(81 days)
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No
The summary describes a standard glucose meter and test strips, with no mention of AI/ML terms, image processing, or data sets typically associated with AI/ML development.
No.
The device is used for testing glucose levels, which is a diagnostic function, not a therapeutic intervention. It measures a condition but does not treat or alleviate it.
Yes
The device is intended for testing glucose, which is a diagnostic measurement for persons with diabetes.
No
The device description explicitly states it is an "Accu-Chek Complete Meter," which is a physical device designed for measuring glucose. It also mentions the use of "Accu-Chek Advantage or Accu-Chek Advantage H Test Strips," which are hardware components. This indicates it is a hardware-based medical device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "testing glucose... in the home or in health care facilities." This is a diagnostic test performed outside of the body.
- Device Description: The device description clearly states it's an "invitro device designed for measuring the concentrations of glucose in whole blood." "In vitro" means "in glass" or "outside of the body," which is the core characteristic of an IVD.
- Anatomical Site: The anatomical site is "whole blood," which is a biological sample tested outside of the body.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Accu-Chek Complete System is intended 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, CGA
Device Description
The Accu-Chek Complete Meter is an invitro device designed for measuring the concentrations of glucose in whole blood which is applied to Accu-Chek Advantage or Accu-Chek Advantage H Test Strips. The Accu-Chek Complete System is designed for testing glucose by persons with diabetes or by health care professionals in the home or in health care 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 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)
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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.
K930979, #K951887, and #K954833
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.
0
K973662
Dec. 15, 1997
510(k) Summary
| 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: |
| 2) Device name | Proprietary name: Accu-Chek Complete Meter
Common name: Blood glucose test system
Classification name: glucose dehydrogenase, glucose |
| 3) Predicate device | We claim substantial equivalence to the Boehringer Mannheim Accu-Chek Advantage System. 510(k) files #K930979, #K951887, and #K954833. |
| 4) Device Description | The Accu-Chek Complete Meter is an invitro device designed for measuring the concentrations of glucose in whole blood which is applied to Accu-Chek Advantage or Accu-Chek Advantage H Test Strips. |
| | Continued on next page |
1
510(k) Summary, Continued
The Accu-Chek Complete System is designed for testing glucose by persons 5) Intended use with diabetes or by health care professionals in the home or in health care facilities. The Boehringer Mannheim Accu-Chek Complete System is substantially 6) Comparison equivalent to other products in commercial distribution intended for similar to predicate use. Most notably it is substantially equivalent to the currently marketed device Accu-Chek Advantage System.
Continued on next page
2
510(k) Summary, Continued
(
(
| Similarities to
Predicate
Device | Intended use [testing glucose in whole blood by persons with diabetes or
by health care professionals in the home or health care facilities]
Indicated for over-the-counter use with capillary blood samples only
[Accu-Chek Advantage and Accu-Chek Advantage H Test Strips]
Indicated for use with capillary, venous, arterial, and neonate blood
samples by professionals (only applies to use with Accu-Chek H Test
Strips) -- professional use with Accu-Chek Advantage Test Strips is
limited to capillary blood samples
Glucose dehydrogenase or glucose oxidase test strip (test principle) is
unchanged - meter will operate with either strip version
Meter operating procedure unchanged [The Advantage Test Strip
employs the electrochemical principle of biamperometry. The monitor
applies a voltage between two identical electrodes, the causes the
reduced mediator formed during the test's incubation period to be
reconverted to oxidized mediator. This generates a small current that is
read by the meter.]
Meter coding procedure unchanged
Test strip dosing location remains outside the monitor -- meaning no
strip guide or monitor optics cleaning required. Meter cleaning [Damp
cloth of 10% bleach solution] and troubleshooting procedures
unchanged.
Meter storage condition limits unchanged [-13°F to 149°F,