(68 days)
Not Found
No
The description focuses on amperometric biosensor technology and does not mention AI or ML.
No.
Explanation: The device is an in-vitro diagnostic system used for monitoring blood glucose levels, not for treating a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "The MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System is intended for outside-the-body (in-vitro diagnostic) use." highlighting its diagnostic purpose.
No
The device description explicitly states it utilizes "amperometric biosensor technology to generate a current," indicating the presence of hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System is intended for outside-of-the-body (in-vitro diagnostic) use."
N/A
Intended Use / Indications for Use
The MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System is intended for outside-the-body (in-vitro diagnostic) use. The system is indicated for the quantitative measurement of glucose in fresh whole blood for self-testing by lay users (e.g., from the finger), or by health care professionals. The MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System is to be used for the monitoring of blood glucose concentrations in persons with diabetes and other conditions.
Product codes (comma separated list FDA assigned to the subject device)
NBW
Device Description
The MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System for blood glucose testing utilizes amperometric biosensor technology to generate a current. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measure of glucose in whole blood and control solutions.
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
self-testing by lay users (e.g., from the finger), or by health care professionals.
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)
The performance of the MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that lay users can obtain blood glucose results that are substantially equivalent to the current methods for blood glucose measurements, which include the predicate devices listed above.
Results of laboratory and clinical testing demonstrate that the performance of the MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System, when used according to the intended use stated above, is acceptable and comparable to the performance of the previously mentioned predicate devices for blood glucose testing. In addition, results of clinical performance testing demonstrate that trained operators and lay users obtain equivalent whole blood glucose results.
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.
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
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
821
9 2002 SEP
SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitted by: | Janet Connolly, RAC
Sr. Regulatory Affairs Specialist
Abbott Laboratories, MediSense Products
4A Crosby Drive
Bedford, MA 01730-6230 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | MediSense® Precision® Easy / MediSense® OptiumTM Easy Blood
Glucose Monitoring System |
| Common Name: | Self-Monitoring Blood Glucose System |
| Classification: | Glucose Test System
Class II per 21 CFR 862.1345 |
| Predicate Device: | Precision QID® Blood Glucose Testing System, K944195, K971812, |
| Description: | The MediSense Precision Easy / MediSense Optium Easy Blood
Glucose Monitoring System for blood glucose testing utilizes
amperometric biosensor technology to generate a current. The size of
the current is proportional to the amount of glucose present in the
sample, providing a quantitative measure of glucose in whole blood
and control solutions. |
| Intended Use: | The MediSense Precision Easy / MediSense Optium Easy Blood
Glucose Monitoring System is intended for outside-the-body (in-vitro
diagnostic) use. The system is indicated for the quantitative
measurement of glucose in fresh whole blood for self-testing by lay
users (e.g., from the finger), or by health care professionals. |
| Comparison to
Predicate Device: | The MediSense Precision Easy / MediSense Optium Easy Blood
Glucose Monitoring System has equivalent technological
characteristics as the Precision QID Blood Glucose Testing System
(K944195, K971812). The Precision Easy also has the same intended
use as the Precision QID. |
| Performance
Studies: | The performance of the MediSense Precision Easy / MediSense
Optium Easy Blood Glucose Monitoring System was studied in the
laboratory and in clinical settings by healthcare professionals and lay
users. The studies demonstrated that lay users can obtain blood
glucose results that are substantially equivalent to the current methods |
Abbott Laboratories Inc., MediSense Products
1
for blood glucose measurements, which include the predicate devices listed above.
- Results of laboratory and clinical testing demonstrate that the Conclusion: performance of the MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System, when used according to the intended use stated above, is acceptable and comparable to the performance of the previously mentioned predicate devices for blood glucose testing. In addition, results of clinical performance testing demonstrate that trained operators and lay users obtain equivalent whole blood glucose results.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three arms or branches extending upwards.
9 2002 SEP
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Janet Connolly, RAC Sr. Regulatory Affairs Specialist Abbott Laboratories, MediSense Products 4A Crosby Drive Bedford, MA 01730-1402
K022182 Re:
Trade/Device Name: MediSense® Precision® Easy/MediSense® Optium™ Easy Blood Glucose Monitoring System
Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: July 2, 2002 Received: July 3, 2002
Dear Ms. Connolly:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsmaldsmamain.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
4
INDICATIONS FOR USE FORM
510(k) Number (if known): K022182
Device Name:
MediSense® Precision® Easy / MediSense® Optium™ Easy Blood Glucose Monitoring System
Indications For Use:
The MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System is intended for outside-the-body (in-vitro diagnostic) use. The system is indicated for the quantitative measurement of glucose in fresh whole blood for selftesting by lay users (e.g., from the finger), or by health care professionals. The MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System is to be used for the monitoring of blood glucose concentrations in persons with diabetes and other conditions.
Han
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K022182
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(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 801.108) or
Over-The-Counter Use
er Use V
Lian Cooper
(Division Sign-Off) Division of Clinical Laboratory Devices i 510(k) Number_ ( ( 2 ) 2 ) 2 2 2