(74 days)
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No
The description focuses on a bar code reader for visually impaired users and does not mention AI or ML.
No
The device is designed for testing glucose levels and distinguishing insulin vials, which are diagnostic and assistive functions, not therapeutic. It does not treat or cure a disease.
Yes
The device is designed for testing glucose in whole blood, which is a diagnostic activity to help manage diabetes.
No
The device description explicitly states it is a "portable blood glucose test system" and incorporates hardware components like a monitor, test strips, lancet device, and a bar code reader.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's "Designed for testing glucose in whole blood". Testing substances in bodily fluids (like blood) to diagnose or monitor a medical condition (diabetes) is a core function of IVDs.
- Device Description: The description mentions it's a "portable blood glucose test system" and uses "Accu-Chek™ Comfort Curve™ Test Strips". Test strips used to analyze bodily fluids are a common component of IVDs.
- Predicate Device: The mention of a "Predicate Device(s)" which is a "Boehringer Mannheim Accu-Chek II Freedom" (another blood glucose monitor) further confirms its classification as an IVD, as predicate devices are used to demonstrate substantial equivalence for regulatory purposes for similar IVD devices.
While the device has an additional feature for visually impaired users (the bar code reader for insulin vials), its primary function of testing glucose in whole blood firmly places it in the category of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Designed for testing glucose in whole blood by visually impaired persons with diabetes.
Product codes (comma separated list FDA assigned to the subject device)
LFR
Device Description
The Accu-Chek Voicemate is a portable blood glucose test system. The Accu-Chek Voicemate incorporates proven technologies, such as the Accu-Chek® Advantage® Monitor, Accu-Chek™ Comfort Curve™ Test Strips, and Accu-Chek™ Softclix® Lancet Device.
The Accu-Chek Voicemate differs from the currently available devices in that it introduces a new function that will be especially helpful to the visually impaired insulin-using diabetics. We have worked in partnership with Eli Lilly & Company to develop a bar code reader that will reliably read bar codes printed on the insulin vials distributed by Eli Lilly. The bar code reader will help the visually impaired customers distinguish their insulin vials.
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
visually impaired persons with diabetes / over-the-counter
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.
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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.
0
| AUG 28 1998 | |
|---|---|
| 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 | Roche Diagnostics/Boehringer Mannheim Corporation |
| 9115 Hague Rd. | |
| Indianapolis, IN 46250 | |
| (800) 428-5074 |
Contact Person: Mike Flis
Date Prepared: June 12, 1998 |
| 2) Device name | Proprietary name: Accu-Chek Voicemate
Common name: self-monitoring blood glucose test system
Classification name: glucose test system |
| 3) Predicate
device | Boehringer Mannheim Accu-Chek II Freedom |
| 4) Device
Description | The Accu-Chek Voicemate is a portable blood glucose test system. The
Accu-Chek Voicemate incorporates proven technologies, such as the Accu-
Chek® Advantage® Monitor, Accu-Chek™ Comfort Curve™ Test Strips,
and Accu-Chek™ Softclix® Lancet Device.
The Accu-Chek Voicemate differs from the currently available devices in that
it introduces a new function that will be especially helpful to the visually
impaired insulin-using diabetics. We have worked in partnership with Eli
Lilly & Company to develop a bar code reader that will reliably read bar
codes printed on the insulin vials distributed by Eli Lilly. The bar code reader
will help the visually impaired customers distinguish their insulin vials. |
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Continued on next page
1
510(k) Summary, Continued
Designed for testing glucose in whole blood by visually impaired persons 5) Intended use with diabetes.
6) Comparison to predicate device
... ...
| Function | Accu-Chek Voicemate
(new device) | Accu-Chek II Freedom
(predicate device) |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use/Indications for
Use | Designed for testing glucose in whole
blood by visually impaired persons with
diabetes | Accu-Chek II Freedom Audio SBGM
System for the Visually Impaired is a
rechargeable, battery operated system for
visually impaired people with diabetes that
will accurately measure blood glucose levels |
| Incorporate which
Self-Monitoring
Blood Glucose
System | Accu-Chek Advantage Meter
Accu-Chek Comfort Curve Test Strips | Accu-Chek II Meter
Chemstrip bG Test Strips |
| Blood Collection
Device | None required. The test strips permit the
user to dose by applying a drop of blood to
the edge of the test strips. A "curve" is cut
into the test strip so that the exact location
of the dose is discernable through touch.
The patient may also touch the test strip
while dosing the test strip without
damaging the strips' reagent or
compromising the test result. | Accu-Drop™. The Chemstrip bG test strips
required the user to dose the test strips using
the Accu-Drop device (which guided the
blood sample to the test strips' reagent pad). |
| Preanalytic test strip
preparation | None required. Accu-Chek Comfort Curve
Test Strips do not require the user to time
any of the procedural steps, blot away
blood, or intervene in any manner once the
strip has been dosed. The test strip is
inserted into the meter before the blood
drop is applied. | The Chemstrip bG Test Strip required the
users to time the first step of the procedure,
wipe away excess blood from the strip and
then insert the test strip into the meter. |
| Insulin vial label
reader | Device is capable of reading bar codes
printed on specific insulin vial types. The
device's embedded software defines which
insulin vial labels may be read. | Function not available |
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white and appears to be a scanned image.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 28 1998
Mike Flis Regulatory Affairs Specialist Boehringer Mannheim 9115 Hague Road P.O. Box 50457 46250-0457 Indianapolis, Indiana
K982079 Re : Accu-Chek™ Voicemate™ System Regulatory Class: II Product Code: LFR Dated: June 12, 1998 Received: June 15, 1998
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, Druq, 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 aqainst 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. 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 regulation entifiled, "Misbranding by reference bo
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 Litman
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
4
510(k) Number (if known): Device Name: Accu-Chek™ Voicemate™ System Indications for Use:
Designed for testing glucose in whole blood by visually impaired persons with diabetes.
The product will be marketed over-the-counter.
(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 Devices 20 510(k) Number Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)