INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST by ALFA SCIENTIFIC DESIGNS, INC.

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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Instant-View H. pylori Rapid Test based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance
Sensitivity	High sensitivity to detect H. pylori IgG antibodies	95% (137/144)
Specificity	High specificity to correctly identify absence of H. pylori IgG antibodies	93% (141/152)
Overall Accuracy	High overall accuracy	94% (278/296)
Reproducibility	High intra-assay, inter-assay, and inter-site agreement	Intra-assay: 99.4%-100%; Inter-assay: 99.8%-100%; Inter-site: 99.9%
Interference/Cross-Reactivity	No significant interference or cross-reactivity with common substances or closely related microorganisms	No cross-reaction with Campylobacter fetus, C. jejuni, C. coli, or E. coli. No interference with common serum components (lipids, hemoglobin, bilirubin) or other analytes.
Equivalency across Formats	All device formats (Cassette, Dip Strip, Serum, Whole Blood/Serum) are equivalent in performance	Studies demonstrated all formats are equivalent.

Study Information

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: 296 clinically confirmed serum specimens (144 positive, 152 negative).
Data Provenance: Not explicitly stated (e.g., country of origin). The study states "clinically confirmed serum specimens," implying these were from real patient cases. It is retrospective in the sense that the clinical confirmation (ground truth) was already established for these specimens before testing with the Instant-View device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

The text states "clinically confirmed serum specimens" to establish the ground truth. It does not specify the number or qualifications of experts involved in this clinical confirmation. It implies that standard clinical diagnostic methods were used to determine positive/negative status for H. pylori, but details on the "who" and "how" are not provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

The text does not describe an adjudication method for establishing the ground truth. It simply refers to "clinically confirmed" specimens.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This device is a rapid diagnostic immunoassay and does not involve "readers" in the context of imaging or clinical interpretation by multiple experts that would necessitate an MRMC comparative effectiveness study to assess human-AI interaction. Its performance is evaluated objectively against clinical confirmation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes. The reported sensitivity, specificity, and accuracy are for the device's performance alone when interpreting the sample. There is no human interpretation or intervention in the result generation of the test itself, only in applying the test and reading the final visual line. Therefore, this represents the standalone performance of the device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

"Clinically confirmed" positive and negative H. pylori status for serum specimens. This typically refers to confirmation by established laboratory methods (e.g., endoscopy with biopsy and histology, urea breath tests, stool antigen tests, or other validated serological tests) which serves as the "truth" against which the new device is compared. Specific details are not provided.

8. The sample size for the training set:

The document does not explicitly mention a separate training set for the diagnostic performance evaluation (sensitivity and specificity). For immunoassay devices like this, the 'training' often refers to the internal development and optimization of the assay during the manufacturing process, rather than a distinct dataset used to train an algorithm in the AI sense. The 296 specimens are explicitly referred to as the validation/test set.

9. How the ground truth for the training set was established:

As no explicit training set in the context of an algorithm is mentioned for the performance study, this question is not applicable based on the provided text. For the development of the assay itself, internal R&D processes would involve known positive and negative samples, but these are not typically detailed in 510(k) summaries as "training sets."

Summary

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K024360

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

	Name:	Alfa Scientific Designs, Inc.
Manufacture andsubmitter	Address:	12330 Stowe DrivePoway, CA 92064Telephone: (858) 513-3888 x 308Fax: (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 TestClassification:Campylobacter fetus serological reagents(21 CFR § 866.3110) Class I (reserved)
Date of SummaryPreparation	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 stripin the device consists of 1) a burgundy-colored conjugate padcontaining colloidal gold coupled with H. Pylori antigens, and 2)nitrocellulose membrane containing a test line (T line) and a controlline (C line). The T line is coated with H. Pylori antigens, and the Cline is coated with goat anti-H. Pylori antibodies.
Summary of theSimilarity to thePredicate Device	• Both are one-step lateral-flow chromatographic immunoassays.• Both are intended to provide qualitative detection of IgG antibodiesspecific to H. Pylori.• Both are in vitro diagnostic devices.• Both have a built-in quality control feature, C line, to indicate thatan adequate volume of sample is applied and the device performsproperly

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Intended Use	The Instant-View® H. Pylori Rapid Test is a rapid lateral flow,qualitative immunoassay. It is intended for use at point of carefacilities to detect the presence of IgG antibodies specific toHelicobacter pylori ( H. pylori ) in human blood or serum. It providesan aid in the diagnosis of infection by H. pylori .
Sensitivity and specificitystudy	The sensitivity and specificity of the device was evaluated with 296clinically confirmed serum specimens, 144 positive and 152 negative.The results demonstrated that the Instant-View® H. Pylori Rapid Testhas 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 borderlinepositive and 20 positive serum specimens at three physician's officelaboratories (POL). Each specimen was run in triplicates for threedays at each POL. All the intra-assay agreements were 100% exceptone, which was 99.4%. The inter-assay agreement was 100% at twoPOLs 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 relatedmicroorganisms, such as Campylobacter fetus, Campylobacterjejuni, C. coli , or E. coli at a high concentration.No cross-reaction or interference was observed with endogenoussubstances including common serum components, such as lipids,hemoglobin, bilirubin, and other common biological or chemicalanalytes at a high concentration evaluated.
Formats of the device	The proposed device has two formats: Serum Test and WholeBlood/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 areequivalent.
Conclusion	The results of specificity, sensitivity, reproducibility, cross reactivity,and interference studies demonstrate that the Instant-View® H. PyloriRapid 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 (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

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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:

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)

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

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).