ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a sequence of handwritten characters. The characters are 'K', 'O', '2', '4', '3', '5', and '0'. The characters are written in black ink on a white background. #### 7. SUMMARY OF 510(k) This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The Assigned 510(k) number is K024350. ## Submitter: ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121 Tel.: 858-535-2030 Fax: 858-535-2038 Establishment Registration Number: 2531491 Owner/Operator Number: 9033096 ## Date: December 27, 2002 ## Contact Person: Edward Tung, Ph.D. ## Product Names: ACON® H. pylori Rapid Test Strip ACON® H. pylori Rapid Test Device #### Common Name: Immunochromatographic test for the qualitative detection of IgG antibodies specific to Helicobacter pylori (H. pylori). {1}------------------------------------------------ ## Classification Information: The ACON® H. pylori Rapid Test Strip and Device are similar to other FDAcleared devices for the qualitative detection of IgG antibodies specific to H. pylori. | Classification: | Class I | |----------------------|------------------------------------------------------------------------------------| | Regulation Number: | 866.3110 | | Product Code: | LYR | | Classification Name: | Campylobacter pylori | | Complexity: | Moderate | | Analyte: | IgG antibodies specific to Helicobacter pylori in human<br>blood, serum or plasma | | Test Category: | Manual procedures with limited steps and limited sample<br>and reagent preparation | ## Intended Use: The ACON® H. pylori Rapid Test Strip and Device are rapid chromatographic immunoassays for the qualitative detection of antibodies to Helicobacter pylori (H. pylori) in whole blood, serum or plasma to aid in the diagnosis of H. pylori infection in adults 18 years of age and older. They are intended for health professionals and professionals at point-of-care sites. ### Description: The ACON® H. pylori rapid Test Strip and ACON® H. pylori rapid Test Device are lateral flow immunochromatographic assays for the qualitative detection of IgG antibodies specific to Helicobacter pylori in whole blood, serum or plasma. They utilize H. pylori antigen coated particles and immobilized anti-human IgG to selectively detect elevated levels of IgG antibodies to H. pylori. These tests can be performed without the use of an instrument. {2}------------------------------------------------ # Comparison to Predicate Devices: A summary of comparison of the features of the ACON® H. pylori Rapid Test Strip, ACON® H. pylori Rapid Test Device, and two predicate devices is shown below: # ACON H. pylori Tests versus Quidel QuickVue One-Step H. pylori gII (K991747) | | ACON® H. pylori Rapid<br>Test Strip | ACON® H. pylori Rapid Test<br>Device | Quidel QuickVue One-<br>Step H. pylori gII | |---------|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | | | | | | Indication<br>for<br>use | A rapid chromatographic<br>immunoassay for the<br>qualitative detection of<br>antibodies to Helicobacter<br>pylori in whole blood to aid in<br>the diagnosis of H. pylori<br>infection. | A rapid chromatographic<br>immunoassay for the qualitative<br>detection of antibodies to<br>Helicobacter pylori in whole blood<br>to aid in the diagnosis of H. pylori<br>infection. | | | Intended Use | Professional | Professional | | | Intended<br>specimen | Whole blood, serum, plasma | Whole blood, serum, plasma | | | Endpoint | Colored Lines | Colored Lines | | | Materials<br>provided | Test strips<br>Disposable sample test tubes<br>Disposable droppers<br>Capillary tube<br>Dispensing bulb<br>Positive control<br>Negative control<br>Buffer<br>Package insert<br>Procedure card | Test devices<br>Disposable droppers<br>Capillary tube<br>Dispensing bulb<br>Positive control<br>Negative control<br>Buffer<br>Package insert<br>Procedure card | | | Methodology | Membrane particle assay | Membrane particle assay | | | Test Time | 10 minutes | 10 minutes | | | Format | Antigen/antibody<br>immunoassay | Antigen/antibody immunoassay | {3}------------------------------------------------ # ACON H. pylori Tests versus Beckman Coulter FlexSure HP (K934863) | | ACON® H. pylori Rapid<br>Test Strip | ACON® H. pylori Rapid Test<br>Device | Beckman Coulter<br>FlexSure HP | |-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | | | | | Indication for use | A rapid chromatographic<br>immunoassay for the<br>qualitative detection of<br>antibodies to Helicobacter<br>pylori in whole blood to aid in<br>the diagnosis of H. pylori<br>infection. | A rapid chromatographic<br>immunoassay for the qualitative<br>detection of antibodies to<br>Helicobacter pylori in whole blood<br>to aid in the diagnosis of H. pylori<br>infection. | A rapid, visually read,<br>qualitative<br>immunochromato-<br>graphic method for the<br>detection of IgG<br>antibodies to H. pylori in<br>serum as an aid in the<br>diagnosis of H. pylori<br>infection in patients with<br>clinical signs and<br>symptoms of<br>gastrointestinal disease is<br>not intended for use with<br>asymptomatic patients. | | Intended Use | Professional | Professional | Professional | | Intended<br>specimen | Whole blood, serum, plasma | Whole blood, serum, plasma | Serum | | Endpoint | Colored Lines | Colored Lines | Colored Lines | | Materials<br>provided | Test strips<br>Disposable sample test tubes<br>Disposable droppers<br>Capillary tube<br>Dispensing bulb<br>Positive control<br>Negative control<br>Buffer<br>Package insert<br>Procedure card | Test devices<br>Disposable droppers<br>Capillary tube<br>Dispensing bulb<br>Positive control<br>Negative control<br>Buffer<br>Package insert<br>Procedure card | Test cards<br>Disposable transfer<br>pipettes<br>Capillary tube<br>Buffer<br>Product Instructions | | Methodology | Membrane particle assay | Membrane particle assay | Membrane particle assay | | Test Time | 10 minutes | 10 minutes | 4 minutes | | Format | Antigen/antibody<br>immunoassay | Antigen/antibody immunoassay | Antigen/antibody<br>immunoassay | # Accuracy A clinical evaluation was conducted using a total of 484 clinical specimens. The detection of H. pylori specific antibodies was done by using the ACON® H. pylori Rapid Test Strip and Test Device, QuickVue One-Step H. pylori gII Test and Beckman FlexSure HP Test. # ACON® H. pylori Rapid Test Strip compared to Quidel QuickVue One-Step H. pylori gII Test Positive Agreement = 92/104 = 88% (81%-94%)* Negative Agreement = 89/96 = 93% (86%-97%) Overall Agreement = 181/200 = 90% (86%-94%) * 95% Confidence Intervals {4}------------------------------------------------ ACON® H. pylori Rapid Test Strip compared to Beckman Coulter FlexSure HP > Positive Agreement = 61/68 = 90% (80%-96%) Negative Agreement = 93/95 = 98% (92%-100%) Overall Agreement = 154/163 = 94% (90%-97%) ACON® H. pylori Rapid Test Strip compared to Culture/Histology: Sensitivity = 120/136 = 88% (82%-93%) Specificity = 164/185 = 89% (83%-93%) Accuracy = 284/321 = 88% (84%-92%) ACON® H. pylori Rapid Test Strip compared to Histology/Rapid Urease Test: > Sensitivity = 50/71 = 70% (58%-81%) Specificity = 79/92 = 86% (77%-92%) Accuracy = 129/163 = 79% (72%-85%) ACON H. pylori Rapid Test Device compared to QuickVue One-Step H. pylori gII Test > Positive Agreement = 92/104 = 88% (81%-94%) Negative Agreement = 89/96 = 93% (86%-97%) Overall Agreement = 181/200 = 90% (86%-94%) ACON H. pylori Rapid Test Device compared to Beckman Coulter FlexSure HP Test > Positive Agreement = 67/68 = 98% (92%-100%) Negative Agreement = 94/95 = 99% (94%-100%) Overall Agreement = 161/163 = 99% (96%-100%) ACON H. pylori Rapid Test Device compared to Culture/ Histology: Sensitivity = 121/136 = 89% (82%-94%) Specificity = 164/185 = 89% (83%-93%) Accuracy = 285/321 = 89% (85%-92%) {5}------------------------------------------------ ACON H. pylori Rapid Test Device compared to Histology/Rapid Urease Test > Sensitivity = 52/71 = 73% (61%-83%) Specificity = 76/92 = 83% (73%-90%) Accuracy = 128/163 = 78% (71%-84%) # Conclusion: Clinical and laboratory studies included in this 510(k) submission demonstrate that the ACON H. pylori Rapid Test Strip and Test Device are substantial equivalent to the QuickVue One-Step H. pylori gII Test and the Beckman Coulter FlexSure HP which are already marketed in the U. S. They further demonstrate that these ACON H. pylori rapid test products are suitable for professional and point-of-care use. {6}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." is arranged in a circular pattern around the bird figure. Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 APR - 2 2003 Edward Tung, Ph.D. Director of Regulatory Affairs ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, CA 92121 Re: k024350 Trade/Device Name: ACON® H. pvlori Rapid Test Strip ACON® H. pylori Rapid Test Device Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter Fetus Serological Reagents Regulatory Class: Class I Product Code: LYR Dated: December 27, 2002 Received: December 30, 2002 Dear Dr. Tung: 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). {7}------------------------------------------------ #### 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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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 {8}------------------------------------------------ #### INDICATIONS FOR USE 9. 510(k) Number: Rose 2009 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - ACON® H. pylori Rapid Test Strip Device Name: ACON® H. pylori Rapid Test Device - The ACON® H. pylori Rapid Test Strip and ACON® H. pylori Rapid Test Indications for Use: Device are rapid chromatographic immunoassays for the qualitative detection of antibodies specific to H. pylori in human whole blood, serum or plasma to aid in the diagnosis of H. pylori infection in adults 18 years of age and older. They are intended for healthcare professionals and professionals at point of care sites only. (Please do not write below this point) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use_ " Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Or (Per 21 CFR 801.109) (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number ***_*** 18