(140 days)
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No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML components or capabilities.
No.
The device is a glucometer used for monitoring blood glucose levels, which helps in managing diabetes, but it does not directly treat the condition.
Yes
The device is used for "self-monitoring of blood glucose as an adjunct to the care of persons with diabetes," which implies it provides information used to aid in the diagnosis, treatment, or prevention of disease. The "Summary of Performance Studies" also states that "users can obtain blood glucose results," which is a diagnostic output.
No
The device description explicitly lists hardware components: a blood glucose meter, test sensor disc, and controls.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "self-monitoring of blood glucose as an adjunct to the care of persons with diabetes." This involves testing a biological sample (blood) outside of the body to provide information for medical purposes (managing diabetes).
- Device Description: The system includes a "Blood Glucose Test Sensor Disc" and "Controls," which are components used to perform a test on a biological sample.
- Nature of the Test: Measuring blood glucose is a classic example of an in vitro diagnostic test. It analyzes a component of the blood to provide diagnostic or monitoring information.
The description clearly indicates that the device is used to perform a test on a biological sample (blood) outside of the body to provide information related to a medical condition (diabetes). This aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GLUCOMETER DEX Diabetes Care System is for the self-monitoring of blood glucose as an adjunct to the care of persons with diabetes.*
Product codes
75 CGA
Device Description
The GLUCOMETER DEX Diabetes Care System consists of the GLUCOMETER® DEX™ Blood Glucose Meter; GLUCOMETER® DEX™ Blood Glucose Test Sensor Disc; and the GLUCOMETER® DEX™ Controls (Normal, Low and High). The GLUCOMETER DEX Diabetes Care System is an over-the-counter (OTC) home test for glucose in blood. It is for use by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
persons with diabetes and by healthcare professionals in home settings and in healthcare facilities.
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
The performance of the GLUCOMETER DEX Diabetes Care System was studied in-house and in clinical settings by healthcare professionals and by persons with diabetes. The studies demonstrated that users can obtain blood glucose results that are substantially equivalent to current methods for blood glucose.
Key Metrics
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Predicate Device(s)
GLUCOMETER ELITE® Blood Glucose Monitoring System, YSI Model 2300 STAT Plus Analyzer, ACA® Discrete Clinical Analyzer, Hitachi 704 chemistry analyzer, Hitachi 747 chemistry analyzer
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
K9163500
JAN 2 | 1997
:
page 1 of 2
이 대한민국 대학교 대학교 대학교
510(k) SAFETY AND EFFECTIVENESS SUMMARY
| Prepared: | August 30, 1996 |
|---|---|
| Submitter: | Bayer Corporation, Business Group Diagnostics |
| Address: | 1884 Miles Avenue, P. O. Box 70 |
| Elkhart, IN 46515 | |
| (219) 262-6929 | |
| Contact: | Rosanne M. Savol, R.A.C. |
| Manager, Regulatory Affairs | |
| Device: | Trade/Proprietary Name: GLUCOMETER® DEX™ Diabetes Care System |
| Common/Usual Name: Test for glucose in blood | |
| Blood glucose meter | |
| Control material | |
| Document Control Number: K96 _______ | |
| Classification: | Division of Clinical Laboratory Devices |
| Panel - Clinical Chemistry and Toxicology | |
| Classification Code - 75 CGA (Glucose Oxidase, Glucose) | |
| Predicate Devices: | GLUCOMETER ELITE® Blood Glucose Monitoring System; |
| YSI Model 2300 STAT Plus Analyzer; ACA® Discrete Clinical | |
| Analyzer; Hitachi 704 chemistry analyzer; Hitachi 747 chemistry analyzer. | |
| Device Description: | The GLUCOMETER DEX Diabetes Care System consists of the |
| GLUCOMETER® DEX™ Blood Glucose Meter; | |
| GLUCOMETER® DEX™ Blood Glucose Test Sensor Disc; and | |
| the GLUCOMETER® DEX™ Controls (Normal, Low and High). | |
| The GLUCOMETER DEX Diabetes Care System is an over-the- | |
| counter (OTC) home test for glucose in blood. It is for use by | |
| persons with diabetes and by healthcare professionals in home | |
| settings and in healthcare facilities. |
1
Bayer Corporation, Business Group Diagnostics
GLUCOMETER® DEX™ Diabetes Care System S&E Summary page 2 of 2
:
이 대한민국 대학교 대학교
| Intended Use: | The GLUCOMETER DEX Diabetes Care System is for the self-
monitoring of blood glucose as an adjunct to the care of persons
with diabetes.* |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics: | The GLUCOMETER DEX Diabetes Care System employs an
amperometric glucose oxidase method to measure glucose in
blood. It is conceptually the same as other blood glucose
monitoring products available for blood glucose testing. The test
sensor discs are individually sealed in a package of ten. Blood
glucose results are referenced to plasma glucose. The System has
a linear response to glucose from 10 - 600 mg/dL. |
| Assessment of
Performance: | The performance of the GLUCOMETER DEX Diabetes Care
System was studied in-house and in clinical settings by healthcare
professionals and by persons with diabetes. The studies
demonstrated that users can obtain blood glucose results that are
substantially equivalent to current methods for blood glucose. |
| Conclusion: | The results of in-house and clinical evaluations of the
GLUCOMETER DEX Diabetes Care System demonstrate that
the device is equivalent in performance to the predicate devices
and suitable for its intended use. |
. ... ..............................................................................................................................................................................
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- "Consensus Statement on Self-Monitoring of Blood Glucose," Diabetes Care, Vol. 10, No. 1, January-February 1987, pp. 95-99.