(245 days)
Merifluor™ Cryptosporidium / Giardia Kit, GIARDIA II, CRYPTOSPORIDIUM II
Not Found
No
The device description details a rapid membrane immunoassay that relies on antibody-antigen binding and visual interpretation of color lines, with no mention of computational analysis, algorithms, or learning processes.
No.
The device is a diagnostic test used to detect antigens of Giardia and Cryptosporidium to aid in the diagnosis of infection, not to treat it.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use... to aid in the diagnosis of Giardia and/or Cryptosporidium gastrointestinal infection."
No
The device description clearly outlines a physical immunoassay test kit with components like a test device, reaction window, immobilized antibodies, conjugate, diluent, wash buffer, and substrate. This is a hardware-based diagnostic test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection and differentiation of Giardia cyst antigen and Cryptosporidium oocyst antigen in a single test device" and is "intended for use with human fecal specimens from patients with gastrointestinal symptoms to aid in the diagnosis of Giardia and/or Cryptosporidium gastrointestinal infection." This clearly describes a test performed in vitro (outside the body) on a human specimen to provide information for diagnosis.
- Device Description: The description details a laboratory test using antibodies and enzymatic reactions to detect specific antigens in a sample. This is characteristic of an in vitro diagnostic test.
- Anatomical Site: The test uses "human fecal specimens," which are biological samples taken from the human body for analysis.
- Performance Studies: The document describes clinical performance studies comparing the device to other diagnostic methods (Microscopy and ELISAs) using human specimens, which is a standard requirement for demonstrating the performance of an IVD.
- Predicate Devices: The mention of predicate devices (Merifluor™ Cryptosporidium / Giardia Kit; GIARDIA II; CRYPTOSPORIDIUM II) further confirms that this device is being compared to other legally marketed IVDs.
All these elements align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the simultaneous qualitative detection and differentiation of Giardia cyst antigen and Cryptosporidium oocyst antigen in a single test device. It is intended for use with human fecal specimens from patients with gastrointestinal symptoms to aid in the diagnosis of Giardia and/or Cryptosporidium gastrointestinal infection. The test results should be considered in conjunction with the patient history.
Product codes (comma separated list FDA assigned to the subject device)
MHJ, MHJ, MHI
Device Description
The GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test is a rapid membrane immunoassay for the simultaneous detection of Giardia cyst antigen and Cryptosporidium occyst antigen in a single test device. It is performed with a 25 to 30-minute total incubation time. The GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test uses monoclonal and polyclonal antibodies to cell-surface antigens of the device contains a Reaction Window with three vertical lines of immobilized antibodies. The Giardia test line ("Giar") contains mouse monoclonal antibodies against Giardia. The Crypto test line ("Cryp") contains mouse monoclonal antibodies against Cryptosporidium. The control line ("C") is a dotted line that contains anti-horseradish peroxidase (HRP) antibodies. The Conjugate consists of polyclonal antibodies coupled to horseradish peroxidase. To perform the test, the sample is added to a tube containing a mixture of Diluent and Conjugate. The diluted sample-conjugate mixture is added to the Sample Well and the device is allowed to incubate at room temperature for 15 minutes. During the incubation, cyst antigens in the sample bind the antibody-peroxidase conjuqates. The antigen-antibody-conjugate complexes migrate through a filter pad to a membrane where they are captured by the immobilized Giardia and/or Cryptosporidium-specific antibodies in the test lines. The Reaction Window is subsequently washed with Wash Buffer, followed by the addition of Substrate. After a 10 minute incubation period, the reaction is examined visually for the appearance of a vertical blue line on either side of the Reaction Window. A blue line indicates a positive "control" reaction, indicated by a vertical dotted blue line under the "C" portion of the Reaction Window. confirms that the test is working properly and the results are valid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human fecal specimens
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)
Clinical Performance:
The performance of the GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test was evaluated at 3 geographically diverse sites.
At Site #1 and Site #3, the performance was compared to Microscopy (IFA) and included 220 fresh, 140 frozen, 216 preserved-formalin, and 215 preserved-SAF specimens.
At Site #1 and #2, the performance was compared to two commercially available ELISAs (predicate devices for Giardia and Cryptosporidium) and included 349 fresh, 322 frozen, 36 preserved-formalin, and 142 preserved-SAF specimens.
Analytical Sensitivity:
The analytical sensitivity was determined by spiking purified Giardia cysts or Cryptosporidium oocysts quantified by immunofluorescent antibody microscopy (IFA) into negative human fecal specimens.
The limit-of-detection (LOD) for the assay was determined to be 6000 cysts/mL of feces for Giardia (equivalent to 133 cysts detected per test) and 6000 oocysts/mL feces for Cryptosporidium (equivalent to 133 oocysts detected per test).
Cross-Reactivity:
The test was evaluated for cross-reactivity with various bacterial and viral strains. None of the listed strains (e.g., Aeromonas hydrophila, Enterococcus faecalis, Escherichia coli, Salmonella typhimurium, Staphylococcus aureus, Human Adenovirus, Coxsackievirus, Echovirus, Human Enterovirus) showed cross-reactivity.
No cross-reactivity was observed with other parasites in fecal specimens documented to be positive by microscopy (e.g., Ascaris lumbricoides eggs, Blastocystis hominis, Chilomastix mesnili, Cyclospora cayetanensis, Dientamoeba fragilis, Diphyllobothrium latum eggs, Endolimax nana, Entamoeba coli, Entamoeba hartmanni, Entamoeba histolytica/E. dispar, Hookworm eggs, Iodamoeba butschlii, Trichuris trichiura eggs).
Interfering Substances:
Common interfering substances (Hog gastric mucin, Human blood, Barium sulfate, Kaopectate®, Pepto-Bismol®, Steric/Palmitic Acid, Metronidazole, Vancomycin) had no effect on positive or negative test results at indicated concentrations.
Reproducibility:
22 pre-characterized fecal specimens (6 Giardia-positive, 6 Cryptosporidium-positive, 4 Giardia/Cryptosporidium-positive, 6 negative) were tested at 3 sites, twice a day over 5 days by multiple technicians using 2 different kit lots. The results showed 100% correlation with in-house results and consistency among sites.
Precision - Intra-assay:
6 positive fecal specimens (2 Giardia, 2 Cryptosporidium, 2 both) and 6 negative fecal specimens were assayed on 5 cassettes. All positives remained positive and all negatives remained negative.
Precision - Inter-assay:
16 positive fecal specimens (6 Giardia, 6 Cryptosporidium, 4 both) and 6 negative fecal specimens were assayed twice a day over a four-day period. All positives remained positive and all negatives remained negative.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
For Giardia spp. (compared to Microscopy - IFA):
Sensitivity: 98.9% (95% Confidence Limits: 95.7 - 99.8%)
Specificity: 100% (95% Confidence Limits: 99.2 - 100%)
Correlation: 99.7% (95% Confidence Limits: 99.7 - 99.7%)
For Cryptosporidium spp. (compared to Microscopy - IFA):
Sensitivity: 100% (95% Confidence Limits: 96.7 – 100%)
Specificity: 99.8% (95% Confidence Limits: 99.0 – 100%)
Correlation: 99.9% (95% Confidence Limits: 100 – 100%)
For Giardia Line (compared to Commercial ELISA for Giardia Detection):
Percent Positive Agreement: 99.1% (95% Confidence Limits: 96.3 - 99.8%)
Percent Negative Agreement: 99.7% (95% Confidence Limits: 98.7 - 99.9%)
Overall Percent Agreement: 99.5% (95% Confidence Limits: 99.5 - 99.5%)
For Cryptosporidium Line (compared to Commercial ELISA for Cryptosporidium Detection):
Percent Positive Agreement: 99.2% (95% Confidence Limits: 95.2 - 100%)
Percent Negative Agreement: 99.6% (95% Confidence Limits: 98.7 - 99.9%)
Overall Percent Agreement: 99.5% (95% Confidence Limits: 99.5 - 99.5%)
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.
Merifluor™ Cryptosporidium / Giardia Kit, GIARDIA II, CRYPTOSPORIDIUM II
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
510(k) SUMMARY
| Contact Information | Donna T. Link
Director QA, RA and Compliance
TECHLAB®, Inc.
2001 Kraft Drive
Corporate Research Center
Blacksburg, VA 24060
Phone: 540-953-1664
FAX: 540-953-1665
Email: dlink@techlab.com |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | 09 August 2011 |
| Product and Trade Name | GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ |
| Classification | 21 CFR 866.3220 |
Predicate Devices
- Merifluor™ Cryptosporidium / Giardia Kit .
- GIARDIA II .
- . CRYPTOSPORIDIUM II
Intended Use
The GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the simultaneous qualitative detection and differentiation of Giardia cyst antiqen and Cryptosporidium oocyst antigen in a single test device. It is intended for use with human fecal specimens from patients with gastrointestinal symptoms to aid in the diagnosis of Giardia and/or Cryptosporidium gastrointestinal infection. The test results should be considered in conjunction with the patient history.
Device Description
The GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test is a rapid membrane immunoassay for the simultaneous detection of Giardia cyst antigen and Cryptosporidium occyst antigen in a single test device. It is performed with a 25 to 30-minute total incubation time. The GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test uses monoclonal and polyclonal antibodies to cell-surface antigens of the device contains a Reaction Window with three vertical lines of immobilized antibodies. The Giardia test line ("Giar") contains mouse monoclonal antibodies against Giardia. The Crypto test line ("Cryp") contains mouse monoclonal antibodies against Cryptosporidium. The control line ("C") is a dotted line that contains anti-horseradish peroxidase (HRP) antibodies. The Conjugate consists of polyclonal antibodies coupled to horseradish peroxidase. To perform the test, the sample is added to a tube containing a mixture of Diluent and Conjugate. The diluted sample-conjugate mixture is added to the Sample Well and the device is allowed to incubate at room temperature for 15 minutes. During the incubation, cyst antigens in the sample bind the antibody-peroxidase conjuqates. The antigen-antibody-conjugate complexes migrate through a filter pad to a membrane where they are captured by the immobilized Giardia and/or Cryptosporidium-specific antibodies in the test lines. The Reaction Window is subsequently washed with Wash Buffer, followed by the addition of Substrate. After a 10 minute incubation period, the reaction is examined visually for the appearance of a vertical blue line on either side of the Reaction Window. A blue line indicates a positive "control" reaction, indicated by a vertical dotted blue line under the "C" portion of the Reaction Window. confirms that the test is working properly and the results are valid.
Comparative Information of Equivalent Devices
1
| Kit Name | 510(k)
Numbers | Intended Use | Format | Materials | Target
Population |
|-----------------------------------------------|-------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Microscopy | N/A | Direct detection
of Giardia cysts
and
Cryptosporidium
oocysts in fecal
specimens | Microscopy | Various Stains | Persons
suspected of
having Giardia or
Cryptosporidium
infection |
| Merifluor™
Cryptosporidium/
Giardia Kit | K912408 | Direct detection
of Giardia cysts
and
Cryptosporidium
oocysts in fecal
specimens | Microscopy
with Direct
Fluorescent
Antibody –
Immuno-
fluorescence
(IFA) | Highly specific
antibodies
against Giardia
and
Cryptosporidium | Persons
suspected of
having Giardia or
Cryptosporidium
infection |
| GIARDIA II | K033274 | Detection of
Giardia cyst
antigen in fecal
specimens | ELISA | Highly specific
antibodies
against Giardia | Persons
suspected of
having Giardia
infection |
| CRYPTOSPORIDIUM II | K052932 | Detection of
Cryptosporidium
oocyst antigen in
fecal specimens | ELISA | Highly specific
antibodies
against
Cryptosporidium | Persons
suspected of
having
Cryptosporidium
infection |
Summary of Performance Data Clinical Performance
The performance of the GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test was evaluated at 3 geographically diverse sites. At Site #1 and Site #3 the performance of the GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test was compared to Microscopy (IFA) and included 220 fresh, 140 frozen, 216 preserved-formalin, and 215 preserved-SAF. At Site #1 and #2 the performance of the GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test was compared to two commercially available ELISAs (predicate devices for Giardia and Cryptosporidium) and included 349 fresh, 322 frozen, 36 preserved-formalin, and 142 preserved-SAF.
Performance as compared to Microscopy (IFA) - Combined Results for Study Sites #1 and #3:
For Giardia spp.
The following table shows a summary of the clinical performance of the Giardia portion of the GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test. The results show that the GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test exhibited a sensitivity of 98.9%, a specificity of 100%, and an overall correlation of 99.7% with Microscopy - IFA (considered the gold standard).
2
Combined Results - Clinical Performance Comparing the Giardia Line of the GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ Test to Microscopy - IFA
| N = 791 | ||
|---|---|---|
| Microscopy - IFA Giardia positive | Microscopy - IFA Giardia negative | |
| GIARDIA/CRYPTOSPORIDIUM QUIK CHEK TM | ||
| Giardia Line Positive | 181 | 0 |
| GIARDIA/CRYPTOSPORIDIUM QUIK CHEK TM | ||
| Giardia Line Negative | 2 | 608 |
| 95% Confidence Limits | ||
| Sensitivity | 98.9% | 95.7 - 99.8% |
| Specificity | 100% | 99.2 - 100% |
| Correlation | 99.7% | 99.7 - 99.7% |
For Cryptosporidium spp.
The following table shows a summary of the clinical performance of the Cryptosporidium portion of the GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test. The results show that the GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test exhibited a sensitivity of 100%, a spectlicity of 99.8%, and an overall correlation of 99.9% with Microscopy - IFA (considered the gold standard).
Combined Results - Clinical Performance Comparing the Cryptosporidium Line of the GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ Test to Microscopy - IFA
| N = 791 | Microscopy - IFA Crypto. positive | Microscopy - IFA Crypto. negative |
|---|---|---|
| GIARDIA/CRYPTOSPORIDIUM QUIK CHEKTM | ||
| Cryptosporidium Line Positive | 140 | 1 |
| GIARDIA/CRYPTOSPORIDIUM QUIK CHEKTM | ||
| Cryptosporidium Line Negative | 0 | 650 |
| 95% Confidence Limits | ||
| Sensitivity | 100% | 96.7 – 100% |
| Specificity | 99.8% | 99.0 – 100% |
| Correlation | 99.9% | 100 – 100% |
3
Performance as Compared to Two Predicate Devices (commercially available devices for Giardia and Cryptosporidium) - Combined Results for Study Sites #1 and #2:
The combined results of our performance evaluations at Study Site #1 and #2 as compared to two commercially available ELISAs (predicate devices for Giardia and Cryptosporidium) exhibited a 99.1% agreement for Giardia positive specimens, a 99.7% agreement for Giardia negative specimens, with an overall agreement of 99.5%. The test exhibited a 99.2% agreement for Cryptosporidium positive specimens, 99.6% agreement for Cryptosporidium negative specimens, and an overall agreement of 99.5%.
GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test Giardia Line versus the Commercial ELISA for Giardia Detection
| N = 849 | Commercial ELISA -
Giardia positive | Commercial ELISA -
Giardia negative |
|---------------------------------------------------------------|----------------------------------------|----------------------------------------|
| GIARDIA/CRYPTOSPORIDIUM QUIK CHEK TM
Giardia Line Positive | 213 | 2 |
| GIARDIA/CRYPTOSPORIDIUM QUIK CHEK TM
Giardia Line Negative | 2 | 632 |
| 95% Confidence Limits | ||
|---|---|---|
| Percent Positive Agreement | 99.1% | 96.3 - 99.8% |
| Percent Negative Agreement | 99.7% | 98.7 - 99.9% |
| Overall Percent Agreement | 99.5% | 99.5 - 99.5% |
GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test Cryptosporidium Line versus the Commercial ELISA for Cryptosporidium Detection
| N = 849 | Commercial ELISA -
Cryptosporidium positive | Commercial ELISA -
Cryptosporidium negative |
|----------------------------------------------------------------------|------------------------------------------------|------------------------------------------------|
| GIARDIA/CRYPTOSPORIDIUM QUIK CHEK ™
Cryptosporidium Line Positive | 130 | 3 |
| GIARDIA/CRYPTOSPORIDIUM QUIK CHEK ™
Cryptosporidium Line Negative | 1 | 715 |
| 95% Confidence Limits | ||
|---|---|---|
| Percent Positive Agreement | 99.2% | 95.2 - 100% |
| Percent Negative Agreement | 99.6% | 98.7 - 99.9% |
| Overall Percent Agreement | 99.5% | 99.5 - 99.5% |
4
Analytical Sensitivity
The analytical sensitivity of the device was determined by spiking purified Giardia cysts or Cryptosporidium oocysts quantified by immunofluorescent antibody microscopy (IFA) into negative human fecal specimens. The concentration of Giardia cysts and Cryptosporidium occysts in fecal matrix where specimens were positive by the GIARDIA/CRYPTOSPORIDIUM QUIK CHEK test 95% of the time were utilized to describe the assay limitof-detection (LOD). Test results determined the LOD for the assay to be 6000 cysts/mL of feces for Giardia (equivalent to 133 cysts detected per test) and 6000 occysts/mL feces for Cryptosporidium (equivalent to 133 oocysts detected per test). Because the GIARDIA/CRYPTOSPORIDIUM QUIK CHEK test detects soluble antigen in fecal specimens in addition to cysts and occysts, this LOD study represents an estimate of analytical sensitivity based on purified Giardia cysts and Cryptosporidium occysts. Clinical specimens contain varying amounts of free antigen per Giardia cyst or Cryptosporidium oocyst.
Cross-Reactivity
The GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test was evaluated for cross-reactivity with the bacterial and viral strains listed below. None of the strains were shown to cross-react with the GIARDIA/CRYPTOSPORIDIUM QUIK CHEKTM test.
| Aeromonas hydrophila | Clostridium difficile (strain 630) | Salmonella typhimurium |
|---|---|---|
| Bacillus cereus | Enterococcus faecalis | Shigella dysenteriae |
| Bacillus subtilis | Escherichia coli | Shigella flexneri |
| Bacteroides fragilis | Escherichia coli 0157:H7 | Shigella sonnei |
| Campylobacter coli | Escherichia coli ETEC (enterotoxic) | Staphylococcus aureus |
| Campylobacter fetus | Escherichia coli EPEC | Staphylococcus aureus (Cowan's) |
| Campylobacter jejuni | (enteropathogenic) | Staphylococcus epidermidis |
| Candida albicans | Escherichia coli EIEC (enteroinvasive) | Vibrio parahaemolyticus |
| Clostridium bifermentans | Klebsiella pneumoniae | Yersinia enterocolitica |
| Human Adenovirus 1 and 3 | Coxsackievirus B5 | Human paraechovirus 1 (Echovirus |
| Adenovirus, Type 2, 5, 40 and 41 | Human Coronavirus | Enterovirus 68, 69 |
| Human Coxsackievirus B2, B3, | Echovirus 11, 18, 33 | Human Enterovirus 70, 71 |
Human Echovirus 9
n paraechovirus 1 (Echovirus 22) ovirus 68, 69 Human Enterovirus 70, 71 Human rotavirus
Additionally, the GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test was run on fecal specimens documented to be positive for other parasites by microscopy. No cross-reactivity was seen with the following organisms for either the Giardia-portion or the Cryptosporidium-portion of the test. Cross-reactivity to Astrovirus and Caliciviruses has not been established.
Ascaris lumbricoides eggs Blastocystis hominis Chilomastix mesnili Cyclospora cayetanensis
and B4
Dientamoeba fragilis Diphyllobothrium latum eggs Endolimax nana Entamoeba coli
Entamoeba hartmanni Entamoeba histolytica/E. dispar Hookworm egas lodamoeba bütschlii Trichuris trichiura eggs
5
INTERFERING SUBSTANCES (U.S. Formulations)
The following substances had no effect on positive or negative test results analyzed at the concentrations indicated: Hog gastric mucin (3.5% w/v), Human blood (40% v/v), Barium sulfate (5% w/v), Kaopectate® (5% v/v), Pepto-Bismol® (5% v/v), Steric/Palmitic Acid (40% w/v), Metronidazole (0.25% w/v), Vancomycin (0.25% w/v).
REPRODUCIBILITY
A total of 22 fecal specimens were pre-characterized by commercially available predicate devices. The samples included 6 Giardia-positive specimens (3 mid-range positives), 6 Cryptosporidium-positive specimens (3 low positives), and 4 Giardia/Cryptosporidium-positive specimens (2 of which were low Giardia-positives and 2 of which were low Cryptosporidium-positives), and 6 specimens negative for both parasites. All specimens were coded to prevent their identification during testing. Testing was performed at 3 sites. The samples were tested, twice a day over a 5-day period by multiple technicians at each site using 2 different kit lots. A positive and negative control was run with each panel of the masked samples. The results from each laboratory were subsequently submitted to TECHLAB®, Inc. and compared with in-house results. The results were consistent among the different locations, and exhibited a correlation of 100%. The positive specimens consistently tested positive and the negative specimens consistently tested negative at all sites using the GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test.
PRECISION - INTRA-ASSAY
For the determination of intra-assay performance, 6 positive fecal specimens (two positive for Giardia, two positive for Cryptosporidium, two positive for both Giardia and Cryptosporidium) and six negalive fecal specimens were analyzed. Each specimen was assayed on 5 cassettes. All positives remained positive and all negatives remained negative.
PRECISION - INTER-ASSAY
For the determination of inter-assay performance, 16 positive fecal specimens (six positive for Giardia, six positive for Cryptosporidium, and four positive for both Giardia and Cryptosporidium) and six neqative fecal specimens were assayed twice a day over a four-day period using the GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ kit. All positives remained positive and all negatives remained negative.
6
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 emblem featuring a stylized bird-like figure with three curved lines representing its wings or body.
` Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
TechLab, Inc. c/o Ms. Donna T. Link Director, Quality Assurance, Regulatory & Compliance 2001 Kraft Drive Blacksburg, VA 24060-6358
AUG 1 8 2011
Re: K103673
Trade/Device Name: The GIARDIA/CRYTOSPORIDIUM QUIK CHEK™ Regulation Number: 21 CFR§ 866.3220 Regulation Name: Qualitative membrane enzyme immunoassay Regulatory Class: Class II Product Code: MHJ, MHJ, MHI Dated: August 8, 2011 Received: August 8, 2011
Dear Ms. Link:
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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter
7
Page 2 – Donna T. Link
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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Fally acton
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
8
2. INDICATIONS FOR USE
510(k) Number: K103673
Device Name: GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™
Indications For Use:
The GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the simultaneous qualitative detection and differentiation of Giardia cyst antigen and Cryptosporidium oocyst antigen in a single test device. It is intended for use with human fecal specimens from patients with gastrointestinal symptoms to aid in the diagnosis of Giardia and/or Cryptosporidium gastrointestinal infection. The test results should be considered in conjunction with the patient history.
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)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Luddi te. Pode
vision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103673