(162 days)
Not Found
No
The device description and performance studies describe a standard lateral flow immunoassay, with no mention of AI or ML technologies.
No
Explanation: This device is for diagnosis (detecting antibodies to H. Pylori) and does not treat or cure a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "provides an aid in the diagnosis of infection by H. pylori."
No
The device description clearly indicates it is a physical lateral flow immunoassay test strip, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is intended for use "to detect the presence of IgG antibodies specific to Helicobacter pylori (H. pylori) in human blood or serum." This is a classic definition of an in vitro diagnostic test, as it analyzes biological samples (blood or serum) outside of the body to provide information about a person's health status (presence of H. pylori infection).
- Purpose: The intended use also states that it "provides an aid in the diagnosis of infection by H. pylori." This further confirms its role in the diagnostic process, which is a core function of IVDs.
- Device Description: The description details a "lateral flow chromatographic immunoassay," which is a common technology used in many IVD tests.
- Performance Studies: The document includes details about performance studies (sensitivity, specificity, reproducibility, interference, and cross-reactivity) conducted using human specimens. This type of testing is required for IVD devices to demonstrate their accuracy and reliability.
- Predicate Devices: The mention of predicate devices (K984393 and K990892) indicates that this device is being compared to other legally marketed IVD devices for the same purpose.
All of these elements strongly indicate that the Instant-View H. Pylori Rapid Test is an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LYR
Device Description
A one-step lateral flow chromatographic immunoassay. The test strip in the device consists of 1) a burgundy-colored conjugate pad containing colloidal gold coupled with H. Pylori antigens, and 2) nitrocellulose membrane containing a test line (T line) and a control line (C line). The T line is coated with H. Pylori antigens, and the C line is coated with goat anti-H. Pylori antibodies.
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
This test has been evaluated for use with serum specimens of adults, 19 years and older.
Intended User / Care Setting
point of care facilities
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
The sensitivity and specificity of the device was evaluated with 296 clinically confirmed serum specimens, 144 positive and 152 negative.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Sensitivity and specificity study: The sensitivity and specificity of the device was evaluated with 296 clinically confirmed serum specimens, 144 positive and 152 negative. The results demonstrated that the Instant-View® H. Pylori Rapid Test has a sensitivity of 95%( 137/144) and a specificity of 93%( 141/152). The overall accuracy of this device is 94% (278/296).
Reproducibility study: Reproducibility studies were performed on 20 negative, 20 borderline positive and 20 positive serum specimens at three physician's office laboratories (POL). Each specimen was run in triplicates for three days at each POL. All the intra-assay agreements were 100% except one, which was 99.4%. The inter-assay agreement was 100% at two POLs and 99.8% at one. The inter-site agreement was 99.9%.
Interference and cross-reactivity study: No cross-reaction was observed with the closely related microorganisms, such as Campylobacter fetus, Campylobacter jejuni, C. coli, or E. coli at a high concentration. No cross-reaction or interference was observed with endogenous substances including common serum components, such as lipids, hemoglobin, bilirubin, and other common biological or chemical analytes at a high concentration evaluated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 95%( 137/144)
Specificity: 93%( 141/152)
Overall accuracy: 94% (278/296)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary Safety and Effectiveness as Required by 21 CFR 807.92
| Name: | Alfa Scientific Designs, Inc. | |
|---|---|---|
| Manufacture and | ||
| submitter | Address: | 12330 Stowe Drive |
| Poway, CA 92064 | ||
| Telephone: (858) 513-3888 x 308 | ||
| Fax: (858) 513-8388 | ||
| Contact Person: | Naishu Wang, MD, Ph.D. | |
| E-mail: | wnss@alfascientific.com | |
| Trade 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) | ||
| Device Name | Common Name: | |
| Immunoassay, H. Pylori Test | ||
| Classification: | ||
| Campylobacter fetus serological reagents | ||
| (21 CFR § 866.3110) Class I (reserved) | ||
| Date of Summary | ||
| Preparation | June 9, 2003 | |
| Predicate Device | SureStep™ H. Pylori Test, Applied Biotech, Inc. | |
| K984393 (Serum and Plasma), K990892 (Whole Blood) | ||
| Device Description | A one-step lateral flow chromatographic immunoassay. The test strip | |
| in the device consists of 1) a burgundy-colored conjugate pad | ||
| containing colloidal gold coupled with H. Pylori antigens, and 2) | ||
| nitrocellulose membrane containing a test line (T line) and a control | ||
| line (C line). The T line is coated with H. Pylori antigens, and the C | ||
| line is coated with goat anti-H. Pylori antibodies. | ||
| Summary of the | ||
| Similarity to the | ||
| Predicate Device | • Both are one-step lateral-flow chromatographic immunoassays. | |
| • Both are intended to provide qualitative detection of IgG antibodies | ||
| specific to H. Pylori. | ||
| • Both are in vitro diagnostic devices. | ||
| • Both have a built-in quality control feature, C line, to indicate that | ||
| an adequate volume of sample is applied and the device performs | ||
| properly |
1
| Intended 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 . |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sensitivity and specificity
study | The sensitivity and specificity of the device was evaluated with 296
clinically confirmed serum specimens, 144 positive and 152 negative.
The results demonstrated that the Instant-View® H. Pylori Rapid Test
has a sensitivity of 95%( 137/144) and a specificity of 93%( 141/152).
The overall accuracy of this device is 94% (278/296). |
| Reproducibility study | Reproducibility studies were performed on 20 negative, 20 borderline
positive and 20 positive serum specimens at three physician's office
laboratories (POL). Each specimen was run in triplicates for three
days at each POL. All the intra-assay agreements were 100% except
one, which was 99.4%. The inter-assay agreement was 100% at two
POLs and 99.8% at one. The inter-site agreement was 99.9%. |
| Interference and cross-
reactivity study | No cross-reaction was observed with the closely related
microorganisms, such as Campylobacter fetus, Campylobacter
jejuni, C. coli , or E. coli at a high concentration.
No cross-reaction or interference was observed with endogenous
substances including common serum components, such as lipids,
hemoglobin, bilirubin, and other common biological or chemical
analytes at a high concentration evaluated. |
| Formats of the device | The proposed device has two formats: Serum Test and Whole
Blood/Serum Test, and the Serum Test has two sub-formats:
Cassette and Dip-Strip. A cassette is a device that assembles a dip-
strip in a plastic housing. The studies demonstrate all the formats are
equivalent. |
| Conclusion | The results of specificity, sensitivity, reproducibility, cross reactivity,
and interference studies demonstrate that the Instant-View® H. Pylori
Rapid Test is substantially equivalent to the predicate device. |
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, with three overlapping profiles suggesting community and support. The figure is abstract and uses flowing lines to create a sense of movement and connection.
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 (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
4
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)