(70 days)
Not Found
Not Found
No
The description focuses on reflectance photometry and minimizing optical/chemical interferences, which are traditional analytical techniques, and there is no mention of AI or ML terms or concepts.
No
The device is a monitoring system that measures blood glucose levels, which is used as an adjunct to the care of persons with diabetes, not a therapeutic device that treats the condition.
Yes
The device is used to measure glucose in blood, which is a key indicator for diagnosing and monitoring diabetes. The "Intended Use / Indications for Use" section explicitly states it's for "frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes," indicating its role in managing a medical condition.
No
The device description explicitly states it is a "reflectance photometer" and is used with "Blood Glucose Test Strips," indicating it is a hardware device that measures glucose.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "home test for glucose in blood" and is used to "monitor blood glucose." This involves testing a biological sample (blood) outside of the body to gain information about a person's health status (glucose levels related to diabetes).
- Device Description: The description details how the system "determine[s] the glucose concentration in whole blood" using a reflectance photometer and test strips. This is a classic description of an in vitro diagnostic process.
- Specimen Types: The system is designed for use with "capillary and venous blood specimens, arterial blood specimens and neonatal blood specimens," all of which are biological samples tested in vitro.
The core function of the device is to analyze a biological sample (blood) outside of the body to provide diagnostic information (glucose levels). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GLUCOMETER ENCORE QA+ Blood Glucose Monitoring System is an over-the-counter (OTC) home test for glucose in blood. The system is for use by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes. The GLUCOMETER ENCORE QA+ Blood Glucose Monitoring System can be used with capillary and venous blood specimens, arterial blood specimens and neonatal blood specimens.
Product codes (comma separated list FDA assigned to the subject device)
75 CFR
Device Description
The GLUCOMETER ENCORE QA+ Blood Glucose Meter is part of the GLUCOMETER ENCORE Blood Glucose Monitoring System. The GLUCOMETER ENCORE Blood Glucose Monitoring System is an over-the-counter home testing system for measuring glucose in blood. The System is for use by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities. The GLUCOMETER ENCORE QA+ Blood Glucose Meter is a reflectance photometer used with GLUCOMETER ENCORE® Blood Glucose Test Strips to determine the glucose concentration in whole blood. The modified instrument minimizes the optical and chemical interferences of hemoglobin with the test strips.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home settings and in healthcare facilities; by persons with diabetes and by healthcare 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the GLUCOMETER ENCORE QA+ Blood Glucose Meter (Neonatal Modification) was evaluated in studies inhouse and in healthcare facilities with neonatal blood specimens. The results of the studies demonstrated good performance in comparison to clinical laboratory blood glucose analyzers.
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.
GLUCOMETER ENCORE® Blood Glucose Monitoring System, ACCU-CHEK® ADVANTAGE® Blood Glucose System (Boehringer Mannheim Corporation), YSI Blood Glucose Analyzer (Yellow Springs Instrument Company, Inc.)
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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JUN 1 6 1997
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15971276
510(k) SAFETY AND EFFECTIVENESS SUMMARY
| Prepared: | April 3, 1997 |
|---|---|
| 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 ENCORE® QA+ Blood Glucose Meter (Neonatal Modification) |
| Common/Usual Name: Test for glucose in blood | |
| Document Control Number: K97 ________ | |
| Classification: | Division of Clinical Laboratory Devices |
| Panel - Clinical Chemistry and Toxicology | |
| Classification Code - 75 CFR (Hexokinase, Glucose) | |
| Predicate Devices: | GLUCOMETER ENCORE® Blood Glucose Monitoring System |
| ACCU-CHEK® ADVANTAGE® Blood Glucose System (Boehringer Mannheim Corporation) | |
| YSI Blood Glucose Analyzer (Yellow Springs Instrument Company, Inc.) | |
| Device Description: | The GLUCOMETER ENCORE QA+ Blood Glucose Meter is part of the GLUCOMETER ENCORE Blood Glucose Monitoring System. The GLUCOMETER ENCORE Blood Glucose Monitoring System is an over-the-counter home testing system for measuring glucose in blood. The System is for use by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities. |
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Bayer Corporation, Business Group Diagnostics GLUCOMETER ENCORE® QA+ Blood Glucose Meter S&E Summary page 2 of 2
GLUCOMETER ENCORE OA+ Blood Glucose Meter is for the Self-Intended Use: Monitoring of Blood Glucose as an adjunct to the care of persons with diabetes The GLUCOMETER ENCORE QA+ Blood Glucose Meter (Neonatal Modification) can be used to measure glucose in capillary and venous blood specimens, arterial specimens and neonatal specimens. Technological The GLUCOMETER ENCORE QA+ Blood Glucose Meter is a Characteristics: reflectance photometer used with GLUCOMETER ENCORE® Blood Glucose Test Strips to determine the glucose concentration in whole blood. The modified instrument minimizes the optical and chemical interferences of hemoglobin with the test strips. Accurate results can be obtained at hematocrit levels and glucose levels that are seen in neonatal populations. Assessment of The performance of the GLUCOMETER ENCORE QA+ Blood Performance: Glucose Meter (Neonatal Modification) was evaluated in studies inhouse and in healthcare facilities with neonatal blood specimens. The
The results of the clinical evaluation of the GLUCOMETER ENCORE Conclusion: QA+ Blood Glucose Meter (Neonatal Modification) on neonatal blood specimens demonstrated that the device is equivalent in performance to the predicate devices and suitable for use with neonatal blood specimens.
clinical laboratory blood glucose analyzers.
results of the studies demonstrated good performance in comparison to
- "Consensus Statement on Self-Monitoring of Blood Glucose," Diabetes Care, Vol. 10, No. 1, January-February 1987, pp. 95-99.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 16 1997
Rosanne M. Savol, R.A.C. Manager, Regulatory Affairs Bayer Corporation 1884 Miles Avenue P.O. Box 70 46514-0070 Elkhart, Indiana
发
Re: K971276 GLUCOMETER ENCORE® QA+Blood Glucose Meter(Modified) Requlatory Class: II CFR Product Code: Dated: April 3, 1997 Received: April 7, 1997
Dear Ms. Savol:
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 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with . the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (CHA-60), Chils device may require if it does, you should contact Caccgorization: io ase 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 described in your sial equivalence of your device to a legally rinding of bubbeanded on concention in a classification for your marketed predicate acits your device to proceed to the market.
ત્ત્વ 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/dsmamain.html".
Sincerely yours,
Steven Ditman
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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510(k) Number (if known):
GLUCOMETER ENCORE® QA+ Blood Glucose Monitoring Device Name: System
The GLUCOMETER ENCORE QA+ Blood Glucose Monitoring Indications for Use: System is an over-the-counter (OTC) home test for glucose in blood. The system is for use by persons with diabetes and by healthcare professionals in home settings and in healthcare વ્યું facilities. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes. The GLUCOMETER ENCORE QA+ Blood Glucose Monitoring System can be used with capillary and venous blood specimens, arterial blood specimens and neonatal blood specimens.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory evices
510(k) Number K97127
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)