(205 days)
The Precision Xtra / MediSense Optium / Precision Easy / MediSense Optium Easy Blood Glucose Test Strip is intended for outside-of-the-body (in-vitro diagnostic) use. The system is indicated for the quantitative measurement of glucose in fresh whole blood for self-testing by lay users (e.g., from the finger, forearm, upper arm or base of thumb), or by health care professionals. The test strip is to be used for monitoring blood glucose concentrations in persons with diabetes and other conditions.
The test strip is for blood glucose testing utilizes amperometric biosensor technology to generate a current. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measure of glucose in whole blood and control solutions.
Acceptance Criteria and Study for Precision Xtra/MediSense Optium Blood Glucose Test Strip
The provided document describes the 510(k) premarket notification for the Precision Xtra/MediSense Optium Blood Glucose Test Strip. The acceptance criteria for this device are implicitly tied to demonstrating "substantial equivalence" to a predicate device, the Precision Xtra® Blood Glucose Testing System (K010553). The performance studies conducted aimed to show that the new test strip yields blood glucose results "substantially equivalent" to current methods, including the predicate device, for both laboratory and clinical settings, and that trained operators and lay users obtain equivalent results.
While specific numerical acceptance criteria are not explicitly stated in a table within the provided text, the core acceptance criterion is that the device's performance is acceptable and comparable to the predicate device and current methods for blood glucose measurement. This includes achieving substantially equivalent results when testing blood glucose concentrations during a steady state, and also when comparing fingertip results to alternative sites (forearm, upper arm, or base of thumb).
1. Table of Acceptance Criteria and Reported Device Performance
As specific numerical acceptance criteria were not explicitly quantified in the provided text, the table below reflects the qualitative acceptance criteria implied by the substantial equivalence claim and the reported performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantially equivalent to predicate device (K010553) | Performance is acceptable and comparable to the predicate device. |
| Substantially equivalent to current methods for blood glucose measurements | Lay users can obtain blood glucose results substantially equivalent to current methods. |
| Equivalent results between trained operators and lay users | Clinical performance testing demonstrates trained operators and lay users obtain equivalent whole blood glucose results. |
| Equivalent results when testing at alternative sites (forearm, upper arm, base of thumb) compared to fingertip | Results of laboratory and clinical testing demonstrated acceptable performance, including alternative sites. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific sample size used for the test set in either the laboratory or clinical studies. It mentions that the performance was studied "in the laboratory and in clinical settings."
- Data Provenance: The document does not specify the country of origin of the data. The studies were conducted in "laboratory and clinical settings" and involved "healthcare professionals and lay users," suggesting real-world testing. The study is prospective in nature, as it involves testing the new device to demonstrate its performance.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not specified.
- Qualifications of Experts: The clinical studies involved "healthcare professionals," but their specific qualifications (e.g., years of experience, specialty) are not detailed.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (such as 2+1, 3+1, or none) for establishing ground truth for the test set. Given the nature of blood glucose measurement, the "ground truth" would typically be established by a reference laboratory method or the predicate device itself, rather than expert consensus on interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is present. This is not applicable as the device is a blood glucose test strip, not an AI-powered diagnostic imaging tool.
6. Standalone (Algorithm Only) Performance Study
The device itself is a test strip, not an algorithm in the traditional sense of AI. Therefore, a "standalone algorithm only" performance study is not applicable. The performance is inherently tied to the chemical reactions on the strip and the accompanying meter. The studies evaluated the performance of the "test strip, when used according to the intended use stated above," which implies the entire system (strip + meter).
7. Type of Ground Truth Used
The type of ground truth used is implied to be reference laboratory methods for blood glucose measurement and comparison to the predicate device (Precision Xtra® Blood Glucose Testing System, K010553). The goal was to show "substantial equivalence" to these established methods and devices.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning, as this device is a chemical biosensor, not an AI algorithm requiring a training phase.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of an AI algorithm.
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APR 2 3 2003
Precision Xtra/MediSense Optium Blood Glucose Test Strip
510(K) SUMMARY As Required By 21 CFR 807.92
| Submitted by: | Janet Connolly, RACSr. Regulatory Affairs SpecialistAbbott Laboratories, MediSense Products4A Crosby DriveBedford, MA 01730-6230 |
|---|---|
| Device Name: | Precision Xtra / MediSense Optium / Precision Easy / MediSenseOptium Easy Blood Glucose Test Strip with True Measure Technology |
| Common Name: | Self-Monitoring Blood Glucose System |
| Classification: | Glucose Test SystemClass II per 21 CFR 862.1345 |
| Predicate Device: | Precision Xtra® Blood Glucose Testing System, K010553 |
| Description: | The test strip is for blood glucose testing utilizes amperometricbiosensor technology to generate a current. The size of the current isproportional to the amount of glucose present in the sample, providinga quantitative measure of glucose in whole blood and control solutions. |
| Intended Use: | The test strip is intended for outside-the-body ( in-vitro diagnostic) use.The system is indicated for the quantitative measurement of glucose infresh whole blood for self-testing by lay users (e.g., from the finger,forearm, upper arm or base of thumb), or by health care professionals.The test strip is to be used for monitoring blood glucose concentrationsin persons with diabetes and other conditions. |
| Comparison toPredicate Device: | The test strip has equivalent technological characteristics as thePrecision Xtra Blood Glucose Test Strip (K010553). The test strip hasthe same intended use as the original test strip with the addition offorearm, upper arm and base of thumb. |
| PerformanceStudies: | The performance of the test strip was studied in the laboratory and inclinical settings by healthcare professionals and lay users. The studiesdemonstrated that lay users can obtain blood glucose results that aresubstantially equivalent to the current methods for blood glucosemeasurements, which include the predicate device listed above. Theperformance studies also demonstrate that testing blood glucoseconcentrations, during a steady state, are substantially equivalent. |
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between the fingertip and alternative sites (i.e. forearm, upper arm or base of thumb).
Conclusion: Results of laboratory and clinical testing demonstrate that the performance of the test strip, when used according to the intended use stated above, is acceptable and comparable to the performance of the previously mentioned predicate device for blood glucose testing. In addition, results of clinical performance testing demonstrate that trained operators and lay users obtain equivalent whole blood glucose results.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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APR 2 3 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Janet Connolly, RAC Senior Regulatory Submissions Specialist Abbott Laboratories MediSense Products 4A Crosby Drive Bedford, MA 01730
Re: K023256
Trade/Device Name: Preision® Xtra® /MediSense® Optium™ Blood Glucose Test Strip with True Measure Technology Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, LFR Dated: January 23, 2003 Received: January 24, 2003
Dear Ms. Connolly:
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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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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE FORM
Ko23356 510(k) Number (if known):
Precision® Xtra® / MediSense® Optium™ Blood Glucose Test Strip Device Name: with True Measure Technology
Precision® Easy / MediSense® Optium™ Easy Blood Glucose Test Strip with True Measure Technology
Indications For Use:
The Precision Xtra / MediSense Optium / Precision Easy / MediSense Optium Easy Blood Glucose Test Strip is intended for outside-the-body (in-vitro diagnostic) use. The system is indicated for the quantitative measurement of glucose in fresh whole blood for self-testing by lay users (e.g., from the finger, forearm, upper arm or base of thumb), or by health care professionals. The test strip is to be used for monitoring blood glucose concentrations in persons with diabetes and other conditions.
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.108) Over-The-Counter Use
. .
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K023256
or
§ 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.