(21 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, deep learning, image processing, or any other terms typically associated with AI/ML technologies in medical devices. The description focuses on a system for measuring lithium blood levels, which is a standard laboratory technique.
No
The device is intended to measure lithium blood levels, which is a diagnostic function, not a therapeutic one. It aids in the management of a condition but does not directly treat it.
Yes
The device measures lithium blood levels to aid in the management of individuals taking lithium for mental disturbances, which is a diagnostic purpose.
No
The summary describes a "System" intended to "measure lithium blood levels in whole blood". This strongly implies the use of hardware (e.g., a reader, sensor, or analyzer) to perform the measurement, which is not a characteristic of a software-only medical device. The lack of a device description further prevents confirmation of a software-only nature.
Yes, based on the provided information, the InstaRead™ Lithium System is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the system is "intended to measure lithium blood levels in whole blood (fingerstick or venous)." This involves testing a sample taken from the body (blood) outside the body (in vitro) to provide information about a person's health status (lithium levels for managing mental disturbances).
- Anatomical Site: The anatomical site is "whole blood (fingerstick or venous)," which is a biological sample tested in vitro.
These are key characteristics of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The InstaRead™ Lithium System is intended to measure lithium blood levels in whole blood (fingerstick or venous). Measurements of lithium are used to aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder).
Product codes
JIH
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3560 Lithium test system.
(a)
Identification. A lithium test system is a device intended to measure lithium (from the drug lithium carbonate) in serum or plasma. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).(b)
Classification. Class II.
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, with its wings forming three curved lines.
MAR 4 - 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Erika Ammirati Regulatory Consultant Akers Biosciences, Inc. 201 Grove Road Thorofare NJ, 08086
K050338 Re:
Trade/Device Name: InstaRead™ Lithium System Regulation Number: 21 CFR 862.3560 Regulation Name: Lithium test system Regulatory Class: Class II Product Code: JIH Dated: January 31, 2005 Received: February 14, 2005
Dear Ms. Ammirati:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated 776, 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) that do not require approval of a premarket approval application (PMA). and ovening the refore, 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device ican be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
1
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 5 [0(k) I his letter will anow you to ocgin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your premarket notification: "The PDT Intentig sification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, If you desire specific information advertising of your device, please contact the Office of In of questions on the promotion and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may oount outer generational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Jean M. Coogen MS, DUM
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K050338
InstaRead™ Lithium System: Device Name
The InstaRead™ Lithium System is intended to measure Indications For Use: lithium blood levels in whole blood (fingerstick or venous). Measurements of lithium are used to aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder).
Prescription Use __ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol Benson
Division: 3-01
oldsonosile the online and Safety Device I
K05033
Page 1 of 1