INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST

K024360 · Alfa Scientific Designs, Inc. · LYR · Jun 10, 2003 · Microbiology

Device Facts

• Record ID: K024360
• Device Name: INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST
• Applicant: Alfa Scientific Designs, Inc.
• Product Code: LYR · Microbiology
• Decision Date: Jun 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3110
• Device Class: Class 1

Indications for Use

The Instant-View® H. Pylori Rapid Test is a rapid lateral flow, qualitative immunoassay. It is intended for use at point of care facilities to detect the presence of IgG antibodies specific to Helicobacter pylori ( H. pylori ) in human blood or serum. It provides an aid in the diagnosis of infection by H. pylori .

Device Story

Lateral flow chromatographic immunoassay; detects IgG antibodies specific to H. pylori in human blood or serum. Device consists of conjugate pad with colloidal gold-coupled H. pylori antigens and nitrocellulose membrane with test line (coated with H. pylori antigens) and control line (coated with goat anti-H. pylori antibodies). Used at point-of-care facilities by healthcare professionals. Sample applied to device; capillary action draws sample across membrane; presence of IgG antibodies results in visible test line. Provides qualitative aid in diagnosis of H. pylori infection. Built-in control line confirms adequate sample volume and proper device function.

Clinical Evidence

Bench testing only. Sensitivity and specificity evaluated using 296 clinically confirmed serum specimens (144 positive, 152 negative). Results: 95% sensitivity (137/144), 93% specificity (141/152), 94% overall accuracy. Reproducibility studies conducted at three physician's office laboratories (POL) using 60 specimens (negative, borderline, positive) in triplicate over three days; intra-assay agreement 99.4-100%, inter-assay agreement 99.8-100%, inter-site agreement 99.9%. No cross-reactivity observed with Campylobacter fetus, C. jejuni, C. coli, or E. coli. No interference from lipids, hemoglobin, bilirubin, or other common serum components.

Technological Characteristics

Lateral flow chromatographic immunoassay. Components: burgundy-colored conjugate pad (colloidal gold-coupled H. pylori antigens), nitrocellulose membrane (test line coated with H. pylori antigens, control line coated with goat anti-H. pylori antibodies). Formats: cassette (dip-strip in plastic housing) or dip-strip. Standalone device; no energy source required. Manual operation.

Indications for Use

Indicated for qualitative detection of IgG antibodies specific to H. pylori in human blood or serum at point-of-care facilities. Evaluated for use with serum specimens of adults, 19 years and older.

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

• SureStep™ H. Pylori Test (K984393, K990892)

Submission Summary (Full Text)

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K024360

## 510(k) Summary Safety and Effectiveness as Required by 21 CFR 807.92

| | Name: | Alfa Scientific Designs, Inc. |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacture and<br>submitter | Address: | 12330 Stowe Drive<br>Poway, CA 92064<br>Telephone: [phone] x 308<br>Fax: [phone] |
| | Contact Person: | Naishu Wang, MD, Ph.D. |
| | E-mail: | [e-mail] |
| | Trade Name: | Instant-View® H. Pylori Rapid Test-Serum (Cassette)<br>Instant-View® H. Pylori Rapid Test-Serum (Dip Strip)<br>Instant-View® H. Pylori Rapid Test-Whole Blood/Serum (Cassette) |
| Device Name | Common Name:<br>Immunoassay, H. Pylori Test<br>Classification:<br>Campylobacter fetus serological reagents<br>(21 CFR § 866.3110) Class I (reserved) | |
| Date of Summary<br>Preparation | June 9, 2003 | |
| Predicate Device | SureStep™ H. Pylori Test, Applied Biotech, Inc.<br>K984393 (Serum and Plasma), K990892 (Whole Blood) | |
| Device Description | A one-step lateral flow chromatographic immunoassay. The test strip<br>in the device consists of 1) a burgundy-colored conjugate pad<br>containing colloidal gold coupled with H. Pylori antigens, and 2)<br>nitrocellulose membrane containing a test line (T line) and a control<br>line (C line). The T line is coated with H. Pylori antigens, and the C<br>line is coated with goat anti-H. Pylori antibodies. | |
| Summary of the<br>Similarity to the<br>Predicate Device | • Both are one-step lateral-flow chromatographic immunoassays.<br>• Both are intended to provide qualitative detection of IgG antibodies<br>specific to H. Pylori.<br>• Both are in vitro diagnostic devices.<br>• Both have a built-in quality control feature, C line, to indicate that<br>an adequate volume of sample is applied and the device performs<br>properly | |

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| Intended Use | The Instant-View® H. Pylori Rapid Test is a rapid lateral flow,<br>qualitative immunoassay. It is intended for use at point of care<br>facilities to detect the presence of IgG antibodies specific to<br>Helicobacter pylori ( <i>H. pylori</i> ) in human blood or serum. It provides<br>an aid in the diagnosis of infection by <i>H. pylori</i> . |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sensitivity and specificity<br>study | The sensitivity and specificity of the device was evaluated with 296<br>clinically confirmed serum specimens, 144 positive and 152 negative.<br>The results demonstrated that the Instant-View® H. Pylori Rapid Test<br>has a sensitivity of 95%( 137/144) and a specificity of 93%( 141/152).<br>The overall accuracy of this device is 94% (278/296). |
| Reproducibility study | Reproducibility studies were performed on 20 negative, 20 borderline<br>positive and 20 positive serum specimens at three physician's office<br>laboratories (POL). Each specimen was run in triplicates for three<br>days at each POL. All the intra-assay agreements were 100% except<br>one, which was 99.4%. The inter-assay agreement was 100% at two<br>POLs and 99.8% at one. The inter-site agreement was 99.9%. |
| Interference and cross-<br>reactivity study | No cross-reaction was observed with the closely related<br>microorganisms, such as <i>Campylobacter fetus, Campylobacter<br/>jejuni, C. coli</i> , or <i>E. coli</i> at a high concentration.<br>No cross-reaction or interference was observed with endogenous<br>substances including common serum components, such as lipids,<br>hemoglobin, bilirubin, and other common biological or chemical<br>analytes at a high concentration evaluated. |
| Formats of the device | The proposed device has two formats: Serum Test and Whole<br>Blood/Serum Test, and the Serum Test has two sub-formats:<br>Cassette and Dip-Strip. A cassette is a device that assembles a dip-<br>strip in a plastic housing. The studies demonstrate all the formats are<br>equivalent. |
| Conclusion | The results of specificity, sensitivity, reproducibility, cross reactivity,<br>and interference studies demonstrate that the Instant-View® H. Pylori<br>Rapid Test is substantially equivalent to the predicate device. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

JUN 1 0 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Naishu Wang, M.D., Ph.D. President Alfa Scientific Designs, Inc. 12330 Stowe Drive Poway, CA 92064

Re: k024360

> Trade/Device Name: Instant-View H. pylori Rapid Test-Serum (Cassette) Instant-View® H. pylori Rapid Test-Serum (Dip Strip) Instant-View® H. pylori Rapid Test-Whole Blood/Serum (Cassette) Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter Fetus Serological Reagents Regulatory Class: Class I Product Code: LYR Dated: May 23, 2003 Received: June 2, 2003

Dear Dr. Wang:

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. Iisting 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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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). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(K) NUMBER (IF KNOWN): k024360

## DEVICE NAME: Instant-View® H. Pylori Rapid Test-Serum (Cassette) Instant-View® H. Pylori Rapid Test-Serum (Dip Strip) Instant-View H. Pylori Rapid Test-Whole Blood/Serum (Cassette)

## INDICATIONS FOR USE:

The Instant-View H. Pylori Rapid Test is a rapid lateral flow, qualitative immunoassay. It is intended for use at point of care facilities to detect the presence of IgG antibodies specific to Helicobacter pylori (H. pylori) in human blood or serum. It provides an aid in the diagnosis of infection by H. pylori. This test has been evaluated for use with serum specimens of adults, 19 years and older.

Blie Munm for Freddie Poole.
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K024360

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)