REMEL's Xpect™ Giardia kit is an in vitro qualitative immunoassay for the detection of Giardia antigens in preserved and unpreserved fecal specimens. This test is intended as an aid in the laboratory diagnosis of suspected Giardia infections.

Device Description

The Xpect™ Giardia Lateral Flow Assay is a chromatographic immunoassay that detects the presence of Giardia antigen. The test utilizes sample wicking to capture Giardia antigen on a discrete test line containing antigen-specific antibodies for Giardia. A specimen is added to a dilution tube containing a buffered solution. A conjugate containing colored micro-particles linked to murine monoclonal antibody specific for Giardia is added. The mixture is dispensed into the sample well of the device and wicks along a membrane containing capture antibody stripes. The Giardia immune complex, if present, reacts with anti- Giardia antibody at the test line. Antibody-labeled microparticles not bound at the test line are later captured at the control line containing anti-mouse antibody. A blue line of any intensity (light blue to black) will appear at the Giardia test position if Giardia antigen is present. A complete line at the Control position indicates that the test is working properly.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Xpect™ Giardia Lateral Flow Assay, based on the provided 510(k) notification:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (Xpect™ Giardia)
Preamble device comparison: Not substantially equivalent to the predicate device	Substantially equivalent to the predicate device (Becton Dickinson ColorPAC™ Giardia/Cryptosporidium Rapid Assay)
Sensitivity for Giardia detection:	97.9% (95/97); 95% Confidence Interval (CI) = 92.8-99.4%
Specificity for Giardia detection:	97.1% (464/478); 95% CI = 95.1-98.2%
Percent Agreement with Predicate Device (Positive Agreement):	92.3% (24/26)
Percent Agreement with Predicate Device (Negative Agreement):	94.2% (114/121)
Overall Percent Agreement with Predicate Device:	93.9% (138/147)
Cross-reactivity: No cross-reactivity with specified organisms	No cross-reactivity observed with a list of 24 organisms/pathogens (excluding Astrovirus and Caliciviruses for which it was not established).
Interfering Substances: No interference from specified substances	No interference with expected results from blood, mucin, fecal fat, or common anti-diarrheal products (Pepto-Bismol®, Imodium® A-D, and Kaopectate®).
Reproducibility: Consistent results across sites and days with varying activity.	100% of 630 samples tested produced the expected result across seven sites (including one in-house) on three separate days with ten blinded samples of varying activity.

Study Information

Sample Size Used for the Test Set and Data Provenance:
- Clinical Performance Study (compared to microscopy):
  - Total samples with Giardia present by microscopy: 97
  - Total samples with Giardia absent by microscopy: 478
  - Total samples in this comparison: 575 (97 positive + 478 negative)
  - Data Provenance: The study was evaluated at "six geographically diverse laboratories," indicating a multi-center, likely prospective collection of clinical samples. The country of origin is not explicitly stated but can be inferred to be within the US given the submission to the FDA.
- Comparison to Predicate Device:
  - Total samples: 147 (26 positive by predicate, 121 negative by predicate).
Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- The primary ground truth for the clinical performance study was microscopy. The document does not specify the number of experts (e.g., medical technologists, parasitologists) involved, nor their specific qualifications (e.g., years of experience). It simply states the comparison was "compared to microscopy."
Adjudication Method for the Test Set:
- The document does not explicitly state an adjudication method (like 2+1, 3+1). It implies that the microscopy results served as the definitive ground truth for the comparison.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a rapid diagnostic test (lateral flow immunoassay), not an AI-powered diagnostic imaging or interpretation tool designed to assist human readers.
Standalone (Algorithm Only) Performance:
- Yes, the performance presented in the "Sensitivity/Specificity" table is the standalone performance of the Xpect™ Giardia Lateral Flow Assay, as it directly compares the device's results to the microscopy ground truth. It operates independently of human interpretation beyond reading the positive/negative line.
Type of Ground Truth Used:
- The primary ground truth used for the clinical performance evaluation was microscopy, which involves expert examination of fecal specimens for the presence of Giardia parasites.
Sample Size for the Training Set:
- The document does not specify a separate "training set" or its size. As this is a lateral flow immunoassay, the development process would involve analytical studies and optimization rather than machine learning training on a distinct dataset. The studies described are performance validation studies.
How the Ground Truth for the Training Set Was Established:
- Since a separate training set, in the context of machine learning, is not applicable or described for this device, the method for establishing its ground truth is not provided. The ground truth for the validation test set was established by microscopy.

Summary

{0}------------------------------------------------

K031942

Remel Inc. Lenexa, KS 66215

510(k) Notification Xpect™ Giardia Lateral Flow Assay

NOV 1 8 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 2) Regulatory Affairs Manager Lenexa, KS (913) 895-4185 eparks@remel.com

Date Summary Prepared: November 7, 2003

Device Trade Name:

Xpect™ Giardia Lateral Flow Assay

Predicate Device:

Becton Dickinson ColorPAC™ Giardia/Cryptosporidium Rapid Assay, (k)983399.

Classification Name:

Entamoeba histolytica serological reagents. Giardia SPP 866.3220 Code: MHI

Intended Use:

Page 1 of 4 Section 4

{1}------------------------------------------------

Device Description:

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 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.

ProductFeature	Becton Dickinson ColorPACTMGiardia/Cryptosporidium Rapid Assay	Xpect™ Giardia LateralFlow Assay
IntendedUse	Detection of Giardia and Cryptosporidiumantigens in aqueous extracts of fecalspecimens	Detection of Giardia specific antigens infecal specimens
Technology	Qualitative immunochromatographic assay	Qualitative immunochromatographic assay
CaptureAntibodiesorMolecules:Device	Mouse anti-Cryptosporidium, goat anti-mouse IgG, Avidin derivative	Rabbit anti-Giardia, goat anti-mouse IgG
Antibodies:Conjugate	Rabbit anti-Giardia, monoclonal anti-Giardiaand Cryptosporidium	Monoclonal anti-GiardiaNormal mouse IgG
Material:Membrane	Nitrocellulose	Mylar-backed nitrocellulose
Material:Conjugate	Colloidal dye labeled monoclonal antibodiesto Giardia and Cryptosporidium	Anti-Giardia and Mouse IgG coloredpolystyrene particles diluted in buffer
SpecimenType	Human stool preserved in 10% formalin,SAF, MIF or Cary Blair	Human stool preserved in 10% formalin,SAF or Cary Blair
Samplevolume	50μl	100μl

{2}------------------------------------------------

Remel Inc. Lenexa, KS 66215

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/Specificity:

The performance of the Xpect™ Giardia was evaluated at six geographically diverse laboratories. The overall sensitivity and specificity of the test were compared to microscopy. Performance relative to patients' clinical status has not been established. The overall sensitivity and specificity for Giardia are listed below.

	Microscopy
Giardia		+	-
XpectTM	+	95	14
	-	2	464
	Total	97	478

Sensitivity: 97.9% (95/97); 95% CI = 92.8-99.4% Specificity: 97.1% (464/478); 95% CI = 95.1-98.2% Note : CI = Confidence Interval

Percent Agreement:

The Xpect™ Giardia was compared to a commercially available lateral flow test (the "Predicate Device"). The Percent Agreement of the Xpect™ Giardia assay versus the Predicate Device was as follows:

Giardia			PredicateDevice
	+	-
XpectTM	+	24	7	Agreement93.9% (138/147)
	-	2	114
	Total	26	121

Page 3 of 4 Section 4

{3}------------------------------------------------

Remel Inc. Lenexa, KS 66215

510(k) Notification Xpect™ Giardia Lateral Flow Assay

Cross-reactivity:

No cross-reactivity was observed using samples containing the following organisms: Ascaris lumbricoides, Blastocystis hominis, Campylobacter coli, Campvlobacter iejuni. Candida albicans, Chilomastix mesnili, Cryptosporidium parvum, 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. Strongvloides stercoralis. Taenia sp., and Trichuris trichiura. 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.

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 produced the expected result.

Conclusion:

Overall, the results from the clinical and POL investigation demonstrate that the Xpect™ Giardia 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.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is enclosed within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A."

NOV 1 8 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Richard L. Tyson, Ph.D. Director Product Development and Support Remel Inc. Ramsey Operation 14000 Unity St. NW Ramsey, MN 55303

Re: K031942

Trade/Device Name: Xpect™ Giardia Regulation Number: 21 CFR 866.3220 Regulation Name: Entamoeba Histolytica Serological Reagents Regulatory Class: Class II Product Code: MHI Dated: October 15, 2003 Received: October 17, 2003

Dear Dr. Tyson:

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 vour 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 (OS) regulation (21 CFR Part 820).

{5}------------------------------------------------

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 yours,

Steven Sutman

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

{6}------------------------------------------------

INDICATIONS FOR USE

K031942 510(k) Number (if known):

Xpect™ Giardia Device Name:

Indications For Use: REMEL's Xpect™ Giardia kit is an in vitro qualitative immunoassay for the detection of Giardia antigens in preserved and unpreserved fecal specimens. This test is intended as an aid in the laboratory diagnosis of suspected Giardia 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)

Over-The-Counter Use _

Friedrich Jacobi

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K03/942

Regulation Number and Section

§ 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.