GIARDIA/CRYPTOSPORIDIUM CHEK

K051929 · Techlab, Inc. · MHJ · Nov 17, 2005 · Microbiology

Device Facts

• Record ID: K051929
• Device Name: GIARDIA/CRYPTOSPORIDIUM CHEK
• Applicant: Techlab, Inc.
• Product Code: MHJ · Microbiology
• Decision Date: Nov 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3220
• Device Class: Class 2

Indications for Use

The GIARDIA/CRYPTOSPORIDIUM CHEK™ test is an enzyme immunoassay for the qualitative detection of Giardia cyst and Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Giardia and/or Cryptosporidium gastrointestinal infections.

Device Story

GIARDIA/CRYPTOSPORIDIUM CHEK™ is an enzyme immunoassay (ELISA) for qualitative detection of Giardia cyst and Cryptosporidium oocyst antigens in human fecal specimens. Device utilizes microassay plates coated with monoclonal antibodies and a conjugate containing polyclonal antibodies. Process: diluted fecal specimen added to well; immobilized antibodies bind target antigens; conjugate binds antigen-antibody complex; unbound material washed away; substrate added to produce colorimetric signal indicating presence of antigens. Used in clinical laboratory settings by trained personnel. Output is visual or spectrophotometric color change, aiding clinicians in diagnosing gastrointestinal parasitic infections. Benefits include rapid, sensitive detection of pathogens in symptomatic patients.

Clinical Evidence

Clinical evaluation compared subject device to a commercially available ELISA (n=590) and IFA-confirmed microscopy (n=217). Results vs. ELISA: 98.6% positive agreement, 98.7% negative agreement, 98.6% overall agreement. Results vs. microscopy: 97.6% sensitivity, 100% specificity, 98.6% correlation. Reproducibility testing across three sites showed 100% correlation. Analytical sensitivity established at 375 Giardia cysts/mL and 6250 Cryptosporidium oocysts/mL. No cross-reactivity observed with 30+ intestinal pathogens or common bacterial/viral strains.

Technological Characteristics

ELISA-based immunoassay. Uses monoclonal antibodies (immobilized on microassay plate) and polyclonal antibodies (conjugate) for antigen detection. Form factor: microplate assay. Energy source: none (manual/instrument-read colorimetric). Connectivity: standalone. Sterilization: not applicable (in vitro diagnostic kit).

Indications for Use

Indicated for patients with diarrhea suspected of having Giardia and/or Cryptosporidium gastrointestinal 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

• ProSpecT® Giardia/Cryptosporidium Microplate Assay (K955157)
• Merifluor™ Cryptosporidium / Giardia Kit (K912408)

Submission Summary (Full Text)

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#### 7. 510(k) SUMMARY

# NOV 1 7 2005

| Contact Information | David M. Lyerly<br>Vice-President, Research & Development<br>TECHLAB®, Inc.<br>2001 Kraft Drive<br>Corporate Research Center<br>Blacksburg, VA 24060-6364<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail] | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Date Prepared | July 12, 2005 | |
| Product and Trade Name | GIARDIA/CRYPTOSPORIDIUM CHEKTM | |
| Classification | Giardia spp.<br>21 CFR 866.3220 | Product Code: MHI |
| | Cryptosporidium spp.<br>21 CFR 866.3220 | Product Code: MHJ |
| Predicate Devices | ProSpecT® Giardia/Cryptosporidium Microplate Assay<br>Remel (Lenexa, KS - formerly Alexon Biomedical, Inc.)<br>K955157<br><br>MerifluorTM Cryptosporidium / Giardia Kit<br>Meridian Diagnostics (Cincinnati, Ohio) | |

## Intended Use

The GIARDIA/CRYPTOSPORIDIUM CHEK™ test is an enzyme immunoassay for the qualitative detection of Giardia cyst and Cryptosporidium oocyst antigen in buman fer al specimens. It is indicated for use as an aid in the diagnosis of patients with diaman tour .
Clearly and and and Giardia and/or Cryptosporidium gastrointestinal infections.

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### Device Description

The GIARDIA/CRYPTOSPORIDIUM CHEK™ test uses monoclonal and polyclonal antibodies to cell-surface antigens of Giardia and an oocyst antigen of Cryptosporidium. The Microassay Plate in the kit contains immobilized monoclonal antibodies against the antigens and the Conjugate consists of polyclonal antibodies against the antigens. In the assay, an aliquot of a diluted fecal specimen is transferred to a microassay well. The immobilized monoclonal antibodies bind the Giardia and Cryptosporidium antigens if the antigens are present. Upon addition, Conjugate then binds to the antigen/antibody complex. Any unbound materials are removed during the washing steps. Following the addition of substrate, a color is detected due to the enzyme-antibody-antigen complexes that formed in the presence of Giardia or Cryptosporidium antigens and Conjugate.

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| Kit Name | 510(k)<br>Numbers | Intended Use | Format | Materials | Target<br>Population |
|-----------------------------------------------------------|---------------------------|----------------------------------------------------------------------------------------------|----------------------------------|-------------------------------------------------------------------------|------------------------------------------------------------------------------|
| GIARDIA/<br>CRYPTOSPORIDIUM<br>CHEKTM | Subject to<br>this 510(k) | Detection of<br>Giardia cyst and<br>Cryptosporidium<br>oocyst antigen in<br>fecal specimens | ELISA | Highly specific<br>antibodies against<br>Giardia and<br>Cryptosporidium | Persons suspected<br>of having Giardia<br>OT<br>Cryptosporidium<br>infection |
| Microscopy | N/A | Direct detection of<br>Giardia cysts and<br>Cryptosporidium<br>oocysts in fecal<br>specimens | Microscopy | Various Stains | Persons suspected<br>of having Giardia<br>or<br>Cryptosporidium<br>infection |
| ProSpecT® Giardia/<br>Cryptosporidium<br>Microplate Assay | K955157 | Detection of<br>Giardia cyst and<br>Cryptosporidium<br>oocyst antigen in<br>fecal specimens | ELISA | Highly specific<br>antibodies against<br>Giardia and<br>Cryptosporidium | Persons suspected<br>of having Giardia<br>or<br>Cryptosporidium<br>infection |
| Merifluor™<br>Cryptosporidium/<br>Giardia Kit | K912408 | Direct detection of<br>Giardia cysts and<br>Cryptosporidium<br>oocysts in fecal<br>specimens | DFA -<br>Immuno-<br>fluorescence | Highly specific<br>antibodies against<br>Giardia and<br>Cryptosporidium | Persons suspected<br>of having Giardia<br>Or<br>Cryptosporidium<br>infection |

# 7.1 Comparative Information of Equivalent Devices

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#### 7.2 Summary of Performance Data

#### Summary of Clinical Evaluations 7.2.1

Tables 1 and 2 display the comparison of the GIARDIA/CRYPTOSPORIDIUM CHEK™ test to a commercially available ELISA and to microscopy. Results are compiled from the three clinical study sites and include all samples used in the clinical evaluation of the test.

Table 1 displays the comparison of the GIARDIA/CRYPTOSPORIDIUM CHEK™ test to a commercially available ELISA and to microscopy from all three test sites. The results show that, compared to a commercially available ELISA, the GIARDIA/CRYPTOSPORIDIUM CHEK™ test exhibited 98.6% agreement for positive specimens, 98.7% agreement for negative specimens, and 98.6% agreement overall.

Table 2 displays the comparison of the GIARDIA/CRYPTOSPORIDIUM CHEK™ test to IFA-confirmed microscopy results from Site 1. The results show that, compared to microscopic analysis, the GIARDIA/CRYPTOSPORIDIUM CHEK™ test exhibited 97.6% sensitivity, 100% specificity, and 98.6% correlation.

| TABLE 1: SUMMARY OF ALL STUDIES<br>GIARDIA/CRYPTOSPORIDIUM CHEK™<br>Comparison to a commercially available ELISA<br>(n = 590) | ProSpecT® Giardia/Cryptosporidium<br>Microplate Assay | | | |
|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|----------|----------|-------|
| | | Positive | Negative | Total |
| GIARDIA/CRYPTOSPORIDIUM CHEK™ | Positive | 283 | 4 | 287 |
| TECHLAB®, Inc. | Negative | 4 | 299 | 303 |
| | Total | 287 | 303 | 590 |

| GIARDIA/CRYPTOSPORIDIUM CHEK™<br>vs. ProSpecT® Giardia/Cryptosporidium<br>Microplate Assay | Percent<br>Agreement | 95%<br>Confidence Interval |
|--------------------------------------------------------------------------------------------|----------------------|----------------------------|
| Percent Agreement - Positive Specimens | 98.6% | 96.2% - 99.6% |
| Percent Agreement - Negative Specimens | 98.7% | 96.4% - 99.6% |
| Percent Agreement - Overall | 98.6% | 98.4% - 98.8% |

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| TABLE 2: SUMMARY OF ALL STUDIES<br>GIARDIA/CRYPTOSPORIDIUM CHEK™<br>Comparison to Microscopy | Microscopy | | | |
|----------------------------------------------------------------------------------------------|------------|----------|----------|-------|
| (n = 217) | | Positive | Negative | Total |
| GIARDIA/CRYPTOSPORIDIUM CHEK™ | Positive | 121 | 0 | 121 |
| | Negative | ಗೆ | ਹੈ ਤੇ | 96 |
| | Total | 124 | ਹੈਤੇ | 217 |

| GIARDIA/CRYPTOSPORIDIUM CHEKTM<br>vs. Microscopy | Result | 95%<br>Confidence Interval |
|--------------------------------------------------|--------|----------------------------|
| Sensitivity | 97.6% | 92.6% - 99.4% |
| Specificity | 100% | 95.1% - 100% |
| Predictive Positive Value | 100% | 96.2% - 100% |
| Predictive Negative Value | 96.9% | 90.5% - 99.2% |
| Correlation | 98.6% | 98.2% - 98.9% |

### 7.2.2 Reproducibility

Multi-site proficiency testing was conducted to establish the ability of the GIARDIA/CRYPTOSPORIDIUM CHEK™ test to provide reproducible results in laboratory settings. A fecal panel was assembled and tested at TECHLAB®, Inc. Identical aliquots of the panel were tested at TECHLAB®, Inc. and two independent laboratories using the GIARDIA/CRYPTOSPORIDIUM CHEK™ test. The fecal panel consisted of 24 samples: eight Giardia-positive samples, eight Cryptosporidium-positive samples, and eight samples negative for both parasites. Samples were selected that provided a range of absorbance values over the working range of the GIARDIA/CRYPTOSPORIDIUM CHEK™ test (OD450 reading 0.0 - 4.0), including positive samples close to the positive/negative cut-off absorbance (OD450 0.150). Each sample was tested during three independent trials over a three-day period. Proficiency testing demonstrated 100% correlation for all samples from all three testing sites.

#### 7.2.3 Sensitivity

Sensitivity to each antigen preparation was evaluated in 6 separate trials, using three different lots of the GIARDIA/CRYPTOSPORIDIUM CHEK™ test. The GIARDIA/CRYPTOSPORIDIUM CHEK™ test was consistently positive at 375 Giardia cysts/mL, 0.8 ng recombinant cyst wall protein/mL, and 6250 Cryptosporidium oocysts/mL.

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### 7.2.4 Specificity

### Crossreactivity

An independent diagnostics laboratory evaluated the GIARDIA/CRYPTOSPORIDIUM CHEK™ test using fecal specimens found to be positive for a variety of intestinal pathogens. No cross reactivity was observed with fecal specimens that contained any of the pathogens listed below. The number of specimens tested with each organism is shown in parentheses.

| Ascaris lumbricoides eggs (26) | Entamoeba coli (17) |
|----------------------------------|--------------------------------------|
| Blastocystis hominis (31) | Entamoeba hartmanni (4) |
| Chilomastix mesnili (2) | Enterobius vermicularis eggs (6) |
| Cyclospora cayetanensis (1) | Hymenolepis nana eggs (4) |
| Dientamoeba fragilis (10) | Iodamoeba bütschlii (4) |
| Diphyllobothrium latum eggs (1) | Strongyloides stercoralis larvae (2) |
| Endolimax nana (36) | Taenia spp. eggs (2) |
| Entamoeba histolytica/dispar (9) | Trichuris trichiura eggs (20) |

The GIARDIA/CRYPTOSPORIDIUM CHEK™ test was evaluated for crossreactivity with the bacterial and viral strains listed below. None of the strains were shown to crossreact with the GIARDIA/CRYPTOSPORIDIUM CHEK™ test.

| Escherichia coli | Escherichia coli ETEC (enterotoxic) |
|--------------------------|------------------------------------------|
| Escherichia coli 0157H7 | Escherichia coli EPEC (enteropathogenic) |
| Yersinia enterocolitica | Escherichia coli EIEC (enteroinvasive) |
| Aeromonas hydrophila | Salmonella typhimurium |
| Shigella dysenteriae | Shigella flexneri |
| Salmonella typhimurium | Campylobacter coli |
| Campylobacter fetus | Clostridium difficile |
| Vibrio parahaemolyticus | Staphylococcus aureus (Cowan's) |
| Staphylococcus aureus | Staphylococcus epidermidis |
| Klebsiella pneumoniae | Enterococcus faecalis |
| Clostridium bifermentans | Bacteroides fragilis |
| Bacillus subtilis | Bacillus cereus |
| Adenovirus type 1 | Adenovirus type 2 |
| Adenovirus type 3 | Adenovirus type 5 |
| Adenovirus type 40 | Adenovirus type 41 |
| Human coronavirus | Coxsackievirus B2 |
| Coxsackievirus B3 | Coxsackievirus B4 |
| Coxsackievirus B5 | Echovirus 9 |
| Echovirus 11 | Echovirus 18 |
| Echovirus 22 | Echovirus 33 |
| Enterovirus type 68 | Enterovirus type 69 |
| Enterovirus type 70 | Enterovirus type 71 |

## Interfering Substances

The following substances had no effect on positive or negative test results analyzed at the concentrations indicated: mucin (3.5% w/v), human blood (40% w/v), Imodium® (5% w/v), Kaopectate® (5 mg/mL), Pepto-Bismol® (5% w/v), fecal fat (stearic acid - 40% w/v), Metronidazole (0.25% w/v), Vancomycin (0.25% w/v).

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stylized lines representing its wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 1 7 2005

David M. Lverly, Ph.D. Vice President of Research and Development TECHLAB®, Inc. 2001 Kraft Drive Blacksburg, VA 24060-6358

k051929 Trade/Device Name: GIARDIA/CRYTOSPORIDIUM CHECK™ Regulation Number: 21 CFR 866.3220 Regulation Name: Entamoeba Histolytica Serological Reagents Regulatory Class: Class II Product Code: MHJ Dated: October 20, 2005 Received: October 25, 2005

Dear Dr. Lyerly:

Re:

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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### 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). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sale, a Hom

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

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#### 2. INDICATIONS FOR USE

510(k) Number (if known): K 051929

GIARDIA/CRYPTOSPORIDIUM CHEK™ Device Name:

Indications For Use:

The GIARDIA/CRYPTOSPORIDIUM CHEK™ test is an enzyme immunoassay for the qualitative detection of Giardia cyst and Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Giardia and/or Cryptosporidium gastrointestinal infections.

FOR IN VITRO DIAGNOSTIC USE.

Prescription Use v (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Luddi L. Poole

sion Sign-Off

Page 1 of 1

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K051929

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