The Accu-Chek Integra system is designed to quantitatively measure the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals for monitoring glucose in the home or in health care facilities. The device is indicated for professional use and over-the-counter sale. Professionals may use the test strips to test capillary and venous blood samples; lay use is limited to capillary whole blood testing. Capillary blood samples can be acquired from fingertips, forearm, upper arm, thigh, calf and palm.

Device Description

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Accu-Chek Integra System, based on the provided text:

Acceptance Criteria and Device Performance

The provided text states that "All predetermined acceptance criteria were satisfied" and that the "clinical data demonstrates that the performance of the Accu-Chek Integra correlates well with the laboratory plasma glucose reference test method." However, specific numerical acceptance criteria were not detailed in the provided document. The document primarily focuses on similarities to a predicate device and general performance claims rather than specific quantitative thresholds for accuracy or precision.

The only quantitative performance mentioned that resembles an "acceptance criteria" is for Quality Control (QC) materials:

Feature/Claim	Acceptance Criteria (from QC)	Reported Device Performance
Quality control acceptable range	The mean is strip lot specific and will be determined individually. The range of the controls is within ± 15 mg/dL or ± 15% compared to the determined mean.	Not explicitly stated for overall device performance, but the study "demonstrated that the device meets the performance requirements for its intended use" and "correlates well with the laboratory plasma glucose reference test method."

Study Information

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document only mentions "A multi-center performance study was conducted."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The ground truth is referred to as "the laboratory plasma glucose reference test method," implying a standardized lab method, but details on who performed or verified this ground truth for the test set are not provided.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. This type of adjudication is typically for image-based diagnostic studies and is not directly relevant to a glucose meter study. The reference method itself acts as the gold standard.
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:
- No. This is a glucose meter, not an AI-assisted diagnostic imaging device, so an MRMC study is not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The "Accu-Chek Integra System" performance was evaluated against a reference method. The device itself performs the measurement, and the study assesses this direct measurement capability.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- "Laboratory plasma glucose reference test method." This indicates a standard, probably highly accurate, clinical laboratory method for measuring glucose.
The sample size for the training set:
- Not applicable as this is not an AI/machine learning device that requires a training set in that sense. The device's calibration and performance are based on its hardware and chemical reagents.
How the ground truth for the training set was established:
- Not applicable for the same reason as point 7.

Summary

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MAY - 2 2005 510(k) Summary ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------According to the requirements of 21 CFR 807.92, the following information Introduction According to the requirements in the basis for a determination of substantial equivalence. Roche Diagnostics 1) Submitter 9115 Hague Rd. name, Indianapolis, IN 46250 address, contact (317) 521-7688 Contact Person: Dimitris Demirtzoglou Date Prepared: April 1, 2005 and the same of the same of the same of the same of the same of the same of the same of the same and the seat and the seat and the seat and the seat of the seat of the seat o Proprietary name: Accu-Chek Integra System 2) Device Classification name: Glucose dehydrogenase, glucose test system name (21 C.F.R. § 862.1345)(75LFR) We claim substantial equivalence to the current legally marketed Accu-3) Predicate Chek Compact System (K#031755). device ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Instrument Operating Principle -- photometry 4) Device Reagent Test Principle -- glucose dehydrogenase Description and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the contribution of th The Accu-Chek Integra system is designed to quantitatively measure the 5) Intended THC Accu 'Onck intogra oyets... illary whole blood by persons with diabetes use concentration of grassessionals for monitoring glucose in the home or in or by nounth ours proves is indicated for professional use and over-the-counter sale. Professionals may use the test strips to test capillary and venous blood Professionals may aso the toot epillary whole blood testing. Capillary blood samples, luy doe is immed to off may .
samples can be acquired from fingertips, forearm, upper arm, thigh, calf and palm.

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K 650877

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510(k) Summary, Continued

The Roche Diagnostics Accu-Chek Integra System is substantially 6) Similarities The Hoone Diagnoction Alegally marketed Accu-Chek Compact (predicate) System. The proposed modification is relatively modest in scope. The Oyoton: The proposes of the claims and features unaffected by the proposed modification.

Feature/Claim	Detail
Intended use	The Accu-Chek Integra and Accu-Chek Compact systems aredesigned to quantitatively measure the concentration of glucose incapillary whole blood for monitoring glucose. The devices areindicated for professional use and over-the-counter sale. Professionalsmay use the test strips to test capillary and venous blood samples; layuse is limited to capillary whole blood testing. Both systems areindicated for Alternate Site Testing use.
Test principle	Glucose dye oxidoreductase mediator reaction.
Test strip storageconditions	Store at room temperature between +36° F (+2° C) and +86° F (+30° C).
Test strip operatingconditions	Between +5° F (+10° C) and +104° F (+40° C).
Quality controltesting frequency	Tests should be run with liquid quality control materials whenever a new vialof test strips is opened or an unusual blood test result is obtained.
Quality controlacceptable range	The mean is strip lot specific and will be determined individually. The rangeof the controls is within ± 15 mg/dL or ± 15% compared to the determinedmean.
Labeling instructionsregarding expectedresults	The normal fasting adult blood glucose range for a non-diabetic is 65-95mg/dL (related to whole blood) mg/dL. One to two hours after meals,normal blood glucose levels should be less than 140 mg/dL. Doctors willdetermine the range that is appropriate for the patients.
Labeling instructionsregarding responseto unusual results	Run a quality control test, if the result is outside the acceptable QC recoveryrange contact Roche Diagnostics's Accu-Chek Customer Care center; ifresult is within the acceptable range, review proper testing procedure andrepeat blood glucose test with a new test strip.

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510(k) Summary, Continued

6) Similarities (continued)

Feature/Claim	Detail
Acceptable sample types	Capillary whole blood samples from a fingerstick or AST site. Venous blood may also be used only if drawn by health care professionals.
Reportable range	10-600 mg/dL
Hematocrit range	25 - 65%
Warnings and precautions	For in vitro diagnostic use only.

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510(k) Summary, Continued

Data demonstrating substantial equivalence

Performance testing on the modified Accu-Chek Integra System demonstrated that the device meets the performance requirements for its intended use. A multi-center performance study was conducted to evaluate the accuracy and precision of the modified device. The clinical data demonstrates that the performance of the Accu-Chek Integra correlates well with the laboratory plasma glucose reference test method. All predetermined acceptance criteria were satisfied. The data also demonstrates that the Accu-Chek Integra is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY - 2 2005

Mr. Dimitris Demirtzoglou Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road PO Box 50416 Indianapolis, IN 46250

K050872 Re:

Trade/Device Name: Accu-Chek Integra Test System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: LFR, NBW Dated: April 4, 2005 Received: April 6, 2005

Dear Mr. Demirtzoglou:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the Merce, 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) that do not require approval of a premarket approval application (PMA). 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 general obliable profice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device n may be oubject to data about Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be actious that I Driving that your device complies with other requirements of the Act that I Drivias Intact and regulations administered by other Federal agencies. You must or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) rmarket 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html

Sincerely yours,

Sean M. Cooper, MS, DVM

Jean M. Cooper, MS. D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Accu-Chek Integra Test System

Indications For Use:

Professionals may use the test strips to test capillary and venous blood samples; lay use is I rotestinate illary whole blood testing. Capillary blood samples can be acquired from fingertips, forearm, upper arm, thigh, calf and palm.

Prescription Use X (Part 21 CFR 801 Subpart D) (AND/OR

Over-The-Counter Use __X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and

510(k) K050872

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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.