptosporidium was evaluated at six geographically diverse laboratories. The overall sensitivity and specificity of the test was compared to microscopy on a single specimen. Performance relative to patients' clinical status has not been established. The overall sensitivity and specificity for Giardia and Cryptosporidium is listed below.
Giardia:
Sensitivity: 95.8% (92/96); 95% CI = 89.8-98.4%
Specificity: 98.5% (474/481); 95% CI = 97.0-99.3%
Cryptosporidium:
Sensitivity: 96.4% (108/112); 95% CI = 91.2-98.6%
Specificity: 98.5% (458/465); 95% CI = 96.9-99.3%
Percent Agreement: Xpect™ & Predicate Device vs. Microscopy:
Giardia:
XpectTM Agreement 95.2% (139/146)
Predicate Agreement 93.8% (137/146)
Cryptosporidium:
XpectTM Agreement 95.2% (139/146)
Predicate Agreement 84.9% (124/146)
Cross-reactivity: No cross-reactivity was observed using samples containing the following organisms: Ascaris lumbricoides, Blastocystis hominis, Campylobacter coli, Campylobacter jejuni, Candida albicans, Chilomastix mesnili, Cyclospora cayetanensis, Dientamoeba fragilis, Endolimax nana, Entamoeba coli, Entamoeba hartmanni, Entamoeba histolytica, Enterobius vermicularis, Escherichia coli, hookworm, Hymenolepis nana, Iodamoeba bütschlii, Isospora sp., Microsporidia, Rotavirus, Salmonella choleraesuis subsp. choleraesuis serotype Typhimurium, Shigella dysenteriae, Shigella flexneri, Shigella sonnei, Strongyloides stercoralis, Taenia sp., and Trichura. There was no crossreactivity of Giardia lamblia in the Cryptosporidium test area or of Cryptosporidium parvum in the Giardia test area. Cross-reactivity to Astrovirus and Caliciviruses has not been established.
Interfering Substances: Testing indicated that none of these substances interfered with the expected result except for Imodium® A-D. Imodium® A-D at 20% (v/v) in stool interfered with the detection of low levels of Cryptosporidium antigen.
Reproducibility: Reproducibility testing was conducted at seven sites, including one in-house site, on three separate days with ten blinded samples of varying activity. 100% of the 630 samples tested for Giardia and 630 samples tested for Cryptosporidium produced the expected result.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Giardia:
Sensitivity: 95.8% (92/96); 95% CI = 89.8-98.4%
Specificity: 98.5% (474/481); 95% CI = 97.0-99.3%
Cryptosporidium:
Sensitivity: 96.4% (108/112); 95% CI = 91.2-98.6%
Specificity: 98.5% (458/465); 95% CI = 96.9-99.3%
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.
(k)983399
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
Remel Inc. Lenexa, KS 66215
510(k) Notification Xpect™ Giardia/Cryptosporidium Lateral Flow Assay
NOV 1 0 2003
510(k) Summary
The 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Submitter's Identification:
Submitter's Name and Address:
Remel Inc. 12076 Santa Fe Drive Lenexa, KS 66215 (913) 895-4185
Richard L. Tyson, Ph.D. Contact: 1) Director Product Development and Support Ramsey Operations (763) 712-2347 rtyson@remel.com
-
- Earleen C. Parks Regulatory Affairs Manager Lenexa, KS (913) 895-4185 eparks@remel.com
Date Summary Prepared: November 6, 2003
Device Trade Name:
Xpect™ Giardia/Cryptosporidium Lateral Flow Assay
Predicate Device:
Becton Dickinson ColorPAC™ Giardia/Cryptosporidium Rapid Assay, (k)983399.
Classification Name:
Entamoeba histolytica serological reagents. Cryptosporidium SPP 866.3220 Code: MHJ Giardia SPP 866.3220 Code: MHI
Intended Use:
REMEL's Xpect™ Giardia/Cryptosporidium kit is an in vitro qualitative immunoassay for the detection of Giardia and Cryptosporidium antigens in preserved and unpreserved fecal specimens. This test is intended as an aid in the laboratory diagnosis of suspected Giardia and Cryptosporidium infections.
Page 1 of 5 Section 4
1
Device Description:
The Xpect™ Giardia/Cryptosporidium Lateral Flow Assay is a chromatographic immunoassay that detects the presence of Giardia and Cryptosporidium antigens. The test utilizes sample wicking to capture Giardia and Cryptosporidium antigens on discrete test lines containing antigen-specific antibodies for each organism. A specimen is added to a dilution tube containing a buffered solution. A conjugate containing colored micro-particles linked to monoclonal antibodies specific for Giardia and Cryptosporidium is added. The mixture is dispensed into the sample well of the device and wicks across a membrane containing capture antibody stripes. The Giardia/Cryptosporidium immune complexes if present react with anti-Giardia antibody and/or anti-Cryptosporidium antibody at the test line. Conjugates not bound at the test lines are later captured at the control line containing anti-mouse antibody. A blue line will appear at the Giardia test position if Giardia antigen is present and a pink line will appear at the Cryptosporidium test position if Cryptosporidium antigen is present. A line in the Control position indicates that the test is working properly.
Comparison with Predicate Device:
The following information supports the Statement of Equivalence between the Becton Dickinson ColorPAC™ Giardia/Cryptosporidium Rapid Assay and the Xpect™ Giardia/Cryptosporidium Lateral Flow Assay. The differences in technology do not raise additional concerns regarding safety and effectiveness. Safety and effectiveness are demonstrated to be substantially equivalent.
| Product
Feature | Becton Dickinson ColorPAC™
Giardia/Cryptosporidium Rapid Assay | Xpect™ Giardia/Cryptosporidium Lateral
Flow Assay |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Intended
Use | Detection of Giardia and Cryptosporidium
antigens in aqueous extracts of fecal
specimens | Detection of Giardia and Cryptosporidium
specific antigens in fecal specimens |
| Technology | Qualitative immunochromatographic assay | Qualitative immunochromatographic assay |
| Capture
Antibodies
or
Molecules:
Device | Mouse anti-Cryptosporidium, goat anti-
mouse IgG, Avidin derivative | Rabbit anti-Giardia, rabbit anti-
Cryptosporidium, goat anti-mouse IgG |
| Antibodies:
Conjugate | Rabbit anti-Giardia, monoclonal anti-Giardia
and Cryptosporidium | Monoclonal anti-Giardia and
Cryptosporidium |
| Material:
Membrane | Nitrocellulose | Mylar-backed nitrocellulose |
| Material:
Conjugate | Colloidal dye labeled monoclonal antibodies
to Giardia and Cryptosporidium | Anti-Giardia, anti-mouse, and anti-
Cryptosporidium colored polystyrene
particles diluted in buffer |
| Specimen
Type | Human stool preserved in 10% formalin,
SAF, MIF or Cary Blair | Human stool preserved in 10% formalin,
SAF or Cary Blair |
| Sample
volume | 50μl | 100μl |
2
Specimen Stability:
- . Fresh, untreated stool specimens should be stored at 2-8°C and tested within 48 hours of collection. If fresh specimens cannot be tested within 48 hours. they should be frozen at -20°C or below in a non-defrosting freezer and tested within 2 months of collection. Avoid multiple freeze-thaw cycles.
- Stool specimens treated with 10% formalin or SAF fixatives may be ● refrigerated at 2-8°C or stored at room temperature (20-25°C) and should be tested within 2 months of collection.
- Stool specimens collected in modified Cary Blair Transport Medium with indicator (or equivalent) should be refrigerated and tested within 1 week of collection or frozen (as above) and tested within 2 months of collection. Avoid multiple freeze-thaw cycles.
- . Stool specimens that have been concentrated or treated with PVA fixatives are not suitable for use with this test.
Sensitivity and Specificity Compared to Microscopy:
The performance of the Xpect™ Giardia/Cryptosporidium was evaluated at six geographically diverse laboratories. The overall sensitivity and specificity of the test was compared to microscopy on a single specimen. Performance relative to patients' clinical status has not been established. The overall sensitivity and specificity for Giardia and Cryptosporidium is listed below.
| Giardia | Microscopy | ||
|---|---|---|---|
| + | - | ||
| XpectTM | + | 92 | 7 |
| - | 4 | 474 | |
| Total | 96 | 481 |
Sensitivity: 95.8% (92/96); 95% CI = 89.8-98.4% Specificity: 98.5% (474/481); 95% CI = 97.0-99.3%
| Cryptosporidium | Microscopy | ||
|---|---|---|---|
| + | - | ||
| XpectTM | + | 108 | 7 |
| - | 4 | 458 | |
| Total | 112 | 465 |
Sensitivity: 96.4% (108/112); 95% CI = 91.2-98.6% Specificity: 98.5% (458/465); 95% CI = 96.9-99.3%
3
Percent Agreement: Xpect™ & Predicate Device vs. Microscopy:
The Xpect™ Giardia/Cryptosporidium and a commercially available lateral flow test (the "Predicate Device") were compared side-by-side to microscopy. The Percent Agreement of each assay versus microscopy was as follows:
| Microscopy | ||||
|---|---|---|---|---|
| Giardia | + | - | ||
| XpectTM | + | 19 | 5 | |
| - | 2 | 120 | Agreement | |
| 95.2% (139/146) | ||||
| Total | 21 | 125 | ||
| Predicate | + | 19 | 7 | |
| - | 2 | 118 | Agreement | |
| 93.8% (137/146) | ||||
| Total | 21 | 125 |
| Microscopy | ||||
|---|---|---|---|---|
| Cryptosporidium | + | - | ||
| XpectTM | + | 28 | 5 | |
| - | 2 | 111 | Agreement | |
| Total | 30 | 116 | 95.2% (139/146) | |
| Predicate | + | 29 | 21 | |
| - | 1 | 95 | Agreement | |
| Total | 30 | 116 | 84.9% (124/146) |
4
Cross-reactivity:
No cross-reactivity was observed using samples containing the following organisms: Ascaris lumbricoides, Blastocystis hominis, Campylobacter coli, Campylobacter jejuni, Candida albicans, Chilomastix mesnili, Cyclospora cayetanensis, Dientamoeba fragilis, Endolimax nana, Entamoeba coli, Entamoeba hartmanni, Entamoeba histolytica, Enterobius vermicularis, Escherichia coli, hookworm, Hymenolepis nana, Iodamoeba bütschlii, Isospora sp., Microsporidia, Rotavirus, Salmonella choleraesuis subsp. choleraesuis serotype Typhimurium, Shigella dysenteriae, Shigella flexneri, Shigella sonnei, Strongyloides stercoralis, Taenia sp., and Trichura. There was no crossreactivity of Giardia lamblia in the Cryptosporidium test area or of Cryptosporidium parvum in the Giardia test area. Cross-reactivity to Astrovirus and Caliciviruses has not been established.
Interfering Substances:
Prior to testing, positive and negative samples were spiked (20% v/v) with blood, mucin, fecal fat or the following over-the-counter anti-diarrheal products: Pepto-Bismol®, Imodium® A-D, and Kaopectate® (active ingredients: bismuth subsalicylate, loperamide HCl, and attapugite respectively). Testing indicated that none of these substances interfered with the expected result except for Imodium® A-D. Imodium® A-D at 20% (v/v) in stool interfered with the detection of low levels of Cryptosporidium antigen.
Reproducibility:
Reproducibility testing was conducted at seven sites, including one in-house site, on three separate days with ten blinded samples of varying activity. 100% of the 630 samples tested for Giardia and 630 samples tested for Cryptosporidium produced the expected result.
Conclusion:
Overall, the results from the clinical and POL investigation demonstrate that the Xpect™ Giardia/Cryptosporidium Lateral Flow Assay is substantially equivalent to microscopic examination and the Becton Dickinson ColorPAC™ Giardia/Cryptosporidium Rapid Assay when used in accordance with the proposed labeling.
5
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services (CA). The logo consists of a stylized depiction of a bird in flight, composed of three curved lines that suggest feathers or wings. The bird is oriented towards the upper right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (CA)" in a circular arrangement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 0 2003
Remel Inc. c/o Earleen C. Parks Regulatory Affairs Manager 12076 Santa Fe Drive Lenexa, KS 66215
Re: K031834
Trade/Device Name: Xpect™ Giardia/Cryptosporidium Lateral Flow Assay Regulation Number: 21 CFR 866.3220 Regulation Name: Entamoeba Histolytica Serological Reagents Regulatory Class: Class II Product Code: MHI, MHJ Dated: October 1, 2003 Received: October 3, 2003
Dear Ms. Parks:
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. Iisting 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).
6
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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely vours.
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
INDICATIONS FOR USE
510(k) Number (if known):
Xpect™ Giardia/Cryptosporidium Device Name:
Indications For Use: REMEL's Xpect™ Giardia/Cryptosporidium kit is an in vitro qualitative immunoassay for the detection of Giardia and Cryptosporidium antigens in preserved and unpreserved fecal specimens. This test is intended as an aid in the laboratory diagnosis of suspected Giardia and Cryptosporidium infections.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence Of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | ✓ |
|---|---|
| ------------------------------------------ | --------------------------------------------------------- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
| Division Sign-Off | |
|---|---|
| Say | |
| 4/10/03 |
Office of In Vitro Diagnostic Device
Evaluation and Safety
| 510(k) | K031834 |
|---|---|
| -------- | --------- |