(583 days)
Not Found
None
No
The description details a chemical reaction on a test strip and a monitor measuring a color change, with no mention of AI or ML.
No
The device is for the quantitative determination of glucose in whole blood, which is a diagnostic function, not a therapeutic one. It measures a condition rather than treating or preventing it.
Yes
The device is described as performing "quantitative determination of glucose in whole blood," which is a measurement used to provide information for diagnosis or management of a disease (diabetes in this case).
No
The device description explicitly mentions a "Test Strip" and a "Monitor," which are hardware components used to measure blood glucose. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of glucose in whole blood." This means the device is used to test a sample taken from the body (blood) outside of the body (in vitro) to diagnose or monitor a medical condition (diabetes).
- Device Description: The description details how the test strip reacts with blood and how the monitor measures this reaction to provide a blood glucose value. This is a classic description of an in vitro diagnostic test.
The fact that it's used by professionals and people with diabetes further supports its classification as an IVD, as these are common users of diagnostic devices for managing health conditions.
N/A
Intended Use / Indications for Use
For use by professionals and people with diabetes for the quantitative determination of glucose in whole blood.
Product codes
CGA
Device Description
The Instant™ Test Strip, when used as directed with either the Accu-Chek® InstantPlus or Instant DM Monitor, will accurately measure the blood glucose value. The strip changes color as it reacts to glucose in a drop of blood, and the monitor measures this color change. The monitor displays the blood glucose result.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professionals and people with diabetes
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
K9444459
APR 1 7 1996
Attachment #5
Summary of Safety and Effectiveness
123
1
Summary of Safety and Effectiveness
(
!
ﮧ ﺳﮯ ﺗﺎ
| 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. | Boehringer Mannheim Corporation
9115 Hague Road
Indianapolis, Indiana 46250
Contact Person: Michael Flis
October 23, 1995 |
| 2. | Panel = Clinical Chemistry (75)
Classification No = CGA
Classification Name = Glucose Oxidase, Glucose
Regulation No = 21 CFR 862.1345
Classification = II |
| 3. | We claim equivalence to Boehringer Mannheim Corporation's Accu-Chek® Easy™ System. |
| 4. | The Instant™ Test Strip, when used as directed with either the Accu-Chek®
InstantPlus or Instant DM Monitor, will accurately measure the blood glucose value.
The strip changes color as it reacts to glucose in a drop of blood, and the monitor
measures this color change. The monitor displays the blood glucose result. |
| 5. | Intended Use: For use by professionals and people with diabetes for the quantitative
determination of glucose in whole blood. |
| 6. | As noted above in section 3, we claim equivalence to Boehringer Mannheim
Corporation's Accu-Chek® Easy™ System. |
:
124
2
SUMMARY OF SAFETY AND EFFECTIVENESS
ACCUTREND® GLUCOSE TEST
The Accutrend® Glucose Test is substantially equivalent to our Accu-Chek Easy Self Blood Glucose Monitoring System. Both systems are used to measure glucose in whole blood. The procedure for both tests entails applying a capillary blood sample to a dry chemistry test strip. Both test system utilize non-wipe technologies. The glucose oxidase reaction is measured in both tests. Both test systems have lot-specific coding for each lot of test strips. Finally, both the Accutrend GC and Accu-Chek Easy systems are blood glucose monitoring devices which have been cleared specially for home use.
Boehringer Mannheim Corporation 9115 Hague Road Indianapolis, Indiana 46256
Image /page/2/Picture/4 description: The image shows a distorted and unclear view of some handwritten text. The text appears to be written in cursive, but the letters are not easily discernible due to the image's poor quality and heavy distortion. The writing is slanted and appears to be on a white background.