(75 days)
The Ferrara Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
The Ferrara Blood Glucose Monitoring System consists of a meter, test strips, and control solution. It is intended for over-the-counter, home use by diabetics to monitor their blood glucose levels, or for use in a clinical setting by health care professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument designed for use with Ferrara Blood Glucose Test Strips.
Here's an analysis of the acceptance criteria and the study conducted for the Ferrara Blood Glucose Monitoring System, based on the provided text:
Acceptance Criteria and Device Performance
The document does not explicitly state numerical acceptance criteria in a table format. Instead, it relies on a qualitative assessment of "good correlation" and "substantially equivalent" performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Good correlation between fingertip and alternate site results | Linear regression statistics, Clarke Error Grid Analysis, and Bias Analysis showed good correlation. |
| Substantial equivalence of palm alternate site to fingertip site | Testing demonstrated that the performance of Ferrara at the palm alternate site was substantially equivalent to that at fingertip. |
Study Information
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Sample Size used for the test set and data provenance:
- Sample Size: Not explicitly stated as a numerical value, but the study included "both men and women, with both Type 1 and Type 2 diabetes, ages from 20 to 83 years." The tested blood glucose values encompassed the "45-328 mg/dL glucose range."
- Data Provenance: The document does not specify the country of origin. It was a clinical study comparing "fingertip results obtained by clinicians with alternate site results (palm) results obtained by participants with diabetes," implying a prospective clinical trial design.
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Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- The document implies that "clinicians" obtained the fingertip results, which served as a reference point for comparison. However, the exact number of clinicians or their specific qualifications (e.g., years of experience, specialty) are not provided.
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Adjudication method for the test set:
- The document does not describe any specific adjudication method. The comparison was between clinician-obtained fingertip results and participant-obtained palm results.
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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 was not an MRMC comparative effectiveness study involving AI. It was a diagnostic device validation study comparing two different sample collection sites for a blood glucose monitor.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This was a standalone device performance study, in the sense that the device itself (Ferrara Blood Glucose Monitoring System) was being evaluated for its accuracy at different sites. There is no mention of a separate "algorithm" being tested independently from the device.
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The type of ground truth used:
- The "ground truth" for the alternate site measurements (palm) was the "fingertip results obtained by clinicians." This represents a reference method comparison, where one measurement (fingertip) is considered the accepted standard against which the new method (palm) is evaluated.
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The sample size for the training set:
- The document does not mention a separate "training set" or "training data" as this is not an AI/machine learning device. The study described is a clinical validation study.
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How the ground truth for the training set was established:
- See above, not applicable for this type of device and study.
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5 510(k) Summarv
| 5 510(k) Summary | DEC 2 0 2006 |
|---|---|
| Submitter: | Arkray USA |
| Contact Person: | Tom SpeikersDirector, Quality Systems and Regulatory AffairsArkray USA5182 W. 76th StreetMinneapolis, MN 55439Phone: 952-646-3168Fax: 952-646-3110speikerst@arkrayusa.com |
| Date Prepared: | October 3, 2006 |
| Trade Name: | Ferrara Blood Glucose Monitoring System |
| Classification: | Glucose test system, 21 CFR 862.1345; Class II |
| Product Codes: | CGA, NBW |
| Predicate Devices: | Advance Micro-draw BGM |
| Assure Pro BGM | |
| DeviceDescription: | The Ferrara Blood Glucose Monitoring System consists of ameter, test strips, and control solution. It is intended for over-the-counter, home use by diabetics to monitor their bloodglucose levels, or for use in a clinical setting by health careprofessionals. The system tests fresh capillary whole blood.The meter is a portable, battery-operated instrumentdesigned for use with Ferrara Blood Glucose Test Strips. |
| Intended Use: | The Ferrara Blood Glucose Monitoring System is intended forthe quantitative measurement of glucose in fresh capillarywhole blood samples drawn from the fingertips or palm.Testing is done outside the body ( In Vitro diagnostic use). Itis indicated for use at home (over the counter [OTC]) bypersons with diabetes, or in clinical settings by healthcareprofessionals, as an aid to monitor the effectiveness ofdiabetes control. |
| Functional andSafety Testing: | SUMMARY OF TECHNOLOGICAL CHARACTERISTICS |
| The Ferrara Blood Glucose Monitoring System is technicallyunchanged by this expansion of indications (claiming palm assample sites in addition to fingertip testing). The Ferrarasystem uses a meter substantially equivalent to the"Advance™ Micro-draw" meter with a test strip SE to theAssure Pro test strip. |
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1. NON-CLINICAL TESTING
Not Applicable
2. CLINICAL TESTING
Accuracy/method comparison testing was done comparing fingertip results obtained by clinicians with alternate site results (palm) results obtained by participants with diabetes.
Testing included both men and women, with both Type 1 and Type 2 diabetes, ages from 20 to 83 years. Tested blood glucose values encompassed the 45-328 mg/dL glucose range. Linear regression statistics, Clarke Error Grid Analysis, and Bias Analysis showed good correlation between fingertip and alternate site results.
- Testing demonstrated that the performance of Ferrara at the Conclusion: palm alternate site was substantially equivalent to that at fingertip.
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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 eagle with three stripes forming its wing and body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Tom Speikers Director, Quality Systems and Regulatory Affairs Arkrav USA 5182 W. 76th Street Minneapolis, MN 55439
DEC 2 0 2006
Re: K063068 Trade/Device Name: Ferrara Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: October 03, 2006 Received: October 06, 2006
Dear Mr. Speikers,
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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, M.D., M.
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
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Indications for Use Statement ব
510(k) Number (if known): K063068
Device Name: Ferrara Blood Glucose Monitoring System
Indications For Use:
Ferrara Blood Glucose Monitoring System:
The Ferrara Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Ferrara Blood Glucose Test Strips:
Ferrara Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or palm. Ferrara Test Strips must be used with the Ferrara Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control,
Ferrara Control Solution:
For use with Ferrara Blood Glucose Meter and Ferrara Test Strips as a quality control check to verify the accuracy of blood glucose test results.
Prescription Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ ×
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
CAC
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Office of In Vitro Diagnostic Device Evaluation and Safety
§ 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.