Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only

K151935 · Alere San Diego, Incorporated · LYR · Aug 12, 2015 · Microbiology

Device Facts

• Record ID: K151935
• Device Name: Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only
• Applicant: Alere San Diego, Incorporated
• Product Code: LYR · Microbiology
• Decision Date: Aug 12, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3110
• Device Class: Class 1

Indications for Use

The Signify® H. pylori cassette is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood, serum or plasma to aid in the diagnosis of H. pylori infection in adults 18 years of age and older. The Signify® H. pylori cassette (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood to aid in the diagnosis of H. pylori infection in adults 18 years of age and older. The Clearview® H. pylori test is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood, serum or plasma to aid in the diagnosis of H. pylori infection in adults 18 years of age and older. The Clearview® H. pylori test is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood to aid in the diagnosis of H. pylori infection in adults 18 years of age and older.

Device Story

Lateral flow immunochromatographic assay; detects IgG antibodies to H. pylori in whole blood, serum, or plasma. Device consists of membrane strip with immobilized anti-human IgG and H. pylori antigen-coated particles in plastic housing. Sample migrates chromatographically; if H. pylori IgG present, colored line appears in test region. Procedural control line confirms proper sample volume and wicking. Used in clinical settings; performed by healthcare professionals. Provides qualitative visual output (colored lines) to aid clinical diagnosis of H. pylori infection.

Clinical Evidence

Bench testing only. Interfering substance study evaluated performance with triglycerides (up to 3454 mg/dL), hemoglobin (up to 1000 mg/dL), bilirubin (up to 1000 mg/dL), and human serum albumin (up to 2000 mg/mL). Hematocrit levels (20% to 67%) also tested. All samples (low positive, high positive, negative) yielded expected results.

Technological Characteristics

Lateral flow immunochromatographic assay. Components: membrane strip with immobilized anti-human IgG, H. pylori antigen-coated particles, plastic housing. Sample volume: ~50 µL. Test time: 10 minutes. Visual endpoint (colored lines).

Indications for Use

Indicated for the qualitative detection of H. pylori antibodies in human whole blood, serum, or plasma specimens.

Regulatory Classification

Identification

Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify Campylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases. Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.

Predicate Devices

• Alere Signify H. pylori - Whole Blood, Serum, Plasma (K024350)
• Alere Signify H. pylori - Whole Blood Only (K024350)
• Alere Clearview H. pylori - Whole Blood, Serum, Plasma (K024350)
• Alere Clearview H. pylori - Whole Blood Only (K024350)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER K151935

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

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.

Trade Names: Alere Signify H. pylori - Whole Blood, Serum, Plasma
Alere Signify H. pylori - Whole Blood Only
Alere Clearview H. pylori - Whole Blood, Serum, Plasma
Alere Clearview H. pylori - Whole Blood Only

510(k) number: K024350

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.

This is a labeling change to remove a limitation for triglycerides as a potentially interfering substance. This labeling change does not affect the intended use or the instructions for use. There were no modifications to the device.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and interfering substances.

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

Based on the risk analysis, analytical validation was conducted to demonstrate that triglyceride levels up to $3454\mathrm{mg/dL}$ do not negatively affect device performance with whole blood, serum, or plasma sample types.

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 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, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.