(119 days)
The FreeStyle 600 Blood Glucose Monitoring System is intended for in vitro diagnostic use for the quantitative measurement of glucose in fresh capillary, venous, arterial and neonatal whole blood samples. The FreeStyle 600 Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use). The FreeStyle 600 Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels.
The FreeStyle Blood Glucose Monitoring System comprises an electrochemical biosensor glucose reagent test strip, a handheld meter, a quality control solution, a complete Owner's Booklet and a Quick Reference Guide. A lancing device, lancets and a logbook for recording test results are also included with the system.
When the user inserts a test strip, the meter turns on. The user acquires a blood sample (with the test strip in the meter) by picking up the meter and touching the edge of the test strip at the blood target area, filling the chamber on the strip by capillary action. The meter sounds a tone (beeps) to let the user know that the sample chamber is full and the reaction has begun. When the test is complete, the meter displays the glucose reading on its liquid crystal display (LCD).
Here's an analysis of the provided text regarding the FreeStyle 600 Blood Glucose Monitoring System, detailing the acceptance criteria and study information:
Acceptance Criteria and Device Performance Study
The provided 510(k) summary for the FreeStyle 600 Blood Glucose Monitoring System outlines its performance studies and a general conclusion of acceptability and comparability to a comparative method. However, specific quantitative acceptance criteria (e.g., accuracy percentages, precision metrics) and detailed reported performance metrics are not explicitly stated in the summary. The summary focuses more on the type of studies conducted and the conclusion of substantial equivalence rather than granular performance data against predefined thresholds.
1. Table of Acceptance Criteria and Reported Device Performance
Since specific numerical acceptance criteria were not found in the provided text, the table below reflects what was implied and the general conclusion provided.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device performance | Demonstrated substantial equivalence |
| Acceptable performance for intended use | Performance acceptable and comparable to a comparative method |
| Healthcare professionals could obtain substantially equivalent results | Demonstrated healthcare professionals could obtain substantially equivalent results |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The summary mentions "Performance Studies" conducted in "the laboratory and in clinical settings."
- Data Provenance: The studies were conducted in "the laboratory and in clinical settings by healthcare professionals." The country of origin is not specified, but the submission is to the U.S. FDA, implying the studies were likely conducted in the U.S. or followed U.S. regulatory guidelines. The summary does not specify whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated. The studies were conducted "by healthcare professionals," implying multiple individuals were involved in the clinical settings, but the exact number or their specific roles in establishing ground truth (e.g., as a reference method operator) are not detailed.
- Qualifications of Experts: Not explicitly stated. They are referred to as "healthcare professionals."
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. The summary mentions results being "substantially equivalent to a comparative method," but the process by which "ground truth" was established or adjudicated is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: Not applicable/not mentioned. This device is a blood glucose monitoring system, not an imaging or diagnostic AI system that typically involves multiple human readers interpreting results. The study design described is focused on the device's accuracy against a recognized reference method.
6. Standalone (Algorithm Only) Performance
- Standalone Performance: The study inherently reflects standalone performance of the device system. The FreeStyle 600 Blood Glucose Monitoring System operates by taking a blood sample and displaying a glucose reading. The "performance studies" would evaluate the accuracy of this system (meter + strips) against a reference method. There is no separate "human-in-the-loop" component in the direct operation of this type of device that would differentiate between an algorithm-only performance and an assisted performance.
7. Type of Ground Truth Used
- Ground Truth Type: A "comparative method" was used. For blood glucose monitoring systems, this typically refers to a highly accurate laboratory reference method for measuring blood glucose, such as a YSI glucose analyzer. The summary states that the device's performance was "substantially equivalent to a comparative method."
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/not mentioned. The provided summary is for a traditional medical device (blood glucose meter) which does not typically involve machine learning or AI models with distinct "training sets" in the conventional sense. The device's calibration and algorithm are established during its development and manufacturing, not through a separate "training set" of patient data as seen in AI/ML products.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As explained above, for this type of device, there isn't a "training set" with established ground truth in the same way as an AI/ML model. The device's accuracy is validated against reference methods during its development and performance studies.
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JUN 27 2005
510(k) SUMMARY
.
This summary of 510(k) Safety and Effectiveness information is being submitted in This sunning of I 10(x) Satsy and Enectrical so the Manch 2008 and 2008 and 2008 and 2008
accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k
| Date Prepared: | February 23, 2005 |
|---|---|
| Submitted by: | Kimberley KlineSenior Regulatory Associate |
| TheraSense, Inc.1360 South Loop RoadAlameda, CA 94502 | |
| Phone: (510) 749-5478Fax: (510) 239-2799 | |
| Device Name: | FreeStyle 600 Blood Glucose Monitoring System |
| Common Name: | Blood Glucose Meter and Reagent Test Strips |
| Classification: | Glucose Test SystemClass II per 21 CFR 862.1345 |
| Predicate Devices: | FreeStyle Blood Glucose Monitoring System, K992684, K000582,K012014, K031260Precision PCx 2.2.1 Blood Glucose System, K022941 |
| Description: | The FreeStyle Blood Glucose Monitoring System comprises anelectrochemical biosensor glucose reagent test strip, a handheldmeter, a quality control solution, a complete Owner's Booklet and aQuick Reference Guide. A lancing device, lancets and a logbook forrecording test results are also included with the system.When the user inserts a test strip, the meter turns on. The useracquires a blood sample (with the test strip in the meter) by pickingup the meter and touching the edge of the test strip at the blood targetarea, filling the chamber on the strip by capillary action. The metersounds a tone (beeps) to let the user know that the sample chamber isfull and the reaction has begun. When the test is complete, the meterdisplays the glucose reading on its liquid crystal display (LCD). |
| Intended Use: | The FreeStyle 600 Blood Glucose Monitoring System is intended forin vitro diagnostic use for the quantitative measurement of glucose infresh capillary, venous, arterial and neonatal whole blood samples.The FreeStyle 600 Blood Glucose Monitoring System is for testingoutside the body (in vitro diagnostic use). The FreeStyle 600 BloodGlucose Monitoring System is intended for use in the home and inprofessional settings to monitor blood glucose levels. |
| Principle ofOperation: | The user obtains a blood sample using a conventional lancingtechnique on the finger, forearm, upper arm, hand, thigh, calf, orpalm. The user inserts a test strip into the meter, which turns themeter on. When the strip is touched to the blood drop, the samplechamber on the strip fills by capillary action in approximately 2seconds. The blood sample volume required is approximately 0.3microliters (300 nanoliters), which can be obtained from the finger,forearm, upper arm, hand, thigh, calf, or palm. Test results aredisplayed in about 15 seconds. The time required to display testresults varies depending on the blood glucose concentration(approximately 15 to 45 seconds). |
| The glucose in the blood sample reacts with the glucosedehydrogenase enzyme to yield gluconolactone, and produces a smallelectrical current. This current is measured by the FreeStyle meterand displayed as a glucose level. | |
| Comparison toPredicate Device: | The FreeStyle 600 Blood Glucose Monitoring System has the sametechnological characteristics as the predicate device, FreeStyle™Blood Glucose Monitoring System, K992684, K000582, K012014,K031260 and the same intended use as the Precision PCx 2.2.1 BloodGlucose System, K022941. |
| PerformanceStudies: | The performances of the FreeStyle 600 Blood Glucose MonitoringSystem was studied in the laboratory and in clinical settings byhealthcare professionals. The studies demonstrated that healthcareprofessionals could obtain blood glucose results that are substantiallyequivalent to a comparative method. |
| Conclusion: | Results of laboratory and clinical testing demonstrates that theperformance of the FreeStyle 600 Blood Glucose Monitoring Systemwhen used according to the intended use stated above is acceptableand comparable to the performance to a comparative method.Clinical test results support a determination of substantialequivalence. |
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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 features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
2008 JUL 3
Abbott Diabetes Care, Inc. c/o Ms. Marv Edwards Interim Vice-President Regulatory Affairs 1320 South Loop Road Alameda, CA 94502
Re: K050500
Trade/Device Name: FreeStyle 600 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, LFR, JJX Dated: May 24, 2005 Received: May 25, 2005
Dear Ms. Edwards:
This letter corrects our substantially equivalent letter of June 27, 2005.
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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to continue 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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Device Evaluation and Safety at (240) 276-0652 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Jean M. Cooper, M.S., R.V.M.
Jean M. Cooper, M.S., 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
K050500 510(k) Number (if known):
Device Name: FreeStyle 600 Blood Glucose Monitoring System
Indications For Use:
The FreeStyle 600 Blood Glucose Monitoring System is intended for in vitro diagnostic use for the quantitative measurement of glucose in fresh capillary, venous, arterial and neonatal whole blood samples. The FreeStyle 600 Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use). The FreeStyle 600 Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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510(k) Kososoro
§ 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.