XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020

• K Number: K031942
• Device Name: XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020
• Manufacturer: REMEL INC
• Date Cleared: 2003-11-18 ( 147 days)
• Product Code: MHI
• Regulation Number: 866.3220

Intended 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.

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.

Predicate Devices

(k)983399

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a standard lateral flow immunoassay, which relies on chemical reactions and wicking, not computational algorithms or learning. There is no mention of AI, ML, or image processing.

Therapeutic

No
This device is an in vitro diagnostic immunoassay used for the detection of Giardia antigens, aiding in diagnosis, rather than providing direct therapy or treatment.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that this test is "intended as an aid in the laboratory diagnosis of suspected Giardia infections."

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical, in vitro diagnostic test kit that utilizes a lateral flow assay with physical components (dilution tube, conjugate, membrane, capture antibody stripes, microparticles) to detect antigens. There is no mention of software as the primary or sole component of the device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The "Intended Use / Indications for Use" section explicitly states that the kit is an "in vitro qualitative immunoassay for the detection of Giardia antigens in preserved and unpreserved fecal specimens." The term "in vitro" means "in glass" or "in the lab," indicating that the test is performed outside of the living body.
• Purpose: The test is intended as an "aid in the laboratory diagnosis of suspected Giardia infections." This aligns with the purpose of IVDs, which are used to diagnose diseases or other conditions.
• Specimen Type: The test uses "fecal specimens," which are biological samples taken from the body and analyzed in a laboratory setting.
• Device Description: The description details a laboratory-based assay (chromatographic immunoassay) that detects specific substances (Giardia antigen) in a sample.

All of these points are consistent with the definition and function of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

MHI

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.

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)

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.

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

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 | | | Predicate Device |
---|---|---|---|---
| + | - | |
XpectTM | + | 24 | 7 | Agreement 93.9% (138/147)
| - | 2 | 114 |
| Total | 26 | 121 |

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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Sensitivity: 97.9% (95/97); 95% CI = 92.8-99.4%
Specificity: 97.1% (464/478); 95% CI = 95.1-98.2%
Percent Agreement: 93.9% (138/147)

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.

Becton Dickinson ColorPAC™ Giardia/Cryptosporidium Rapid Assay, (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

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.

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 [phone]

• Richard L. Tyson, Ph.D. Contact: 1) Director Product Development and Support Ramsey Operations [phone] [e-mail]
  • Earleen C. Parks 2) Regulatory Affairs Manager Lenexa, KS [phone] [e-mail]

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:

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.

Page 1 of 4 Section 4

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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.

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.

| Product
Feature | Becton Dickinson ColorPACTM
Giardia/Cryptosporidium Rapid Assay | Xpect™ Giardia Lateral
Flow Assay |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Intended
Use | Detection of Giardia and Cryptosporidium
antigens in aqueous extracts of fecal
specimens | Detection of Giardia 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, goat anti-mouse IgG |
| Antibodies:
Conjugate | Rabbit anti-Giardia, monoclonal anti-Giardia
and Cryptosporidium | Monoclonal anti-Giardia
Normal mouse IgG |
| Material:
Membrane | Nitrocellulose | Mylar-backed nitrocellulose |
| Material:
Conjugate | Colloidal dye labeled monoclonal antibodies
to Giardia and Cryptosporidium | Anti-Giardia and Mouse IgG 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

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 | | | Predicate
Device | |
|----------------|-------|----|---------------------|------------------------------|
| | + | - | | |
| XpectTM | + | 24 | 7 | Agreement
93.9% (138/147) |
| | - | 2 | 114 | |
| | Total | 26 | 121 | |

Page 3 of 4 Section 4

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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.

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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).

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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 [phone]. 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 [phone] or [phone] 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

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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)

OR

Over-The-Counter Use _

Friedrich Jacobi

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K03/942