(93 days)
Not Found
No
The device description and performance studies describe a lateral flow immunoassay, which is a traditional diagnostic technology and does not mention any AI or ML components.
No.
The device is described as a diagnostic tool for detecting antibodies to H. pylori, not a device used for therapy or treatment.
Yes
The Intended Use section states that the device is "to aid in the diagnosis of H. pylori infection."
No
The device description clearly states it is a "lateral flow immunochromatographic assay" and a "rapid test strip and test device," which are physical hardware components used for qualitative detection of antibodies. It also mentions it can be performed "without the use of an instrument," further indicating it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's 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". This clearly indicates it's used to test samples taken from the human body in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details a "lateral flow immunochromatographic assay" that detects antibodies in "whole blood, serum or plasma". This further confirms it's a test performed on biological samples.
- Performance Studies: The performance studies involve testing "clinical specimens" (human samples) and comparing the results to other diagnostic methods (Culture/Histology, Rapid Urease Test). This is typical for evaluating the performance of an IVD.
The core function of the device is to analyze biological samples in vitro to provide information for diagnosing a medical condition, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
LYR
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults 18 years of age and older
Intended User / Care Setting
health professionals and professionals at point-of-care sites.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical and laboratory studies were conducted to compare the ACON® H. pylori Rapid Test Strip and Test Device against predicate devices (QuickVue One-Step H. pylori gII Test and Beckman Coulter FlexSure HP Test) and against Culture/Histology and Histology/Rapid Urease Test as reference methods.
ACON® H. pylori Rapid Test Strip compared to Quidel QuickVue One-Step H. pylori gII Test (sample size: 200, based on summing positive and negative agreements): 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 Strip compared to Beckman Coulter FlexSure HP (sample size: 163): 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 (sample size: 321): 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 (sample size: 163): 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 (sample size: 200): 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 (sample size: 163): 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 (sample size: 321): Sensitivity = 121/136 = 89% (82%-94%), Specificity = 164/185 = 89% (83%-93%), Accuracy = 285/321 = 89% (85%-92%).
ACON H. pylori Rapid Test Device compared to Histology/Rapid Urease Test (sample size: 163): Sensitivity = 52/71 = 73% (61%-83%), Specificity = 76/92 = 83% (73%-90%), Accuracy = 128/163 = 78% (71%-84%).
Conclusion: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
ACON® H. pylori Rapid Test Strip compared to Culture/Histology:
Sensitivity = 88% (82%-93%)
Specificity = 89% (83%-93%)
Accuracy = 88% (84%-92%)
ACON® H. pylori Rapid Test Strip compared to Histology/Rapid Urease Test:
Sensitivity = 70% (58%-81%)
Specificity = 86% (77%-92%)
Accuracy = 79% (72%-85%)
ACON H. pylori Rapid Test Device compared to Culture/ Histology:
Sensitivity = 89% (82%-94%)
Specificity = 89% (83%-93%)
Accuracy = 89% (85%-92%)
ACON H. pylori Rapid Test Device compared to Histology/Rapid Urease Test:
Sensitivity = 73% (61%-83%)
Specificity = 83% (73%-90%)
Accuracy = 78% (71%-84%)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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 |
| blood, serum or plasma | |
| Test Category: | Manual procedures with limited steps and limited sample |
| 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
Test Strip | ACON® H. pylori Rapid Test
Device | Quidel QuickVue One-
Step H. pylori gII |
|---------|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | | | |
| | Indication
for
use | A rapid chromatographic
immunoassay for the
qualitative detection of
antibodies to Helicobacter
pylori in whole blood to aid in
the diagnosis of H. pylori
infection. | A rapid chromatographic
immunoassay for the qualitative
detection of antibodies to
Helicobacter pylori in whole blood
to aid in the diagnosis of H. pylori
infection. |
| | Intended Use | Professional | Professional |
| | Intended
specimen | Whole blood, serum, plasma | Whole blood, serum, plasma |
| | Endpoint | Colored Lines | Colored Lines |
| | Materials
provided | Test strips
Disposable sample test tubes
Disposable droppers
Capillary tube
Dispensing bulb
Positive control
Negative control
Buffer
Package insert
Procedure card | Test devices
Disposable droppers
Capillary tube
Dispensing bulb
Positive control
Negative control
Buffer
Package insert
Procedure card |
| | Methodology | Membrane particle assay | Membrane particle assay |
| | Test Time | 10 minutes | 10 minutes |
| | Format | Antigen/antibody
immunoassay | Antigen/antibody immunoassay |
3
ACON H. pylori Tests versus Beckman Coulter FlexSure HP (K934863)
| | ACON® H. pylori Rapid
Test Strip | ACON® H. pylori Rapid Test
Device | Beckman Coulter
FlexSure HP |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | | | |
| Indication for use | A rapid chromatographic
immunoassay for the
qualitative detection of
antibodies to Helicobacter
pylori in whole blood to aid in
the diagnosis of H. pylori
infection. | A rapid chromatographic
immunoassay for the qualitative
detection of antibodies to
Helicobacter pylori in whole blood
to aid in the diagnosis of H. pylori
infection. | A rapid, visually read,
qualitative
immunochromato-
graphic method for the
detection of IgG
antibodies to H. pylori in
serum as an aid in the
diagnosis of H. pylori
infection in patients with
clinical signs and
symptoms of
gastrointestinal disease is
not intended for use with
asymptomatic patients. |
| Intended Use | Professional | Professional | Professional |
| Intended
specimen | Whole blood, serum, plasma | Whole blood, serum, plasma | Serum |
| Endpoint | Colored Lines | Colored Lines | Colored Lines |
| Materials
provided | Test strips
Disposable sample test tubes
Disposable droppers
Capillary tube
Dispensing bulb
Positive control
Negative control
Buffer
Package insert
Procedure card | Test devices
Disposable droppers
Capillary tube
Dispensing bulb
Positive control
Negative control
Buffer
Package insert
Procedure card | Test cards
Disposable transfer
pipettes
Capillary tube
Buffer
Product Instructions |
| Methodology | Membrane particle assay | Membrane particle assay | Membrane particle assay |
| Test Time | 10 minutes | 10 minutes | 4 minutes |
| Format | Antigen/antibody
immunoassay | Antigen/antibody immunoassay | Antigen/antibody
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.
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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).
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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