(109 days)
The FREEDOM Blood Glucose Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. The FREEDOM Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm, palm, thigh and calf.
The FREEDOM Blood Glucose Monitoring System is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the FREEDOM Test Strips.
The test principle is:
This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.
This is an in vitro diagnostic device, not an AI/ML device, so many of the requested categories (e.g., number of experts, adjudication method, MRMC study, sample size for training set) are not applicable. The information provided focuses on the device's accuracy against established references, which is typical for this type of device.
Acceptance Criteria and Device Performance
The provided 510(k) summary does not explicitly state acceptance criteria in a quantitative table format nor reported device performance in a similar table. However, based on the nature of blood glucose monitoring systems and the reference to substantial equivalence to predicate devices, the acceptance criteria would implicitly involve the device demonstrating accuracy and precision comparable to or better than the predicate devices and meeting relevant ISO standards for blood glucose monitoring.
From the information provided, it states that the device measures "the concentration of glucose in whole blood" and is "an aid in monitoring the effectiveness of diabetes management." The device claims "substantial equivalence to the LifeScan, Inc., OneTouch® Ultra®" and others. This implies that the performance (accuracy, precision) of the FREEDOM Blood Glucose Monitoring System must be within acceptable limits relative to these established predicate devices.
Implicit Acceptance Criteria (based on common standards for IVD blood glucose meters) & Reported Device Performance:
| Acceptance Criteria (Inferred from industry standards for IVD Blood Glucose Meters) | Reported Device Performance (Inferred from "substantial equivalence") |
|---|---|
| Accuracy: Results within a certain percentage/absolute difference of reference (e.g., < 15% difference for glucose > 75 mg/dL, < 15 mg/dL difference for glucose < 75 mg/dL on at least 95% of readings, as per ISO 15197) | Implied to meet or exceed the performance of predicate devices (e.g., LifeScan OneTouch® Ultra®) |
| Precision: Low variability (standard deviation or coefficient of variation) across repeated measurements. | Implied to meet or exceed the precision of predicate devices. |
| Measurement Range: Capable of accurately measuring across a clinically relevant glucose range. | Implied to match or exceed the range of predicate devices. |
| Interfering Substances: Demonstrate minimal interference from common substances that might affect glucose readings. | Implied to have comparable resistance to interference as predicate devices. |
Note: The 510(k) summary itself does not contain a detailed performance study report with specific accuracy or precision statistics for the FREEDOM Blood Glucose Monitoring System. The claim of "substantial equivalence" is the primary basis for market clearance, implying that the detailed performance data submitted to the FDA (but not included in this summary) demonstrated comparable performance to the predicate devices.
Study Details
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Sample size used for the test set and the data provenance:
The provided summary does not include specific details about the sample size used for performance testing or the provenance of the data (e.g., country of origin, retrospective/prospective). For an in vitro diagnostic device like a blood glucose meter, the test set would typically involve human blood samples across a range of glucose concentrations, tested against a reference method. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable for a blood glucose monitoring system. The "ground truth" for blood glucose measurements is established by a highly accurate and precise laboratory reference method (e.g., an enzymatic hexokinase method on a laboratory analyzer), not by human expert opinion. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable. Adjudication methods involving multiple human readers are used for subjective interpretations (e.g., image analysis, clinical diagnoses). For quantitative measurements like blood glucose, the reference method provides a definitive quantitative value, not a subjective interpretation requiring adjudication. -
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. An MRMC study is relevant for AI/ML devices that assist human readers in tasks like image interpretation. This device is a standalone in vitro diagnostic system for measuring a biochemical analyte. It does not involve human readers or AI assistance in interpretation. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, this is implicitly a standalone performance study. The FREEDOM Blood Glucose Monitoring System is an "algorithm only" type of device in the sense that it performs a chemical and electrical measurement and provides a numerical output without human interpretation being part of its diagnostic function. Its performance is evaluated on its ability to accurately and precisely provide glucose concentrations compared to a reference standard. The product description emphasizes the electrochemical signal and its measurement by the meter, displayed as a blood glucose result. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth would be established by a highly accurate and precise laboratory-based reference method for glucose measurement, such as a hexokinase enzymatic method or isotope dilution-mass spectrometry (IDMS), performed on a clinical laboratory analyzer. -
The sample size for the training set:
This is not applicable in the context of traditional in vitro diagnostic devices like blood glucose meters. There is no "training set" in the machine learning sense. The device's electrochemical principles and algorithms are fixed during design and manufacturing. Performance is validated through testing on clinical samples, not by iterative training. -
How the ground truth for the training set was established:
As there is no training set in the AI/ML sense, this question is not applicable. The device's operating principles and internal calibration are established during its engineering design, and its accuracy is validated against a definitive laboratory reference standard.
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American HealthCare, Inc. 510(k) for In Vitro Diagnostic Device
510(k) SUMMARY
(As required by 21.CFR.807.92)
| Introduction: | According to the requirements of 21 CFR.807.92, the followinginformation provides sufficient data to understand the basis for adetermination of substantial equivalence. |
|---|---|
| Submitted By: | American HealthCare, Inc.304 Park Avenue SouthSuite 218New York, NY 10010 |
| Contact Person: | Edward LetkoPhone: 917-402-5900Fax: 212-202-5173 |
| Date Summary,Prepared: | December 14, 2004 |
| Device Name: | Propriety Name: FREEDOM Blood Glucose Monitoring SystemCommon Name: Blood Glucose Test SystemClassification Name: Class II, 862.1345 Glucose Blood Tester |
| Predicate Device: | We claim substantial equivalence to the LifeScan, Inc.,OneTouch® Ultra®. |
| DeviceDescription: | The FREEDOM Blood Glucose Monitoring System is an in vitrodiagnostic device designed for measuring the concentration of glucose inwhole blood, which is used with the FREEDOM Test Strips.The test principle is:This device is an in vitro diagnostic product intended for themeasurement of glucose concentration in human blood. The principle ofthe test relies upon a specific type of glucose in the blood sample, thedehydrogenase glucose that reacts to electrodes in the test strip. The teststrip employs an electrochemical signal generating an electrical currentthat will stimulate a chemical reaction. This reaction is measured by theMeter and displayed as your blood glucose result. |
| Intended Use: | The FREEDOM Blood Glucose Monitoring System, is used for thequantitative measurement of glucose in whole blood as an aid inmonitoring the effectiveness of diabetes management in the home and inclinical settings. The FREEDOM Blood Glucose Monitoring System isfor |
| testing outside the body (in vitro diagnostic use only). Testing siteinclude the traditional fingertip testing along with alternate sitetesting on the arm, palm, thigh and calf. | |
| Comparison to | |
| Predicate Device: | The US Diagnostics, Inc. FREEDOM Blood Glucose MonitoringSystem is substantially equivalent to the other products incommercial distribution intended for similar use. The mostnotable, it is substantially equivalent to the currently marketeditem, the OneTouch® Ultra® by LifeScan, Inc. |
| Conclusion: | The FREEDOM Blood Glucose Monitoring System issubstantially equivalent to the following predicate devices:K024194 - LifeScan, Inc. OneTouch® Ultra®K984261 - LifeScan, Inc. SURESTEP®K021513 - Roche Diagnostics Corp. Accu-Chek Advantage |
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American HealthCare, Inc.
.
:
510(k) for In Vitro Diagnostic Device
510(k) Summary, Continued
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APR 8 2005 Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Edward Letko Managing Director American HealthCare Inc. 304 Park Avenue South Suite 218 New York, NY 10010
Re: K043543
Trade/Device Name: FREEDOM Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: March 2, 2005 Received: March 2, 2005
Dear Mr. Letko
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 (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,
Jean 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: K043543
Device Name: FREEDOM Blood Glucose Monitoring System
Indications For Use: The FREDOM Blood Glucose Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. The FREEDOM Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm, palm, thigh and calf.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 807 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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Carol Benem
Division Sign-Off
Office of in vitro Diagnostic Device Evaluation and Safety
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§ 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.