(495 days)
Not Found
Not Found
No
The provided 510(k) summary contains no information about the device description, intended use, or any mention of AI, ML, or related concepts.
No
The provided information is all "Not Found," so there is no basis to determine if the device is therapeutic.
No
The provided information indicates "Not Found" for "Intended Use / Indications for Use" and "Device Description," which are typically key sections for determining if a device is diagnostic. Without this information, there's no basis to confirm it's a diagnostic device.
Unknown
The provided 510(k) summary is completely empty, offering no information about the device's nature, components, or function. Therefore, it's impossible to determine if it's a software-only medical device.
Based on the information provided, it is impossible to determine if this device is an IVD.
The document contains "Not Found" for all the key sections that would typically describe a medical device, including its intended use, description, and any mention of diagnostic processes.
To determine if it's an IVD, you would need information about:
- Intended Use: Does it analyze samples taken from the human body (like blood, urine, tissue)?
- Device Description: What does the device actually do?
- Any mention of diagnostic testing: Does it perform tests to diagnose diseases or conditions?
Without any of this information, we cannot classify the device.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
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
Not Found
Intended User / Care Setting
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 17 1996
Ms. Claudia T. Hitchcock Meretek Diagnostics, Inc. 1709 Dryden Road Suite 1513 Houston, Texas 77030
K952220 Re: MERETEK UBT™ Regulatory Class: I Product Code: LYR Dated: June 28, 1996 Received: June 28, 1996
Dear Ms. Hitchcock:
We have reviewed your Section 510(k) notification of intent to market the device referenced we and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good provisions of the rise mond labeling, and prohibitions against misbranding and adulteration.
In addition, we have determined that your product contains the following component subject to regulation as drugs: Pranactin™ (13C-Urea-125 mg).
Our substantially equivalent determination does not apply to the drug component (NDA 20-586) of your product. For information on applicable Agency requirements for marketing this product, we suggest you contact:
David W. Feigal, Jr., M.D., M.P.H. Acting Director Office of Drug Evaluation IV Center for Drug Evaluation and Research Food and Drug Administration 9201 Corporate Boulevard Rockville, Maryland 20850 (301) 827-2120
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 (1 remations 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
1
Page 2 - Ms. Claudia T. Hitchcock
Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR)
Concessed and Charles (2) CMD increases (EDA will verify such assumptions Good Manufacturing Practic GMP inspections, FDA will verity ouch assumptions.
Part 820) and that, through periodic GMP inspections, FDA will verily onch assumptions. In addit Part 820) and that, through periodic GMP regulation may result in regulatory action. In addition,
Failure to comply with the GMP regulation may result in regulation. In add Failure to comply with the GMP regulation in regulation and oncernents concerning
the Food and Drug Administration (FDA) may publish further announcements on the Food and Drug Administration (FDA) now publish response to your premarket your device in the Federal Register. Please into response as you might have under section 531
notification submission does not affect any obligation you might tadjation Contr notification submission does not any bollgator you the games and the electronic Radiation Control
through 542 of the Act for devices under the Electronic Product Radiation Co through 542 of the Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k)
The Center for the first be areasmmend that you first contact the Center for D This letter will allow you to begin marketing your devices the Center for Drug
premarket notification although we recommend that you first comtact the Center of premarket notification although we recomment. An FDA finding of
Evaluation and Research before marketing your drug components in Evaluation and Research before marketing your ung componence device results in a
substantial equivalence of your device to a legally market, but it do substantial equivalence of your device to a legally inanced pleated to the market, but it does
classification for your device and permiss your device or in any way classification for your device and permits your cever, you may not promote or in any way
not mean that FDA approves your device annoved by FDA . If you desire specific not mean that FDA approves your device. Thereview by FDA. If you desire specific represent your device or its labeling regulation (21 CFR Part 801 and additionally 809.10
advice for your device on the labeling regulation (21 CFR Part 801 and additionally advice for your device on the labeling regulation (21 Circle ocontact the Office of
for in vitro diagnostic devices), promotion, or advertising, please contact the Office of for in vitro diagnostic devices), promotion, or are crising, productions.
Compliance, Promotion and Advertising Policy Staff (HFZ-302) at (301) 594-4639. Other Compliance, Promotion and Advertisibilities under the Act may be obtained from the general information on your responsibilities under the Act Hay 90 Count.
Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
a. Ditran
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health