GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF

K081064 · Ivd Research, Inc. · MHI · Jan 14, 2009 · Microbiology

Device Facts

• Record ID: K081064
• Device Name: GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF
• Applicant: Ivd Research, Inc.
• Product Code: MHI · Microbiology
• Decision Date: Jan 14, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3220
• Device Class: Class 2

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.

Device Story

Lateral flow immunoassay for detection of Giardia antigens in human fecal specimens. Sample mixed with buffer, dispensed into device sample well, and wicked along nitrocellulose membrane. Membrane contains bound rabbit anti-Giardia and goat-anti-mouse antibodies. Giardia antigen, if present, forms immune complex with gold colloidal-labeled antibodies, producing visible pink-to-purple test line. Control line confirms valid test. Used in clinical laboratories by trained personnel. Provides qualitative visual result to assist clinicians in diagnosing Giardia infections, facilitating timely patient management.

Clinical Evidence

Clinical study compared 210 preserved stool samples against microscopy. Sensitivity: 97.2% (95% CI: 92.2-99.4%); Specificity: 96% (95% CI: 90.2-98.9%). Discrepant analysis using direct immunofluorescence confirmed false positives were actually positive. Analytical sensitivity (LOD) is 20 ng/mL. No cross-reactivity observed with 40+ common enteric pathogens/microorganisms. No interference from blood, mucin, or Imodium.

Technological Characteristics

Qualitative immunochromatographic lateral flow assay. Components: Mylar-backed nitrocellulose membrane, colloidal gold-labeled mouse monoclonal anti-Giardia antibody conjugate, rabbit anti-Giardia capture antibody, goat anti-mouse IgG control line antibody. Form factor: lateral flow test strip in cassette. Standalone device; no energy source required. Manual operation.

Indications for Use

Indicated for the qualitative detection of Giardia antigens in preserved and unpreserved human fecal specimens as an aid in the clinical laboratory diagnosis of suspected Giardia infections. For in vitro diagnostic use.

Regulatory Classification

Identification

Entamoeba histolytica serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Entamoeba histolytica in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Entamoeba histolytica directly from clinical specimens. The identification aids in the diagnosis of amebiasis caused by the microscopic protozoan parasite Entamoeba 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.

Special Controls

*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.

Predicate Devices

• Xpect™ Giardia Lateral Flow Assay (K031942)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
K 081064

B. Purpose for Submission:
To determine substantial equivalence of the device for the detection of Giardia antigens in human fecal specimens.

C. Measurand:
Giardia fecal antigen

D. Type of Test:
Qualitative immunoassay

E. Applicant:
IVD Research Inc.

F. Proprietary and Established Names:
Giardia Fecal Antigen Detection Lateral Flow Kit

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| MHI | Class II | 21 CFR 866.3220 | 83 Microbiology |

H. Intended Use:

1. Intended use:
The Giardia Fecal Antigen Detection Lateral Flow Kit is an in vitro qualitative immunoassay for the detection of Giardia antigens in preserved and unpreserved fecal specimens. This test is indicated as an aid in the clinical laboratory diagnosis of suspected Giardia infections

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2. 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 fecal specimens. This test is indicated as an aid in the clinical laboratory diagnosis of suspected Giardia infections.

For in vitro diagnostic use.

3. Special conditions for use statement:

For prescription use

4. Special instrument requirements:

None

I. Device Description:

The kit contains 20 individually packaged test devices comprised of a nitrocellulose membrane to which rabbit anti-Giardia and goat-anti-mouse antibodies have been bound. The membrane is assembled with a cellulose fiber pad to form the test strip, which is then placed into a plastic housing and sealed. The housing contains a sample window, where the diluted fecal sample is added and a test window where the test result is read. The kit also contains Dilution Buffer A consisting of 6 ml of a buffer and 0.095% sodium azide as a preservative; dilution Buffer B consisting of 6 ml of a buffered 10% formalin solution for diluting fresh or frozen samples; disposable transfer pipets and sample dilution tubes for 20 tests and directions for use. The kit must be stored at 2- 30°C.

J. Substantial Equivalence Information:

The predicate device is Xpect Giardia Lateral Flow Assay (K031942). The new device and predicate are similar in Intended Use, type of technology, use the same Giardia specific monoclonal antibodies and show similar clinical performance. They differ in sample volume and the predicate conjugate has mouse IgG and utilizes a colored polystyrene bead whereas the new device uses a gold colloidal label.

K. Standard/Guidance Document Referenced (if applicable):

N/A

L. Test Principle:

The Giardia Fecal Antigen Detection lateral flow device uses sample wicking to capture Giardia antigen on a discrete test line which contains antibodies specific for

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the Giardia antigen. A fecal specimen is added to a dilution tube and mixed with buffer solution. The mixture is dispensed into the sample well of the device and wicks along the membrane containing capture antibodies bound to the membrane at the test and control lines. The Giardia immune complex, if present, reacts with anti-Giardia 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 will appear in the Test Window – one at the sample line and one at the control line. If no Giardia antigen is present or the level is below the detection limit of the assay, only one pink-to-purple band will appear at the control line. For the test to be valid, there must always be a pink-to-purple line band at the control line.

## M. Performance Characteristics:

### 1. Analytical performance:

a. Reproducibility:

A total of 4 negative, 3 low positive and 3 positive samples, along with positive and negative controls, were run at three separate sites once a day for 3 days. Visual interpretation was similar at all locations and runs. The inter-assay correlation was 100% between the three sites.

b. Linearity/assay reportable range:

N/A

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

N/A

d. Detection limit:

The analytical sensitivity of the device 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 as 20 ng/ml.

e. Analytical specificity:

### Cross-reactivity

No cross-reactions were seen with the following organisms:

Entamoeba hartmanni, Endolimax nana, Entamoeba histolytica/dispar, Entamoeba coli, Blastocystis hominis, Dientamoeba fragilis, Chilomastix

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mesnili, Cyclospora cayetanensis, 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, 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 dysenteria, E. hermannii, Campylobacter jejuni, Salmonella infantis, Yersinia enterocolitica, Enterococcus faecalis and Helicobacter cinaedi. Additionally, six common microorganisms (Campylobacter coli, E. coli, Salmonella enteritidis, Shigella flexneri, Campylobacter jejuni, and Yersinia enterocolitica) spiked into preserved positive and negative fecal specimens did not affect the test result.

## Interfering Substances

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.

f. Assay cut-off:

N/A

2. Comparison studies:

a. Method comparison with predicate device:

One hundred and ten fecal specimens were tested with the Giardia fecal antigen detection lateral flow kit and the predicate device. Results were as follows:

Positive Agreement 98% (48/49)

Negative Agreement 100% (61/61)

b. Matrix comparison:

N/A

3. Clinical studies:

a. Clinical Sensitivity:

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A total of 210 formalin or SAF preserved stools were tested with the Giardia LF test and the results were compared to microscopy. Results were as follows:

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 discrepant samples were re-tested using a direct immunofluorescence assay and shown to be positive.

b. Clinical specificity:

Refer to (a) above

c. Other clinical supportive data (when a. and b. are not applicable):

N/A

4. Clinical cut-off:

N/A

5. Expected values/Reference range:

Normal healthy individuals should be free of Giardia and should test negative. A positive reaction indicates that the patient is shedding detectable amounts of Giardia antigen. Certain populations, such as children in day care settings, have shown higher rates of infection with Giardia than the normal population. Typical prevalence rates for Giardia in developed countries have been reported to be 2-5%.

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:

1. The information submitted in this premarket notification is complete and supports a substantial equivalence decision.