(156 days)
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No
The summary describes a simple immunoassay and contains no mention of AI, ML, or related concepts.
No
The device is an in vitro diagnostic immunoassay used for qualitative detection of H. pylori antibodies, aiding in diagnosis rather than providing treatment. It is explicitly stated as "FOR IN VITRO DIAGNOSTIC USE."
Yes.
The "Intended Use / Indications for Use" section states: "FOR IN VITRO DIAGNOSTIC USE." and "It is intended for use as an aid to diagnosis of H. pylori infection".
No
The device description explicitly states it is a "colloidal-gold based immunoassay," which is a physical test kit, not software.
Yes, the device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "FOR IN VITRO DIAGNOSTIC USE." This is the primary indicator that the device is an IVD.
Furthermore, the description of the device and its intended use aligns with the definition of an IVD:
- It is used to test human specimens (whole blood or serum).
- It is used to detect a specific substance (circulating IgG antibody to Helicobacter pylori).
- It is intended to provide information for the diagnosis of a condition (H. pylori infection).
- It is intended for use in a clinical laboratory or physician's office setting.
N/A
Intended Use / Indications for Use
Stat-Simple™ pylori is a colloidal-gold based immunoassay for use in the qualitative detection of circulating IgG antibody to Helicobacter pylori in whole blood or serum. The blood specimen may be obtained by fingerstick using a lancet designed for that purpose. This test is intended for use in the clinical laboratory or the physician's office. This test is intended for use as an aid to diagnosis of H. pylori infection in persons with gastrointestinal symptoms consistent with diseases related to H. pylori infection (1). FOR IN VITRO DIAGNOSTIC USE.
Product codes
LYR
Device Description
Stat-Simple™ pylori is a colloidal-gold based immunoassay for use in the qualitative detection of circulating IgG antibody to Helicobacter pylori in whole blood or serum.
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
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Intended User / Care Setting
clinical laboratory or the physician's office
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG - 5 1998
Paul D. Slowey, Ph.D. Chief Operating Officer Saliva Diagnostic System 11719 NE 95th Street, Suite A Vancouver, WA 98682
K980782 Re: Trade Name: Stat-Simple Pylori Regulatory Class: I Product Code: LYR Dated: May 22, 1998 Received: May 27, 1998
Dear Mr. Slowey:
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 (OS) 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 Butman
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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Page / of /
510(k) Number (if known): K980782
Stat.Simple™ pylori Device Name:_
Indications For Use:
Stat-Simple™ pylori is a colloidal-gold based immunoassay for use in the qualitative decedion of Stat-Simple - pyrori is a conoma-gota vason inimale blood or serum. The blood speciment circulating ig antibody to Trencoucic: pyric I lancet designed for that purpose. This test is intended for use intended for use in the clinical laboratory or the physician's offices is intended for use as
intended for use in the clinical laboratory or the physician systems synntoms co mended for use in the Childed and cated on in persons with gastrointestinal symptoms consistent
an aid to diagnosis of H. pylori infection in persons with gastronomia CNA CNO with diseases related to H. pylor infection (1). FOR IN VITRO DIAGNOSTIC USE.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Clinid al Laboratory Devices 510(k) Number_K 980782 Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)