(27 days)
Not Found
No
The summary describes a standard blood glucose meter and explicitly states that the modified device has the same technological characteristics as the predicate, with changes focused on ergonomics and integration with an insulin doser. There is no mention of AI, ML, or any related concepts.
No
The device is a blood glucose meter, which measures glucose levels, and is intended as an aid to monitor diabetes control, not to provide therapy.
Yes
The "Intended Use / Indications for Use" states that the device is for "quantitative measurement of glucose in fresh capillary whole blood" and is an "aid to monitor the effectiveness of diabetes control," which are diagnostic purposes. The text also explicitly states "in vitro diagnostic use."
No
The device is explicitly described as a "Blood Glucose Meter" and functions as a "cap for the InDuo™ Insulin Doser," indicating it is a physical hardware device.
Yes, the InDuo™ Blood Glucose Meter is an IVD (In Vitro Diagnostic) device.
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "The InDuo™ meter is intended for use outside the body ( in vitro diagnostic use)..."
- Measurement of Glucose in Blood: The device measures glucose in fresh capillary whole blood, which is a biological sample analyzed outside the body.
- Aid to Monitor Diabetes Control: The intended use is to aid in monitoring the effectiveness of diabetes control, which is a diagnostic purpose.
The "Device Description" also reinforces this by classifying it under 21 CFR § 862.1345, which is the regulation for Blood Glucose Test Systems.
N/A
Intended Use / Indications for Use
The InDuo™ Blood Glucose Meter is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The InDuo™ meter is intended for use outside the body (in vitro diagnostic use) by healthcare professionals and by diabetics at home as an aid to monitor the effectiveness of diabetes control.
The InDuo™ Blood Glucose Meter also functions as the cap for the InDuo™ Insulin Doser. The two devices fit together to form a single unit for user convenience.
Product codes
NBW, CGA, FMF
Device Description
Not Found
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
healthcare professionals and by diabetics at home
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)
Laboratory and clinical studies demonstrate that the InDuo™ Blood Glucose Meter provides equivalent performance to the ONE TOUCH® Ultra™ Blood Glucose Meter.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
JUN 2 1 2001
7.0 510(k) Summary
510(k) Summary
(As required by 21 C.F.R. § 807.92)
| Submitted By: | Inverness Medical Technology, Inc.
51 Sawyer Road
Suite 200
Waltham, MA 02453-3448
Phone: (781) 647-3900
Fax: (781) 647-3939 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Carol A. Adiletto, M.S.
Director of Clinical and Regulatory Affairs
Phone: (781) 314-4002
Fax: (781) 647-3939
e-mail: carol.adiletto@usa.invernessmedical.com |
| Date Summary Prepared: | May 24, 2001 |
| Device Name: | InDuo™ Blood Glucose Meter |
| Classification Name: | The InDuo™ Blood Glucose Meter is a Class II Device for home use, as per
21 CFR § 862.1345. |
| Substantial Equivalence: | The InDuo™ Blood Glucose Meter is substantially equivalent to the
previously cleared predicate device (K002134). |
| Description of Changes: | The changes made to the meter were done under design controls, and
include ergonomic changes to allow for inclusion of the InDuo™ Insulin
Doser to form a single unit for user convenience. |
| Statement of Intended Use: | The InDuo™ Blood Glucose Meter is intended to be used for the
quantitative measurement of glucose in fresh capillary whole blood. The
InDuo™ meter is intended for use outside the body ( in vitro diagnostic use)
by healthcare professionals and by diabetics at home as an aid to monitor
the effectiveness of diabetes control. |
| | The InDuo™ Blood Glucose Meter also functions as the cap for the InDuo™
Insulin Doser. The two devices fit together to form a single unit for user
convenience. |
| Technological
Characteristics: | The modified device has the same technological characteristics as the
legally marketed predicate. |
| Summary of Performance
Data: | Laboratory and clinical studies demonstrate that the InDuo™ Blood Glucose
Meter provides equivalent performance to the ONE TOUCH® Ultra™
Blood Glucose Meter. |
:
.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 1 2001
Ms. Carol A. Adiletto, M.S. Director of Clinical and Regulatory Affairs Inverness Medical Technology, Inc. 51 Sawyer Road - Suite 200 Waltham, MA 02453
510(k) Number: K011616 Re: Trade/Device Name: LifeScan InDuo™ Blood Glucose Meter Regulation Number: 862.1345, 880.5860 Regulatory Class: II Product Code: NBW, CGA, FMF Dated: May 24, 2001 Received: May 25, 2001
Dear Ms. Adiletto:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have love have determined the device is substantially equivalent 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 1 coord 1 ood, Drag, and sions of the Act. The general controls provisions of the Act include the general of 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 (1 remancer ripproval), in the Code of Federal Regulations, 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 periodio GMP insposited on one with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal addition, I Dri may packet 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 any obligation you imganian Control provisions, or other Federal laws or regulations.
2
Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to ocgin mansaling , quivalence of your device to a legally marketed notification. The FDA inding of succeantal requence and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and If you desire specific advice for your do to revices), please contact the Office of Compliance at additionally 609.10 for in True diagnestions on the promotion and advertising of your device, (201) 594-4588. Additionally, for questions of Compliance at (301) 594-4639. Also, please of Complex prease conact the Office or Compilance en premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionnes and use and more (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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
3
3.0 ODE Indications for Use Statement
Indications for Use Statement
LifeScan InDuo™ Blood Glucose Meter Device Name:
Indications for Use:
The InDuo™ Blood Glucose Meter is intended to be used for the quantitative The InDuo Blood Gracose Meter is intenate is blood. The InDuo" Blood Glucose measurent of gracose in noon capinary (in vitro diagnostic use) by healthcare Meter is intended for use outside the body (in This Chapter in and to monitor the effectiveness of diabetes control.
The InDuo™ Blood Glucose Meter also functions as the InDuo™ Insulin Doser.
The InDuo™ Blood Columnit Same as sensessiones The two devices fit together to form a single unit for user convenience.
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
10(k) Number K 011616
Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use