BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST by PRINCETON BIOMEDITECH CORP.

BioSign" H. pylori WB qualitatively detects anti-H. pylori antibody in human whole blood, serum or plassua specimens. The test is intended for use in the diagnosis of Helicobacter pylori infection in parients with symptoms of gastrointestinal disorders.

Device Description

Not Found

AI/ML Overview

This document, a 510(k) clearance letter for the BioSign™ H. pylori WB device, primarily focuses on regulatory approval based on substantial equivalence to a predicate device. It does not contain detailed information about specific acceptance criteria, a dedicated study proving device performance against those criteria, or the methodology typically associated with such a study (like sample sizes, expert qualifications, or ground truth establishment).

Therefore, based only on the provided text, I cannot fill out the requested table or answer most of the questions about a device performance study. The letter states that the device "qualitatively detects anti-H. pylori antibody in human whole blood, serum or plasma specimens" and is "intended for use in the diagnosis of Helicobacter pylori infection in patients with symptoms of gastrointestinal disorders." This is the core 'performance' described.

If a study report or clinical data were included as an attachment to this 510(k) submission (which is common), that document would contain the requested information. However, this letter itself does not provide it.

Here's what can be inferred or stated from the provided text:

Device Name: BioSign™ H. pylori WB New One Step anti-H. pylori antibody test
Intended Use: Qualitatively detects anti-H. pylori antibody in human whole blood, serum or plasma specimens. Intended for use in the diagnosis of Helicobacter pylori infection in patients with symptoms of gastrointestinal disorders.
Regulatory Status: Substantially Equivalent to legally marketed predicate devices.

Attempting to answer based on the lack of specific information in the provided document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in this document. Often includes sensitivity, specificity, and accuracy targets.	Detects anti-H. pylori antibody

2. Sample sized used for the test set and the data provenance
* Sample Size (test set): Not mentioned in this document.
* Data Provenance: Not mentioned in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
* Number of Experts: Not mentioned in this document.
* Qualifications: Not mentioned in this document.

4. Adjudication method for the test set
* Adjudication Method: Not mentioned in this document.

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
* MRMC Study: Not mentioned in this document. This device appears to be an in vitro diagnostic test, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to human improvement with AI would not be applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* Standalone Performance: This device is a rapid diagnostic test (implied by "One Step" and "WB" likely meaning "Whole Blood"). Its performance itself is the standalone performance. The document doesn't provide specific standalone performance metrics (e.g., sensitivity, specificity) but rather confirms its regulatory clearance.

7. The type of ground truth used
* Ground Truth Type: Not mentioned in this document. For an H. pylori test, ground truth would typically be established by culture, histology, urea breath test (UBT), or an alternative validated H. pylori test.

8. The sample size for the training set
* Sample Size (training set): Not mentioned in this document. For a rapid diagnostic test like this, the concept of a "training set" in the machine learning sense is not directly applicable. If a training phase was involved in optimizing the assay, details are not provided.

9. How the ground truth for the training set was established
* Ground Truth Establishment (training set): Not mentioned in this document.

Summary of what's provided: The document is a regulatory clearance letter acknowledging substantial equivalence. It confirms the device's intended use and regulatory pathway but does not delve into the detailed performance study data that would have been part of the underlying submission.

Summary

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.

SEP 2 2 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Jemo Kang, Ph.D. Director Princeton BioMeditech Corp. 4242 U.S. Route 1 Monmouth Junction, NJ 08852-1905

K980798 Trade Name: BioSign™ H. pylori WB New One Step anti-H. pylori antibody test Regulatory Class: I Product Code: LYR Dated: July 21, 1998 Received: August 4, 1998

Dear Dr. Kang:

Re:

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.

{1}------------------------------------------------

Page 2

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 Autman

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

{2}------------------------------------------------

Page 1

K980798 5 ! 0(k) Number (if known):

BioSign™ H. gylori NB Device Name:

Indications For Use:

. . . . . . . . ...... . ... . . . .

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------	--

Woody Debars	(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K980798

Professional Use	X
------------------	---

Prescription Use	X
(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).