GIARDIA II

K033274 · Techlab, Inc. · MHI · Nov 4, 2003 · Microbiology

Device Facts

• Record ID: K033274
• Device Name: GIARDIA II
• Applicant: Techlab, Inc.
• Product Code: MHI · Microbiology
• Decision Date: Nov 4, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3220
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The GIARDIA II test is an enzyme immunoassay for the qualitative detection of Giardia lamblia cyst antigen in human fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea to determine the presence of G. lamblia gastrointestinal infection. This test can be used for fecal specimens submitted for routine clinical testing from adults or children. FOR IN VITRO DIAGNOSTIC USE.

Device Story

The TECHLAB GIARDIA 11 is an enzyme-linked immunosorbent assay (ELISA) for the detection of Giardia lamblia in human fecal specimens. The device utilizes a direct format where the detecting antibody is conjugated to horseradish peroxidase (HRP), simplifying the assay by eliminating the need for an anti-rabbit IgG:HRP conjugate. The test uses a one-component substrate containing tetramethyl benzidine and peroxide, and a 0.6 N sulfuric acid stop solution. The device is used in a laboratory setting by trained personnel. The output is a colorimetric signal measured via optical density (OD) at 450 nm or 450/620 nm, which is compared against established thresholds to determine the presence of Giardia antigens. This aids clinicians in the diagnosis of giardiasis.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Enzyme immunoassay (EIA) for qualitative antigen detection. In vitro diagnostic device.

Indications for Use

Indicated for the detection of Giardia lamblia in human fecal specimens.

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.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K 033274 TECHLAB GIARDIA 11

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Reserved Class I device. The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

The changes identified were as follows:

1. A direct format replaced an indirect format making the test simpler to perform. The detecting antibody is directly labeled with horse radish peroxidase thereby eliminating the anti rabbit IgG:HRP conjugate
2. A two component substrate was replaced by a one component substrate. Both contain the same two chemicals namely tetramethyl benzidine and peroxide.
3. Stop solution was weakened from 1M sulfuric acid to 0.6 N (equiv. to 0.3M) sulfuric acid.
4. A sample diluent (buffered protein solution with 0.02% Thimerosal) is included for use.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and performance characteristics which included a comparison of this device test results to the legally marketed predicate device using 110 positive and 93 negative specimens in one study and 88 positive and 40 negative specimens in another study; reproducibility, freeze-thaw and crossreactivity studies.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

Following are the Acceptance Criteria used to determine a successful validation:

Evaluate each test based upon the following specifications and refer to the diagram following.

Giardia Cysts Standard Curve (Plate 1-strips 1 & 2)

Rows A -D: Must be positive, ≥0.150 OD 450 and/or ≥0.090 OD450/620

Rows E - H: May vary between positive and negative

rCWP1 Antigen Standard Curve (Plate 1-strips 3 & 4)

Rows A - D: Must be positive, ≥0.150 OD 450 and/or ≥0.090 OD450/620

Rows E - H: May vary between positive and negative

Positive Control (Plate 1 - strip 5 Plate 2 - strip 5)

Rows A - H: All wells must be positive, ≥1.000 OD 450/620 and OD450

All wells must display a yellow color

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2

Negative Control (Plate 1-strip 6, Plate 2-strip 4)

Rows A - H: All wells must be negative, < 0.150 on OD 450 and/or < 0.090 OD450/620
All wells must be visually clear

Eight Positive Fecals (Plate 2 - strip 1)
All wells must be positive, ≥0.150 OD 450 and/or ≥0.090 OD450/620

Sixteen Negative Fecals (Plate 2- strips 2 & 3)
All wells must be negative, < 0.150 OD 450 and/or < 0.090 OD450/620

Plate 1

| Giardia Cysts/mL | | rCWP1 Antigen ng/mL | | Pos. Ctr. | Neg. Ctr. | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | |
| 150,000 | 150,000 | 25 | 25 | + | - | | | | | | | |
| 15,000 | 15,000 | 12.5 | 12.5 | + | - | | | | | | | |
| 1,500 | 1,500 | 6.25 | 6.25 | + | - | | | | | | | |
| 750 | 750 | 3.13 | 3.13 | + | - | | | | | | | |
| 375 | 375 | 1.56 | 1.56 | + | - | | | | | | | |
| 188 | 188 | 0.78 | 0.78 | + | - | | | | | | | |
| 94 | 94 | 0.39 | 0.39 | + | - | | | | | | | |
| 47 | 47 | 0.2 | 0.2 | + | - | | | | | | | |

Plate 2

| + Fecals formalin | - Fecals formalin | - Fecals unpreserved | Neg. Ctr. | Pos. Ctr. |
| --- | --- | --- | --- | --- |
| 1 | 2 | 3 | 4 | 5 |
| + F | - F | - F | - | + |
| + F | - F | - F | - | + |
| + F | - F | - F | - | + |
| + F | - F | - F | - | + |
| + F | - F | - F | - | + |
| + F | - F | - F | - | + |
| + F | - F | - F | - | + |

c) A declaration of conformity with design controls. The declaration of conformity should include:
i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Statement and the Indications for Use Enclosure.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular

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modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, it is recommended that the device be determined substantially equivalent to the previously cleared device.