The QuickVue One-Step H. pylori II Test is intended for the rapid, qualitative detection of IgG antibodies specific to Helicobacter pylori in human serum, plasma and whole blood as an aid in the diagnosis of H. pv/ori infection in patients with clinical signs and symptoms of gastrointestinal disease. The test is intended for use bv health care professionals.

Device Description

The QuickVue One-Step H. pylori II Test, a lateral-flow immunoassay using patented technology, employs a monoclonal antibody and purified H. pylori antigen. Shortly after addition of the sample to the Test Cassette, a blue procedural Control Line will appear in the Result Window. If H. pylori-specific lqG is present in the sample, a faint-to-dark red Test Line will also appear in the Result Window. The result is read at 5 minutes. If no blue procedural Control Line develops, the result is considered invalid.

AI/ML Overview

Here is the information about the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the provided text. However, the study aimed to demonstrate "substantial equivalence" to existing methods, and an agreement exceeding 90% was considered acceptable for this purpose.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence	Agreement exceeding 90% in comparison to biopsy and a commercially available EIA

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Over 300 clinical specimens.
Data Provenance: The specimens were obtained from symptomatic and asymptomatic patients undergoing endoscopic examination. The study was a "multi-center field study," implying data from multiple locations, but specific countries are not mentioned. It is a prospective study as it involved collecting clinical specimens and comparing the new device's performance to existing methods.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The text does not specify the number of experts or their qualifications for establishing the ground truth (biopsy and EIA results) for the clinical specimens.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly stated. The comparison was made against "biopsy and to a commercially available EIA," suggesting that the results from these established methods served as the reference without a described adjudication process among multiple reviewers for the ground truth itself.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This device is a rapid, qualitative immunoassay for detecting antibodies, not an AI-powered diagnostic tool requiring human readability or interpretation in the way an MRMC study would typically evaluate. Physician’s Office Laboratory (POL) studies were conducted to show that diverse office personnel could perform the test accurately and reproducibly, but this is different from an MRMC study evaluating human reader performance on diagnostic images with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is an in-vitro diagnostic test kit. The "standalone" performance in this context refers to its intrinsic analytical performance. The study comparing the QuickVue test to biopsy and a commercial EIA constitutes the standalone performance of the device in its intended use, as it directly evaluates the device's accuracy in detecting IgG antibodies. There isn't an "algorithm only without human-in-the-loop" equivalent in this type of diagnostic device.

7. The Type of Ground Truth Used

The ground truth used for the clinical specimen comparison was a combination of:

Biopsy: This refers to the histological examination of tissue samples, which is considered a gold standard for H. pylori detection.
Commercially Available EIA: This is another established serological test method for detecting H. pylori antibodies.

8. The Sample Size for the Training Set

The text does not mention a separate training set or its sample size. This type of device (immunoassay) is typically developed and optimized through laboratory research, and then validated with clinical samples. The "over 300 clinical specimens" are described as being used for the comparative field study, which acts as the validation or test set.

9. How the Ground Truth for the Training Set Was Established

Since a dedicated training set is not explicitly mentioned, the establishment of ground truth for such a set is also not described. The development of the QuickVue One-Step H. pylori II Test would have involved internal validation and optimization against known positive and negative controls in development, but these are not referred to as a "training set" in the context of this regulatory submission.

Summary

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K991747

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION XI.

The following information as presented in the Premarket Notification [510(k)] for the QuickVue One-Step H. pylori II Test constitutes data supporting a substantially equivalent determination.

Product:

QuickVue® One-Step H. pylori II Test

Manufacturer:

QUIDEL Corporation 10165 McKellar Court San Diego, California 92121

Device Classification:

The device, QuickVue One-Step H. pylori II Test, is similar to other FDA-cleared devices used for the qualitative detection of IgG antibodies to Helicobacter pylori directly from clinical specimens. These tests are used to aid in the diagnosis of disease caused by bacteria belonging to the genus Campylobacter and provide epidemiological information on these diseases (21 CFR 866.3110). Helicobacter pylori (formerly Campylobacter pylori) has not yet been classified by the FDA separately from Campylobacter.

The Food and Drug Administration has proposed that serological tests systems for the identification of Helicobacter pylori be classified as Class I.

Intended Use:

Physiologic Basis for the Test:

Helicobacter pylori (formerly Campylobacter pyloridis and Campylobacter pylori) is implicated in the etiology of a variety of gastrointestinal diseases, including non-ulcer dyspepsia, duodenal and gastric ulcer, and active and chronic gastritis, Recent studies also suggest an association of H. pylori infection with stomach cancer; the role of H. pylori and the factors involved in the development of these diseases is still under investigation.

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Symptomatic patients with H. pylori are said to be infected, whereas asymptomatic patients with H. pylori are said to be colonized. Although infections are persistent. several treatment regimens using antibiotics in combination with bismuth compounds have been shown to be effective in treating active H. pvlori infection. Successful eradication of H. pylori is associated with clinical improvement in patients with chronic active gastric ulcer and duodenal ulcer, providing further evidence for a link between H. pylori infection and these diseases.

Principle of the Test:

ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ

人人人: 上一篇:

ﺍﻟﺘﻲ ﻳﺘﻤﺜﻼ

్లో స్టే 发行

Safety and Effectiveness:

Substantial equivalence has been demonstrated between the QuickVue One-Step H. pvlori II Test and biopsy for the detection of H. pylori-specific IqG antibodies. Using over 300 clinical specimens obtained from symptomatic and asymptomatic patients undergoing endoscopic examination, a comparison of the QuickVue One-Step H. pylori II Test to biopsy and to a commercially available EIA was conducted in a multi-center field study. An agreement exceeding 90% was observed.

Physician's Office Laboratory studies were also conducted to show that doctor's office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly. Testing was performed at three geographically distinct sites in the United States. The results obtained at each site agreed 100% with the expected results.

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Conclusion:

: 上一篇: 标签: 标

2017年10月18日 11:00:00

ల్లా ముండి 10 కి.మీ. దూర

r. i

In conclusion, these studies demonstrate the substantial equivalence of the QuickVue One-Step H. pylori II Test to existing products already marketed in the detection of H. pylori specific IgG antibodies. They further demonstrated the suitability of the product for laboratory and professional use. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution.

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized human profiles facing to the right, stacked on top of each other.

AUG - 4 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Robin Weiner Vice President Clinical and Regulatory Affairs Quidel Corporation 10165 McKellar Court San Diego, CA 92121

Re: K991747

Trade Name: QuickVue® One-Step H. Pylori II Test Regulatory Class: I Product Code: LYR Dated: May 20, 1999 Received: May 21, 1999

Dear Ms. Weiner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use (Separate Page): XIII.

of of of 1 -------------------------------------------------------------------------------------------------------------------------------------------------------------------1 -Page Page

510(k) Number (if known):

QuickVue® One-Step H. pylori II Test Device Name:

Indications for Use:

The QuickVue One-Step H. pylori II Test is intended for the rapid, qualitative detection of IgG antibodies specific to Helicobacter pylori in human serum, plasma and whole blood as an aid in the diagnosis of H. pylori infection in patients with clinical signs and symptoms of gastrointestinal disease. The test is intended for use by health care professionals.

(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)	X
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Over-The Counter Use
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(Division Sign-Off)	Woody Dubais
Division of Clinical Laboratory Devices
510(k) Number	K991747

Regulation Number and Section

§ 866.3110

Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter 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.(b)
Classification. Class I (general controls).