The Accu-Chek Inform Meter is designed to quantitatively measure the concentration of glucose in whole blood samples. The device is indicated for use by health care professionals and persons with diabetes mellitus.

The Accu-Chek Inform Meter is an addition to the Accu-Chek brand of blood glucose monitors that incorporates the fundamental scientific technology currently found in the Accu-Chek Advantage Meter and Accu-Chek Complete Meter. The Accu-Chek Inform Meter is designed for use in conjunction with either the Accu-Chek Advantage or Accu-Chek Comfort Curve test strips.

Device Description

The Accu-Chek Inform system is addition to the Accu-Chek brand of blood glucose monitors that incorporates the fundamental scientific technology currently found in the Accu-Chek Advantage Meter. The Accu-Chek Inform Meter is a modification to the Accu-Chek Advantage Meter that involves integrating the AccuData GTS unit's data gathering features into the meter. The modification does not affect the device's intended use. The Accu-Chek Inform Meter may be used in conjunction with the same test strips indicated for use with the Accu-Chek Advantage Meter, and the test principle described on the following page is not affected by the design modifications. This modification can be accomplished due in part to the availability of palmtype computers (PDA). Our product designers modified the Accu-Chek Advantage Meter by building into its body an off-the-shelf PDA. The PDA module enabled our designers to integrate the AccuData GTS unit's data gathering features into the meter itself. The Accu-Chek Inform Meter was designed to be convenient and easy to use.

AI/ML Overview

The provided text describes a Special 510(k) submission for the Accu-Chek™ Inform® Meter, which is a modification of an existing device (Accu-Chek Advantage Meter). Therefore, the study presented focuses on demonstrating substantial equivalence to the predicate device, rather than establishing de novo performance criteria for the modified device.

As a result, the document does not contain information on discrete acceptance criteria and a detailed study explicitly proving the device meets those criteria in the way a new device would. Instead, it asserts that the modifications to the Accu-Chek Advantage Meter, primarily involving integrating data gathering features into the meter, do not affect the fundamental scientific technology, intended use, indications for use, or analytical performance claims.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document as distinct, quantifiable acceptance criteria with corresponding performance results. The submission relies on the assertion that "Meter model does not significantly affect analytical performance claims" and "Meter model does not significantly affect method comparison results" as compared to the predicate device.

2. Sample size used for the test set and the data provenance

This information is not provided. The document states that analytical performance and performance comparisons are "Derived from testing with the two test strips listed above. Claims are stated in test strip package inserts." This implies that the performance data originates from studies conducted on the test strips themselves, which are compatible with both the predicate and the modified device, rather than a specific new study for the Accu-Chek Inform Meter. No details on the sample size or provenance for this underlying test strip data are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. As the submission focuses on substantial equivalence based on the predicate device's established performance with associated test strips, there's no mention of a new test set requiring expert ground truth establishment for the modified meter itself.

4. Adjudication method for the test set

This information is not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided. The device is a blood glucose meter, not an AI-assisted diagnostic imaging or analysis tool that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not directly applicable or provided in the context of an algorithm-only performance study. The device is a meter that measures glucose concentration; its "performance" is inherently tied to its ability to accurately measure blood glucose. The submission states the meter's software converts electrical signals to glucose values, and that "Meter model does not significantly affect analytical performance claims." This implies the "standalone" performance of the measurement system (meter + test strip) is considered equivalent to the predicate.

7. The type of ground truth used

The type of ground truth for blood glucose measurements is generally established through comparison to a laboratory reference method. The document states, "The system's correlation to a comparative laboratory method is established by the manufacturer." However, specific details about the nature of this "comparative laboratory method" are not provided in this summary.

8. The sample size for the training set

This information is not provided. There is no mention of a "training set" in the context of this device, as it's a quantitative measurement device rather than a machine learning model that would typically require a training set.

9. How the ground truth for the training set was established

This information is not provided and is not applicable for the reasons mentioned above.

In summary, this 510(k) submission leverages the established performance of its predicate device and compatible test strips. It explicitly states that the modifications (integration of data management features) do not alter the fundamental scientific technology, intended use, or analytical performance. Therefore, detailed new studies with specific acceptance criteria and performance data for the modified device are not presented because the argument for substantial equivalence rests on the lack of impact of the modifications on these critical performance aspects.

Summary

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K012210

AUG - 9 2001

Special 510(k) Summary
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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 Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 845-2000Contact Person: Mike Flis
	Date Prepared: July 13, 2001
2) Device name	Proprietary name: Accu-Chek™ Inform ® MeterCommon name: whole blood glucose test systemClassification name: Glucose dehydrogenase, glucose
3) Predicate device	We claim substantial equivalence to the Roche Diagnostics Accu-Chek Advantage Meter.

Continued on next page:

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Special 510(k) Summary, Continued

The Accu-Chek Inform system is addition to the Accu-Chek brand of blood 4) Device glucose monitors that incorporates the fundamental scientific technology Description currently found in the Accu-Chek Advantage Meter. The Accu-Chek Inform Meter is a modification to the Accu-Chek Advantage Meter that involves integrating the AccuData GTS unit's data gathering features into the meter. The modification does not affect the device's intended use. The Accu-Chek Inform Meter may be used in conjunction with the same test strips indicated for use with the Accu-Chek Advantage Meter, and the test principle described on the following page is not affected by the design modifications. This modification can be accomplished due in part to the availability of palmtype computers (PDA). Our product designers modified the Accu-Chek Advantage Meter by building into its body an off-the-shelf PDA. The PDA module enabled our designers to integrate the AccuData GTS unit's data gathering features into the meter itself. The Accu-Chek Inform Meter was designed to be convenient and easy to use. The Accu-Chek Inform Meter is designed to quantitatively measure the 5) Intended use

concentration of glucose in whole blood samples. The device is indicated for use by health care professionals and persons with diabetes mellitus.

Continued on next page

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Special 510(k) Summary, Continued

Comparison to predicate device

The Roche Diagnostics Accu-Chek Inform Meter is substantially equivalent to the Accu-Chek Advantage Meter, as the following table shows.

	Accu-Chek Advantage Meter(predicate device)	Accu-ChekInform Meter
Intended use	The meter is designed to quantitatively measure theconcentration of glucose in a whole blood sample.	No change
Indications for use	The device is indicated for professional use and over-the-counter sale.	No change
Fundamentalscientifictechnology	The measurement is accomplished by applying a controlledvoltage between two identical electrodes embedded withinthe test strip, which causes the reduced mediator formedduring the glucose dehydrogenase reaction to be reconvertedto an oxidized mediator. This generates a small current thatis measured by the meter. The meter's software converts thiselectrical currency signal into a blood glucose value. Thesystem's correlation to a comparative laboratory method isestablished by the manufacturer; each test strip vial ispackaged with a calibration code key that the user insets intothe meter to ensure an appropriate calibration.	No change
OTC User'sManual	Professional and lay person instructions included within onemanual.	Professional and layperson instructionsprovided in separatemanuals.
Analyticalperformanceclaims	Derived from testing with the two test strips listed above.Claims are stated in test strip package inserts. Meter modeldoes not significantly affect analytical performance claims.	No change
Performancecomparisons	Derived from testing with the two test strips listed above.Claims are stated in test strip package inserts. Meter modeldoes not significantly affect method comparison results.	No change
Data management	Home use – blood glucose and liquid control testing resultsHealth care provider (w/AccuData GTS) -- blood glucose,liquid control, linearity, and proficiency testing results andoperator and patient identification	No change
Technical Service	Accu-Chek Customer Care Center available to respond tocustomer questions via a toll-free telephone service around-the-clock, every day of the year.	No change

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes, suggesting movement or flight. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG - 9 2001

Mr. Mike Flis Regulatory Affairs Principal Roche Diagnostics Corporation 9115 Hague Road PO Box 50457 Indianapolis, IN 46250-0457

510(k) Number: K012210 Re: Trade/Device Name: Accu-Chek™ Inform® Meter Regulation Number: 862.1345 Regulatory Class: II. Product Code: NBW, LFR Dated: July 13, 2001 Received: July 16, 2001

Dear Mr. Flis:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your wined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mersate conmisers price to hat 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 I cacal I ood, Drag, and Goomist be Act. The general controls provisions of the Act include the general of the is provention, 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 ( remainer ripps of a love found in the Code of Federal Regulations, Title 21, Parts 800 to 895. arroomig your as not con can t determination assumes compliance with the Good Manufacturing 11 Substantally Vequiral (GMP) regulation (21 CFR Part 820) and that, through r ractions, GMP inspections, the Food and Drug Administration (FDA) will verify such perfoure offic inspections of the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal addition, Please note: this response to your premarket notification submission does not affect register. Freason you might have under sections 531 through 542 of the Act for devices under the any obligation you anglation Control provisions, or other Federal laws or regulations.

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Page 2 -

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 entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/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

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Indications for Use Statement

Special 510(k) Number (if known): Kolaa10 Device Name: Accu-Chek™ Inform® Meter

Indications for Use:

(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
510(k) Number K012210
Cooper

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.