(66 days)
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No
The description focuses on standard photometric and enzymatic principles for glucose measurement and does not mention any AI/ML components or related concepts like training/test sets.
No
The device is designed for testing glucose, which is a diagnostic function to monitor a condition, not to treat or alleviate a disease or condition directly.
Yes
Explanation: The device is described as "designed for testing glucose by persons with diabetes or by health care professionals". Testing glucose is a diagnostic function, as it provides information about a patient's health status (their blood glucose levels), which is used to diagnose, monitor, or manage a medical condition (diabetes).
No
The device description explicitly mentions an "Instrument Operating Principle -- photometric" and "Reagent Test Principle -- glucose deoxy reductase," indicating the use of hardware (photometer) and chemical reagents, which are not components of a software-only device.
Yes, the Glucotrend Basic System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "testing glucose by persons with diabetes or by health care professionals in the home or in health care facilities." This indicates it's used to examine specimens (blood in this case) taken from the human body to provide information for diagnostic purposes (managing diabetes).
- Device Description: The description mentions "Reagent Test Principle -- glucose deoxy reductase," which is a chemical reaction used to measure glucose in a sample. This is a hallmark of IVD devices.
- Performance Studies: The document details accuracy and precision studies performed using blood samples, which are typical evaluations for IVD devices that measure analytes in biological specimens.
Therefore, based on the provided information, the Glucotrend Basic System fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Glucotrend Basic System is designed for testing glucose by persons with diabetes or by health care professionals in the home or in health care facilities.
Product codes (comma separated list FDA assigned to the subject device)
LFR
Device Description
Instrument Operating Principle -- photometric
Reagent Test Principle -- glucose deoxy reductase
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 or by health care professionals in the home or in health care 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Accuracy:
Trained health care professional versus reference (Capillary blood): N = 202, y = 1.02x + 2.6, r = 0.989, range = 51 to 490 mg/dL
Trained health care professional versus reference (Venous blood): N = 104, y = 1.029 x + 2.7, r = 0.995, range = 35 to 483 mg/dL
Consumers versus reference: N = 134, y = 1.082x - 2.9, r = 0.976, range = 58 to 357 mg/dL
Precision:
N = 20/Level
Control Level 1: Mean = 84.0 mg/dL, SD = 2.0
Control Level 2: Mean = 196.4 mg/dL, SD = 2.5
Venous Blood Level 1: Mean = 28.7 mg/dL, SD = 1.2
Venous Blood Level 2: Mean = 87.3 mg/dL, SD = 2.6
Venous Blood Level 3: Mean = 129.4 mg/dL, SD = 3.0
Venous Blood Level 4: Mean = 229.2 mg/dL, SD = 2.8
Venous Blood Level 5: Mean = 335.0 mg/dL, SD = 3.4
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.
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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.
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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).
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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.
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OCT - 9 1997
Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
| 1) Submitter name, address, contact | Boehringer Mannheim Corporation
9115 Hague Rd.
Indianapolis, IN 46250
(317) 845-2000 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: Mike Flis |
| | Date Prepared: August 01, 1997 |
| 2) Device name | Proprietary name: Glucotrend TM Basic System |
| | Common name: self-monitoring blood glucose test system |
| | Classification name: Blood glucose test |
| 3) Predicate device | We claim substantial equivalence to the Boehringer Mannheim Accu-Chek Advantage System with the Advantage H Test Strip. |
Continued on next page
510(k) Summary
)
ﺴﺴﻪ
ﺗﻤﺴﻴﺴﺎ
్ర ప్రకారం
. . . . .
:
1
| 4) Device
Description | Instrument Operating Principle -- photometric
Reagent Test Principle -- glucose deoxy reductase | | |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| 5) Intended use | The Glucotrend Basic System is designed for testing glucose by persons with
diabetes or by health care professionals in the home or in health care facilities | | |
| 6) Comparison
to predicate
device | The Boehringer Mannheim Glucotrend Basic System is substantially
equivalent to other products in commercial distribution intended for similar
use. Most notably it is substantially equivalent to the currently marketed
Boehringer Mannheim Accu-Chek Advantage System with the Advantage H
Test Strip. | | |
| Similarities to
Predicate
Device | - Intended use (blood glucose monitoring) | | |
| | - Closed system (instrument and reagents are provided by BMC and are
intended to only be used in conjunction with each other) | | |
| | - Glucose dehydrogenase test principle | | |
| | - Verified reportable range (10 to 600 mg/dL) | | |
| | - Test strip packaging (desiccated vials with multiple strips) | | |
| | - Test strip storage conditions | | |
| | - Recommended quality control testing procedure | | |
| | - Specimen collection and preparation instructions | | |
| | - Monitor requires no scheduled maintenance other than cleaning | | |
| | - Instructions regarding response to unusual results | | |
| | - Warnings and precautions | | |
| | - Results referenced to whole blood laboratory testing | | |
Continued on next page
0 "G
2
Differences
ﻤﺴﺴﺴﺴﺴ
ﻣﺴﻠﺴﺔ
ﺘﺤﻘﻴﻘﺔ
| Feature | Accu-Chek Advantage
System with the
Advantage H Test
Strip (predicate) | Glucotrend Basic
(new device) |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Instrument operating
principle | amperometric | photometric |
| Blood sample types | capillary, venous,
arterial, and neonate | capillary and venous |
| Minimum sample
volume | 9 µL | 3 µL |
| Operating temperature
range | 14°C to 40°C | 10°C to 40°C |
| Hematocrit range | 20-65% at 200 mg/dL | 30-57% |
| Maximum altitude
verified | 10,150 feet | 9500 feet |
| Visual result back-up | None | Blank + 5 color blocks
on strip canister |
| Interferences | Low concentration:
· Xylose
High concentration:
• Uric Acid
· Galactose
· Lipemic sample >
5000 mg/dL | Low concentration:
· Xylose
High concentration:
• Uric Acid
· Galactose |
Continued on next page
3
Performance
. ﻣﻌﻬﺪ ﺍ
Characteristics
Accuracy
| Parameter | Accu-Chek Advantage
System with the
Advantage H Test
Strip (predicate) | Glucotrend Basic
(new device) |
|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Trained health care
professional versus
reference
(Capillary blood) | N = 166
y = 0.99x + 5.0
r = 0.973
range = 43 to 478 mg/dL | N = 202
y = 1.02x + 2.6
r = 0.989
range = 51 to 490 mg/dL |
| Trained health care
professional versus
reference
(Venous blood) | N = 166
y = 1.05X - 0.6
r = 0.990
range = 40 to 457 mg/dL | N = 104
y = 1.029 x + 2.7
r = 0.995
range = 35 to 483 mg/dL |
| Arterial blood study | N = 206
y = 1.06x - 3.5
r = 0.973 | not applicable |
| Neonate blood study | N = 303
y = 0.98x + 2.81
r = 0.94
range = 20 to 305 mg/dL
hematocrit range = 26 to
69% | not applicable |
| Consumers versus
reference | Not performed--claim
data from glucose oxidase
test strip supports OTC
use | N = 134
y = 1.082x - 2.9
r = 0.976
range = 58 to 357 mg/dL |
Continued on next page
4
Performance
Characteristics,
Contd.
ी में बाद में बाद में कि में कि में कि में कि कहानी के बाद में बाद में कि में बाद में कि में बाद में कि कहानी के बाद में बाद में कि किसी की कहानी के बाद में बाद में बाद में
Precision
| Parameter | Accu-Chek Advantage
System with the
Advantage H Test
Strip (predicate) | Glucotrend Basic
(new device) |
|---------------------------------------|---------------------------------------------------------------------------------|----------------------------------|
| | N = 96/Level (Control)
N = 60/Level (Blood) | N = 20/Level |
| Control Level 1
•Mean (mg/dL) | 42.0 | 84.0 |
| •Standard Deviation (SD) | 4.2 | 2.0 |
| Control Level 2
•Mean (mg/dL) | 104.0 | 196.4 |
| •Standard Deviation (SD) | 3.0 | 2.5 |
| Venous Blood Level 1
•Mean (mg/dL) | 53.0 | 28.7 |
| •Standard Deviation (SD) | 3.9 | 1.2 |
| Venous Blood Level 2
•Mean (mg/dL) | not applicable | 87.3 |
| •Standard Deviation (SD) | | 2.6 |
| Venous Blood Level 3
•Mean (mg/dL) | not applicable | 129.4 |
| •Standard Deviation (SD) | | 3.0 |
| Venous Blood Level 4
•Mean (mg/dL) | 233.0 | 229.2 |
| •Standard Deviation (SD) | 2.9 | 2.8 |
| Venous Blood Level 5
•Mean (mg/dL) | 490.0 | 335.0 |
| •Standard Deviation (SD) | 3.6 | 3.4 |
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The eagle is positioned in the center of a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircling it.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT - 9 1997
Mr. Mike Flis Boehringer Mannheim Corporation 9115 Haque Road Indianapolis, Indiana 46250
Re : K972876 Glucotrend™ Basic System Trade Name: Requlatory Class: II Product Code: LFR Dated: July 31, 1997 Received: August 4, 1997
Dear Mr. Flis:
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 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 regulations 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 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 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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Page 2
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 requlation 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 at (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
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
7
Indications for Use Statement
510(k) Number (if known): Device Name: Glucotrend Basic System
Indications for Use:
The Glucotrend Basic System is designed for testing glucose by persons with diabetes or by health care professionals in the home or in health care facilities.
(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 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboras vices
510(k) Number K972876
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