(84 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Precision QID® and Precision G Blood Glucose Test Strips:
Overview
The provided document is a 510(k) Summary of Safety and Effectiveness for the Precision QID® and Precision G Blood Glucose Test Strip. It seeks substantial equivalence to previously cleared predicate devices. The primary focus of the performance studies is to demonstrate that the new device is "substantially equivalent" to existing methods for blood glucose measurement.
Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" in the format typically seen with accuracy or precision targets (e.g., "95% of results within ±X% of reference"). Instead, the acceptance criterion is implicitly framed within the context of substantial equivalence to predicate devices. The reported device performance is qualitative:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence to current methods for blood glucose measurement, including predicate devices: Precision QID Blood Glucose Test Strip (K945887, K962295), Precision G Blood Glucose Testing System (K963676), and Accu-Chek Advantage Test Strips (K951887, K954833). This implies that the new device should provide glucose results comparable in accuracy and reliability to these established devices across various user groups (healthcare professionals and lay users) and sample types (capillary, venous, arterial, neonate whole blood). The statement also notes comparable form, function, material composition, manufacturing process, and intended use. | "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.""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..." |
Study Details
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Sample Size used for the test set and the data provenance:
- The document states that the performance was studied "in the laboratory and in clinical settings by healthcare professionals and lay users."
- Specific sample sizes are NOT provided.
- Data Provenance: Not explicitly stated, but clinical settings by "healthcare professionals and lay users" suggests data was collected from human subjects, likely in the US where the submission originated. It is a prospective study as it's evaluating the performance of the new device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for this type of device. For blood glucose meters, the "ground truth" or reference method is typically an established laboratory-based glucose analyzer, not expert consensus on image interpretation. The document doesn't specify the reference method used, but it would almost certainly be a highly accurate lab instrument.
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Adjudication method for the test set:
- Not applicable. Adjudication is typically used to resolve discrepancies among human readers or to establish ground truth in subjective assessments (e.g., image interpretation). This is a quantitative measurement device (blood glucose), where performance is compared directly to a reference method, not an adjudicated human reading.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a standalone diagnostic device for measuring blood glucose, not an AI-assisted interpretation tool for human readers. Therefore, an MRMC study is not relevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in essence. The evaluation described is of the device itself (the test strip and its associated meter system) against a reference method. While human users (healthcare professionals and lay users) operate the device, the performance being assessed is the quantitative output of the device, which is a "standalone" measurement by the instrument based on its internal algorithm/chemistry. The study is assessing the device's ability to accurately measure glucose, independent of human interpretation of complex data.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document implies that the ground truth was established by "current methods for blood glucose measurement," which almost certainly refers to a laboratory reference method (e.g., a glucose analyzer like a YSI analyzer), known for its high accuracy and precision.
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The sample size for the training set:
- Not explicitly stated and not directly applicable in the AI/machine learning sense. This device is based on amperometric biosensor technology, which relies on chemical reactions and electrochemical detection, not a machine learning model that requires a "training set" in the computational sense. While the device's development and calibration would involve extensive testing and refinement with many samples, this isn't referred to as a "training set" in the context of this 510(k) summary.
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How the ground truth for the training set was established:
- Not applicable for a "training set" in the AI/ML sense. For the development and calibration of such a biosensor, the "ground truth" for establishing the device's performance characteristics (e.g., sensitivity, linearity, accuracy) would be established using precisely measured glucose solutions and/or blood samples analyzed by highly accurate laboratory reference methods.
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AUG - 8 1997
1971812
Summary of Safety and Effectiveness
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| Submitted by: | Michael HalpinManager of Regulatory AffairsMediSense, Inc.4A Crosby DriveBedford 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, K962295Precision G Blood Glucose Testing System - K963676Accu-Chek Advantage Test Strips - K951887, K954833 |
| Description: | The Precision QID and Precision G Blood Glucose Test Strips areidentical in test strip design. Both test strips utilize amperometricbiosensor technology to quantitatively measure glucose in whole bloodand control solutions. The Precision QID Blood Glucose Test Stripsare for use with the Precision QID Blood Glucose Testing System andare also compatible with the MediSense 2 Card and Pen Blood GlucoseTesting Systems. The Precision G Blood Glucose Test Strip is only foruse with the Precision G Blood Glucose Testing System. |
| Intended Use: | The Precision QID Blood Glucose Testing System is intended for invitro diagnostic use (i.e., for external use only) for the quantitativemeasurement of glucose in fresh capillary whole blood. For home orprofessional use with the Precision QID Blood Glucose Sensor.Compatible with the MediSense 2 Card and Pen Blood GlucoseSensors, and the Companion 2 Card and Pen Blood Glucose Sensors.The product may also be used by healthcare professionals for thequantitative measurement of glucose in venous, arterial, or neonatewhole blood, provided the sample is used within 30 minutes ofcollection.The Precision G Blood Glucose Testing System is intended for in vitrodiagnostic use (i.e., for external use only) for the quantitativemeasurement of glucose in fresh whole capillary blood. The PrecisionG Blood Glucose Testing System is intended for home or professionaluse. |
| Comparison toPredicate Device: | The proposed Precision QID and Precision G Blood Glucose Test Striphave technological characteristics equivalent to those of the predicatePrecision QID Blood Glucose Test Strip (K945887, K962295) andpredicate Precision G Blood Glucose Testing System (K963676). Theproposed Precision QID and Precision G Test Strip is comparable inform, function, material composition, manufacturing process, andintended use to the predicate Precision QID Test Strip and Precision GTest Strip. In addition the intended use for the proposed PrecisionQID and Precision G Test Strip is identical to the intended use ofanother predicate device, the Accu-Chek Advantage Test Strip(K951887, K954833). |
| PerformanceStudies: | The performance of the Precision QID and Precision G Test Strip wasstudied in the laboratory and in clinical settings by healthcareprofessionals and lay users. The studies demonstrated that user canobtain blood glucose results that are substantially equivalent to thecurrent methods for blood glucose measurement including the predicatedevices named above. |
| Conclusion: | Results of laboratory and clinical testing demonstrate that theperformance of the Precision QID and Precision G Blood Glucose TestStrip when used according to the intended use stated above isacceptable and comparable to the performance of the predicate devicesincluding 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
§ 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.