The Accurex Glucose Test Strip for use with the following glucometers: One Touchi Basic, OneTouch II and OneTouch Profile meters, all manufactured by Lifescan, Inc.

It is to be used for the quantitative measurement of glucose in fresh capillary whole blood. Glucose measurements are used as an aid to monitor the effectiveness of diabetes control.

Device Description

The Accurex Glucose Test Strip is a generic replacement for the Lifescan One Touch Glucose Test Strip. These glucose test strips can be used with the following glucometers: One Touch Profile, One Touch II, One Touch Basic (with large screen), One Touch Basic (with small screen).

AI/ML Overview

Here's an analysis of the provided text regarding the Accurex Glucose Test Strip, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed, standalone clinical trial report with specific acceptance criteria and detailed performance metrics as might be found in a more comprehensive study. Therefore, some of the requested information (especially about specific performance thresholds, full study design, and AI-related details) is not explicitly present in this type of regulatory submission.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (Accurex Glucose Test Strip)
Substantial Equivalence	Demonstrated to be substantially equivalent to the predicate One Touch Glucose Test Strip (K923544) manufactured by Lifescan Inc. This implies the device meets the safety and effectiveness standards of the predicate.
Indications for Use	Matches the predicate: Quantitative measurement of glucose in fresh capillary whole blood for use with One Touch, One Touch II, and One Touch Basic glucometers. Used as an aid to monitor the effectiveness of diabetes control.
Technological Characteristics	Found to have similar technological characteristics to the predicate device in areas such as indications for use, target population, where used, method comparison, and technical comparison. This suggests performance within acceptable ranges compared to the predicate, though specific numerical criteria are not detailed.

Study Details

Sample Size used for the test set and the data provenance:
- Test Set Sample Size: The document does not explicitly state the specific sample size used for the performance evaluation that demonstrated equivalence.
- Data Provenance: Not explicitly stated (e.g., country of origin). The document indicates performance comparison to a predicate device, which would typically involve testing of the new device. It is a regulatory submission for a medical device in the USA.
- Retrospective/Prospective: Not explicitly stated. For device validation, prospective testing is common, but the nature of this summary means such details are omitted.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. For a glucose test strip, the "ground truth" is typically established by comparative measurements against a laboratory reference method (e.g., a highly accurate glucose analyzer) rather than expert consensus on interpretation. The document mentions "method comparison" and "technical comparison," implying such a comparison was done.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation by radiologists). For objective quantitative measurements like glucose levels, comparison to a reference method is 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:
- This is not applicable. The Accurex Glucose Test Strip is a standalone in-vitro diagnostic device for measuring glucose levels. It does not involve human readers interpreting results in the way an imaging AI device would, nor does it involve AI assistance for human performance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, for this type of device, the performance evaluation would be a "standalone" assessment of the device's accuracy and precision compared to a reference method. The device itself (the test strip in conjunction with compatible glucometers) is the "algorithm only" in this context. The reported substantial equivalence is based on this standalone performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for a glucose test strip is typically established by comparing the device's readings to those obtained from a highly accurate laboratory reference method (e.g., a hexokinase method performed on a clinical chemistry analyzer). The summary mentions "method comparison," which supports this type of ground truth.
The sample size for the training set:
- Not applicable in the context of this device. Glucose test strips are primarily electrochemical or photometric devices; they do not typically undergo "training" like machine learning algorithms with a dedicated training set. Their performance is validated through analytical and clinical studies against known standards or reference methods.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the machine learning sense for this device.

Summary

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2006 MAR 9

K052207

Incline Medical, LLC

13560 SW Willow Top Lane Tigard, OR 97224 408-850-0198

SUMMARY

Submitter's name: Address:

Incline Medical, LLC 13560 SW Willow Top Lane Tigard, OR 97224 408-850-0198

Phone:

Name of contact person:

Greg Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 Fax: 949-552-2821

Date the summary was prepared: August 8, 2005

Trade Name:	Accurex Glucose Test Strip
Common/Usual Name:	Glucose Test System
Classification Name:	Glucose Oxidase, Glucose

The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]:

One Touch Glucose Test Strip, K923544 manufactured by Lifescan Inc.

Description of the device:

The Accurex Glucose Test Strip is a generic replacement for the Lifescan One Touch Glucose Test Strip. These glucose test strips can be used with the following glucometers:

One Touch Profile One Touch II One Touch Basic (with large screen) One Touch Basic (with small screen)

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Indications:

The Accurex Glucose Test Strip for use with the following glucometers: One Touch, One Touch II and One Touch Basic, all manufactured by Lifescan, Inc.

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 tumors.

Summary of the technological characteristics of our device compared to the predicate device:

The Accurex Glucose Test Strip were compared to the predicate in the following areas and found to have similar technological characteristics and to be equivalent.

Indications for use Target population Where used Method Comparison Technical Comparison

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine and health, with a circle of text surrounding it. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)". The logo is black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 9 2006

Incline Medical, LLC. c/o Mr. Greg Holland Regulatory Specialist Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine. CA 92606

K052207 Re:

Trade/Device Name: Accurex Glucose Test Strips Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA, NBW Dated: February 27, 2006 Received: February 28, 2006

Dear Mr. Holland:

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 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) 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 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with 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) 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 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,

Alberto Gutz

Alberto Gutierrez, Ph.D. 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): K052207

Device Name: Accurex Glucose Test Strips

Indications For Use:

The Accurex Glucose Test Strip for use with the following glucometers: One Touchi Basic, OneTouch II and OneTouch Profile meters, all manufactured by Lifescan, Inc.

It is to be used for the quantitative measurement of glucose in fresh capillary whole blood. Glucose measurements are used as an aid to monitor the effectiveness of diabetes control.

Prescription Use _ OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (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)

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Office of in Vitro Diagnostic Device Evaluation and Safety

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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.