(84 days)
Not Found
No
The summary describes a standard blood glucose testing system using amperometric biosensor technology, with no mention of AI or ML capabilities.
No
This device is an in vitro diagnostic (IVD) tool used for measuring blood glucose levels, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "intended for in vitro diagnostic use".
No
The device description explicitly mentions "Blood Glucose Test Strips" which utilize "amperometric biosensor technology" to measure glucose. This indicates a physical component (the test strip) is integral to the device's function, making it a hardware-based medical device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The Precision QID Blood Glucose Testing System is intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh capillary whole blood."
- "The Precision G Blood Glucose Testing System is intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh whole capillary blood."
This language clearly identifies the device as an IVD.
N/A
Intended Use / Indications for Use
The Precision QID Blood Glucose Testing System is intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. For home or professional use with the Precision QID Blood Glucose Sensor. Compatible with the MediSense 2 Card and Pen Blood Glucose Sensors, and the Companion 2 Card and Pen Blood Glucose Sensors. The product may also be used by healthcare professionals for the quantitative measurement of glucose in venous, arterial, or neonate whole blood, provided the sample is used within 30 minutes of collection.
The Precision G Blood Glucose Testing System is intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh whole capillary blood. The Precision G Blood Glucose Testing System is intended for home or professional use.
Product codes (comma separated list FDA assigned to the subject device)
CGA
Device Description
The Precision QID and Precision G Blood Glucose Test Strips are identical in test strip design. Both test strips utilize amperometric biosensor technology to quantitatively measure glucose in whole blood and control solutions. The Precision QID Blood Glucose Test Strips are for use with the Precision QID Blood Glucose Testing System and are also compatible with the MediSense 2 Card and Pen Blood Glucose Testing Systems. The Precision G Blood Glucose Test Strip is only for use with the Precision G Blood Glucose Testing System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home or professional 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the Precision QID and Precision G Test Strip 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.)
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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.
K945887, K962295, K963676, K951887, K954833
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.
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AUG - 8 1997
1971812
Summary of Safety and Effectiveness
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| Submitted by: | Michael Halpin
Manager of Regulatory Affairs
MediSense, Inc.
4A Crosby Drive
Bedford MA 01730 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Precision QID® and Precision G Blood Glucose Test Strip |
| Common Name: | Reagent test strips for Blood Glucose |
| Classification: | "Glucose Test System" - Class II per CFR 862.1345 |
| Predicate Devices: | Precision QID® Blood Glucose Test Strip - K945887, K962295
Precision G Blood Glucose Testing System - K963676
Accu-Chek Advantage Test Strips - K951887, K954833 |
| Description: | The Precision QID and Precision G Blood Glucose Test Strips are
identical in test strip design. Both test strips utilize amperometric
biosensor technology to quantitatively measure glucose in whole blood
and control solutions. The Precision QID Blood Glucose Test Strips
are for use with the Precision QID Blood Glucose Testing System and
are also compatible with the MediSense 2 Card and Pen Blood Glucose
Testing Systems. The Precision G Blood Glucose Test Strip is only for
use with the Precision G Blood Glucose Testing System. |
| Intended Use: | The Precision QID Blood Glucose Testing System is intended for in
vitro diagnostic use (i.e., for external use only) for the quantitative
measurement of glucose in fresh capillary whole blood. For home or
professional use with the Precision QID Blood Glucose Sensor.
Compatible with the MediSense 2 Card and Pen Blood Glucose
Sensors, and the Companion 2 Card and Pen Blood Glucose Sensors.
The product may also be used by healthcare professionals for the
quantitative measurement of glucose in venous, arterial, or neonate
whole blood, provided the sample is used within 30 minutes of
collection.
The Precision G Blood Glucose Testing System is intended for in vitro
diagnostic use (i.e., for external use only) for the quantitative
measurement of glucose in fresh whole capillary blood. The Precision
G Blood Glucose Testing System is intended for home or professional
use. |
| Comparison to
Predicate Device: | The proposed Precision QID and Precision G Blood Glucose Test Strip
have technological characteristics equivalent to those of the predicate
Precision QID Blood Glucose Test Strip (K945887, K962295) and
predicate Precision G Blood Glucose Testing System (K963676). The
proposed Precision QID and Precision G Test Strip is comparable in
form, function, material composition, manufacturing process, and
intended use to the predicate Precision QID Test Strip and Precision G
Test Strip. In addition the intended use for the proposed Precision
QID and Precision G Test Strip is identical to the intended use of
another predicate device, the Accu-Chek Advantage Test Strip
(K951887, K954833). |
| Performance
Studies: | The performance of the Precision QID and Precision G Test Strip 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 QID and Precision G Blood Glucose Test
Strip when used according to the intended use stated above is
acceptable and comparable to the performance of the predicate devices
including the Precision QID Blood Glucose Test Strip (K945887,
K962295), the Precision G Blood Glucose Testing System (K963676),
and the Accu-Chek Advantage Test Strip (K951887, K954833). |
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design that resembles an abstract caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG - 8 1997
Mr. Michael G. Halpin · Manaqer Requlatory Affairs and Compliance -----Medisense, Inc. 4A Crosby Drive Bedford, MA 01730
Re : K971812/S001 Precision QID® and Precision G Blood Glucose Test Strip Requlatory Class: II Product Code: CGA Dated: July 31, 1997 Received: August 4, 1997
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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to 895. ಗ್ಗ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 In addition, FDA may publish further announcements action. 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 Requlations.
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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 qeneral 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/dsmamain.html".
Sincerely yours,
Steven Sitman
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): K945887; K962295
Device Name: Precision QID Blood Glucose Testing System
Indications For Use:
The Precision QID Blood Glucose Testing System is intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. For home or professional use with the Precision QID Blood Glucose Sensor. Compatible with the MediSense 2 Card and Pen Blood Glucose Sensors, and the Companion 2 Card and Pen Blood Glucose Sensors.
The product may also be used by healthcare professionals for the quantitative measurement of glucose in venous, arterial, or neonate whole blood, provided the sample is used within 30 minutes of collection.
(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)
OL
Over-The-Counter Use
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number k97,812