(160 days)
Not Found
No
The summary describes a standard glucose meter using amperometric biosensor technology, with no mention of AI, ML, or related concepts.
No
This device is for in vitro diagnostic use, meaning it measures glucose levels in blood samples for diagnostic purposes, rather than directly treating or preventing a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the in vitro diagnostic use."
No
The device description explicitly mentions "amperometric biosensor technology" and the measurement of glucose in "fresh capillary whole blood," indicating the use of physical hardware components (test strips, meter) to perform the measurement. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "The Precision G Plus Point of Care Management System for Blood Glucose is intended for the in vitro diagnostic use (i.e. for external use only) for the quantitative measurement of glucose in fresh capillary whole blood."
- Measurement of Analytes in Biological Samples: The device measures glucose, which is an analyte, in biological samples (whole blood). This is a core function of IVD devices.
- Purpose of Diagnosis/Monitoring: While not explicitly stating "diagnosis," the measurement of blood glucose is a fundamental tool for monitoring and managing conditions like diabetes, which falls under the scope of IVD use.
The other sections of the document further support this by describing the technology used to measure the analyte and the intended users and settings, all consistent with an IVD device.
N/A
Intended Use / Indications for Use
The Precision·G Plus Point of Care Management System is intended for the in vitro diagnostic use (i.e. for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The Precision·G Plus Point of Care Management System is for home (lay user) or professional use.
The product may also be used by healthcare professionals for the quantitative measurement of glucose in venous, arterial or neonatal whole blood, provided the sample is used within 30 minutes.
Product codes
CGA
Device Description
The Precision·G Plus Point of Care Management 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
home (lay user) or professional use.
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)
The performance of the Precision G Point of Care Management System was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that user can obtain blood glucose results that are substantially equivalent to the current methods for blood glucose measurement including the predicate devices named above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K963676, K944195, K945887, K962295, K971812, K970556
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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;
Summary of Safety and Effectiveness
| Submitted by: | Michael Halpin
Manager, Regulatory Affairs and Quality Systems
MediSense, Incorporated
4A Crosby Drive
Bedford, Massachusetts 01730 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Precision·G Plus Point of Care Management System
for Blood Glucose Testing |
| Common Name: | Blood Glucose Testing System |
| Classification: | Glucose Test System
Class II per 21 CFR 862.1345 |
| Predicate Devices: | Precision·G® Blood Glucose Testing System--K963676
Precision QID® Blood Glucose Testing System--K944195
Precision QID® and Precision·G® Blood Glucose Test Strip--
K945887, K962295, K971812
Johnson and Johnson Surestep Pro System -- K970556 |
| Description: | The Precision·G Plus Point of Care Management 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 Precision·G Plus Point of Care Management System is intended
for the in vitro diagnostic use (i.e. for external use only) for the
quantitative measurement of glucose in fresh capillary whole blood.
The Precision·G Plus Point of Care Management System is for
home (lay user) or professional use. |
| | The product may also be used by healthcare professionals for the
quantitative measurement of glucose in venous, arterial or neonatal
whole blood, provided the sample is used within 30 minutes. |
| Comparison to
Predicate Device: | The proposed Precision·G Plus Point of Care Management System
has equivalent technological characteristics and the same intended
use as both the Precision·G® Blood Glucose Testing System
(K963676, K971812) and the Precision QID® Blood Glucose
Testing System (K944195, K971812). In addition, the Precision·G
Plus Point of Care Management system is substantially equivalent |
| | |
| | to an additional competitive predicate device, the Johnson and
Johnson Surestep Pro Blood Glucose Monitoring System
(K970556). |
| Performance
Studies: | The performance of the Precision G Point of Care Management
System was studied in the laboratory and in clinical settings by
healthcare professionals and lay users. The studies demonstrated
that user can obtain blood glucose results that are substantially
equivalent to the current methods for blood glucose measurement
including the predicate devices named above. |
| Conclusion: | Results of laboratory and clinical testing demonstrate that the
performance of the Precision G Point of Care Management system
when used according to the intended use stated above is acceptable
and comparable to the performance of the predicate devices
mentioned above. |
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and 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 image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Michael Halpin DEC 8 1998 Manager, Requlatory Affairs and Quality Systems MediSense, Incorporated 4A Crosby Drive Bedford, Massachusetts 01730
K982303 Re: Precision-G Plus Point of Care Management System for Trade Name: Blood Glucose Testing Requlatory Class: II Product Code: CGA Dated: June 30, 1998 Received: July 1, 1998
Dear Mr. Halpin:
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 requlations 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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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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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 Putman
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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INDICATIONS FOR USE FORM
510(k) Number (if known):
Device Name: Precision G Plus Point of Care Management System for Blood Glucose
Indications For Use:
The Precision G Plus Point of Care Management System for Blood Glucose is intended for the in vitro diagnostic use (i.e. for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The Precision. G Plus Point of Care Management System is for home (lay user) or professional use.
The product may also be used by healthcare professionals for the quantitative measurement of glucose in venous, arterial or neonatal whole blood, provided the sample is used within 30 minutes.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrent of CDRH, Office of Device Evaluation (ODE) L Over-The-Counter Use Prescription Use Or (Per 21 CFR 801.108) (Division Sign-Off) Division of Clinical Labo
510(k) Number .