(204 days)
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Not Found
No
The summary describes a qualitative immunoassay for detecting antibodies, which is a standard laboratory technique and does not mention any AI/ML components or image processing.
No
The device is a diagnostic tool that detects antibodies for H. pylori infection, not a device that treats or prevents a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the test is "intended for use in the diagnosis of Helicobacter pylori infection."
No
The device is a qualitative test detecting antibodies in biological specimens (whole blood, serum, or plasma). This indicates a physical test kit or assay, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device "qualitatively detects anti-H. pylori antibody in human whole blood, serum or plasma specimens." This involves testing biological samples taken from the human body in vitro (outside the body).
- Diagnosis: The intended use also states that the test is "intended for use in the diagnosis of Helicobacter pylori infection." IVDs are used to provide information for the diagnosis of diseases or conditions.
These two points clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BioSign™ H. pylori WB qualitatively detects anti-H. pylori antibody in human whole blood, serum or plasma specimens. The test is intended for use in the diagnosis of Helicobacter pylori infection in patients with symptoms of gastrointestinal disorders.
Product codes
LYR
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional Use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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/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.
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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 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
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K980798 5 ! 0(k) Number (if known):
BioSign™ H. gylori NB Device Name:
Indications For Use:
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.
. . . . . . . . ...... . ... . . . .
(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) |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |