(58 days)
Not Found
Not Found
No
The summary describes an in-vitro diagnostic test for detecting antibodies and does not mention any AI/ML components or image processing.
No.
The device is an in-vitro diagnostic test, not a therapeutic device. It is intended to aid in the diagnosis of Helicobacter pylori, not to treat the condition.
Yes
The device is described as "an adjunct or aid in the diagnosis of Helicobacter pylori," which directly indicates its diagnostic purpose.
No
The device is described as an "in-vitro qualitative test" performed on an "Automated Instrument," indicating it involves physical reagents and hardware for laboratory analysis, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The Intended Use statement explicitly states: "The HM-CAP™ EIA on the Aptus Automated Instrument is an in-vitro qualitative test..." and "...intended for professional in-vitro use...".
This clearly indicates that the device is designed to be used outside of the body to examine specimens (serum or plasma) for diagnostic purposes.
N/A
Intended Use / Indications for Use
The HM-CAP™ EIA on the Aptus Automated Instrument is an in-vitro qualitative test for the detection of IgG antibodies in serum or plasma in adult symptomatic patients which is intended for professional in-vitro use as an adjunct or aid in the diagnosis of Helicobacter pylori.
Product codes
LYR
Device Description
Not Found
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
adult
Intended User / Care Setting
professional in-vitro use
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
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
FEB 1 8 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Jeffrey Peacock Vice President, Operations Enteric Products Inc. 25 East Loop Drive Stony Brook, New York 11790-3355
K984544 Re: Trade Name: The APTUS (Automated) Application of the HM-CAP EIA Kit Regulatory Class: I Product Code: LYR Dated: December 21, 1998 Received: December 22, 1998
Dear Mr. Peacock:
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 (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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 1 _ of _ 1 _
510 (k) NUMBER (IF KNOWN): ___ K984544
DEVICE NAME: THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT
INDICATIONS FOR USE:
The HM-CAP™ EIA on the Aptus Automated Instrument is an in-vitro qualitative test for the detection of IgG antibodies in serum or plasma in adult symptomatic patients which is intended for professional in-vitro use as an adjunct or aid in the diagnosis of Helicobacter pylori.
Woody Duboes
Division of Clinical Laboratory Devices 510(k) Number _
(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)