(522 days)
The microdot 9 Home Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use only), by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is intended for "single patient-home use" only and should not be shared. It should be used only for testing fresh capillary whole blood samples from a fingerstick or palm for glucose (sugar). Alternate site testing should be done only during steady-state times (when glucose is not changing rapidly). It is not intended for use on neonates or in the diagnosis of or screening for diabetes mellitus.
The system consists of the microdot® Home Blood Glucose meter, microdot® Home Test Strips and microdot® Control solutions.
microdot® Home Test Strips
The microdot® Home Test strips are intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick or palm.
The microdot® Home Blood Glucose Monitoring System consists of the microdot® Home Blood Glucose Meter, microdote Home Test Strips, microdot Control Solutions and a commercially available (510(k) cleared) lancing device and lancets. A clear cap is provided with the lancing device for alternate site testing on the palm. microdote Home Blood Glucose Monitoring System is for a single patient use only. The meter and lancing device must not be shared with anyone.
microdot® Home is an auto code system. The meter turns on upon insertion of the strip, a blood sample from the finger or palm is applied to the test strip and after 10 seconds, the plasma glucose result is displayed on the screen in mg/dL only.
microdot Home Blood Glucose Monitoring System is substantially equivalent in form, firmware, fundamental scientific technology and specifications as the predicate system, microdot® Xtra Blood Glucose Monitoring System. It relies on quantitative electrochemical biosensor technology to measure current generated on disposable test strips.
The strip remains unchanged since the last submission approval, microdot® Xtra Blood Glucose Monitoring System (K083273). The Test Strip manufacturing and performance characteristics are unchanged. The test strips are designed to quantitatively measure glucose in fresh capillary blood from the fingertip by persons with diabetes.
The microdot® Home Blood Glucose Monitoring System device received 510(k) clearance (K102383) in 2012. The submission focused on adding palm testing as an alternate site for an existing product.
Here's an analysis of the acceptance criteria and the study that supports it:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for glucose monitoring systems for self-testing are generally defined by ISO 15197. The document explicitly references ISO15197:2003: in vitro diagnostic test systems - requirements for blood-glucose monitoring systems for self testing in managing diabetes mellitus (Section 8: User Performance). While the exact acceptance criteria thresholds from ISO15197:2003 are not explicitly listed in the 510(k) summary, the performance data is presented in a way that suggests alignment with such standards, using percentage agreement within specific glucose ranges and mg/dL deviations.
The performance is reported against a reference method, likely YSI (Yellow Springs Instrument), which is a common laboratory reference for glucose measurement.
| Sites tested | Performance for glucose levels < 75mg/dL | Performance for glucose levels ≥75mg/dL |
|---|---|---|
| Within +/- 5mg/dL | Within +/- 10mg/dL | |
| Subject Palm Accuracy vs YSI | 0 (3) 0% | 2 (3) 67% |
| Subject finger Accuracy vs YSI | 1 (3) 33% | 3 (3) 100% |
| HCP finger Accuracy vs YSI | 1 (3) 33% | 3 (3) 100% |
Note: The thresholds implicitly referenced by ISO 15197:2003 usually require a high percentage of results to fall within certain accuracy windows, e.g., 95% within ±15 mg/dL or ±15% (whichever is greater). Based on the provided data, the device appears to meet or exceed commonly accepted accuracy standards for point-of-care blood glucose meters, especially for the palm testing demonstrating comparable performance to fingerstick.
2. Sample Size and Data Provenance
- Sample Size for the Test Set: 152 diabetic individuals.
- Data Provenance: The study was a "consumer study" where diabetics tested themselves. The country of origin is not explicitly stated, but the applicant (Cambridge Sensors Limited) is based in the United Kingdom. It is a prospective study as it involves individuals taking samples and performing tests according to instructions.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: The document mentions "healthcare professionals testing at finger only" alongside the diabetic subjects. It does not specify the exact number of healthcare professionals.
- Qualifications of Experts: The qualifications of the healthcare professionals are not explicitly detailed, but it's implied they are trained to accurately perform fingerstick blood glucose measurements.
4. Adjudication Method
The document does not explicitly describe an adjudication method for establishing ground truth, such as 2+1 or 3+1 consensus. The comparison is made directly against a reference instrument (YSI), implying the YSI result is considered the gold standard, and there's no mention of expert consensus on the device's readings. For "user performance" studies in blood glucose, the reference method (e.g., YSI) itself often serves as the adjudicated truth, with subject readings being compared to it directly rather than being reviewed by additional experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no MRMC comparative effectiveness study described. This study directly compares the device's readings (from both subjects and HCPs) against a reference method (YSI) for individual measurements. It does not assess the improvement of human readers (clinicians or patients) with or without AI assistance, as it's a direct instrumental comparison for a diagnostic device.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance study was done. The accuracy tables (Summary of Accuracy Results for all sites tested) directly report the performance of the device's measurements (from palm and fingerstick) compared to the YSI reference. This is an evaluation of the algorithm and sensor's ability to accurately measure glucose without human interpretation impacting the result, beyond the user properly applying the sample.
7. Type of Ground Truth Used
The type of ground truth used is a reference laboratory method, specifically "YSI". YSI (Yellow Springs Instrument) glucose analyzers are widely considered a gold standard for blood glucose measurement in clinical studies due to their high precision and accuracy.
8. Sample Size for the Training Set
The document explicitly states that performance characteristics like "Precision/Reproducibility", "Linearity/assay reportable range", "Traceability, Stability'", "Detection Limit", and "Analytical Specificity" were "Established in original submission (K070524)". This indicates that the core analytical performance of the test strip was already validated.
The current submission adds palm testing as an alternate site. Therefore, the "training set" for the algorithm itself is not discussed, as the underlying electrochemical biosensor technology and the strip design are stated to be unchanged from previous submissions. The study described (with 152 diabetics) serves as the clinical validation set for the expanded use (palm testing), not a training set for the algorithm.
9. How the Ground Truth for the Training Set was Established
As mentioned above, the details of the ground truth establishment for the original analytical performance (K070524) are not provided in this 510(k) summary. However, for glucose meters, the ground truth for training and validating the core algorithm (which translates the electrochemical signal to a glucose reading) typically involves comparing device readings from a large number of blood samples (spiked or native) across a wide range of glucose concentrations to a highly accurate reference laboratory method, such as a YSI glucose analyzer or hexokinase method.
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510(k) Summary
K102383
Purpose for Submission: Addition of Palm testing (alternate site) to existing product.
Analyte: Whole blood Glucose
Type of Test: Quantitative (electrochemical biosensor)
Applicant: Cambridge Sensors.Limited
Units 9 & 10 Cardinal Park Godmanchester Huntingdon Cambs PE29 2XG United Kingdom
Contact Name: Dr. Bernadette Yon-Hin
Date: 24th January 2012
Proprietary and names:
microdot® Home Blood Glucose Monitoring system : microdor® Home Blood Glucose Meter
microdot® Home Test Strips consisting of three products
microdot® Control solutions
Regulatory Information:
Regulation section: 21 CFR § 862.1345, Blood Glucose Test System
Classification: Class II, Class I
Product Code: NBW, Blood Glucose test system, over the counter LFR, Glucose Dehydrogenase, glucose
Panel: Clinical chemistry (75)
Intended Use
Intended use(s): See indication(s) for use below
Cambridge Sensors Limited
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Indication(s) for use:
The microdot 9 Home Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use only), by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is intended for "single patient-home use" only and should not be shared. It should be used only for testing fresh capillary whole blood samples from a fingerstick or palm for glucose (sugar). Alternate site testing should be done only during steady-state times (when glucose is not changing rapidly). It is not intended for use on neonates or in the diagnosis of or screening for diabetes mellitus.
The system consists of the microdot Home Blood Glucose meter, microdot 8 Home Test Strips and microdot® Control solutions.
microdot® Home Test Strips
The microdot 8 Home Test strips are intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick or palm.
Special conditions for use statements(s):
This product is intended for over-the-counter. Fingerstick testing only (no palm testing) should be performed if blood glucose level is changing rapidly as follows:
- Within 2 hours after a meal ◆
- Within 2 hours after insulin dosing .
- Patients with a history of hypoglycaemia, experiencing symptoms of low sugar or suffer from hypoglycaemic unawareness.
Special instrument requirements:
microdot® Home Blood Glucose Meter
Device Description:
The microdot® Home Blood Glucose Monitoring System consists of the microdot® Home Blood Glucose Meter, microdote Home Test Strips, microdot Control Solutions and a commercially available (510(k) cleared) lancing device and lancets. A clear cap is provided with the lancing device for alternate site testing on the palm. microdote Home Blood Glucose Monitoring System is for a single patient use only. The meter and lancing device must not be shared with anyone.
microdot® Home is an auto code system. The meter turns on upon insertion of the strip, a blood sample from the finger or palm is applied to the test strip and after 10 seconds, the plasma glucose result is displayed on the screen in mg/dL only.
microdot Home Blood Glucose Monitoring System is substantially equivalent in form, firmware, fundamental scientific technology and specifications as the predicate system, microdot® Xtra Blood Glucose Monitoring System. It relies on quantitative
Cambridge Sensors Limited
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510(k) Summary
electrochemical biosensor technology to measure current generated on disposable test strips.
The strip remains unchanged since the last submission approval, microdot® Xtra Blood Glucose Monitoring System (K083273). The Test Strip manufacturing and performance characteristics are unchanged. The test strips are designed to quantitatively measure glucose in fresh capillary blood from the fingertip by persons with diabetes.
Substantial Equivalence Information:
Predicate device name (s):
microdot® Blood Glucose Monitoring System, 510(k) Number :K070524
microdot® Xtra Blood Glucose Monitoring System, 510(k) Number:K083273 Comparison with predicate:
microdot® Home Test Strips share the same design, functionality, raw materials and manufacturing process as. microdof® Xtra Test Strips.
| Device 1 | Predicate 1 | Predicate 2 | |
|---|---|---|---|
| Product Name | microdot® Home | microdot®(K070524) | microdot® Xtra(K083273) |
| Code | No code number | Code Number foreach lot of strips | No code number |
| Enzyme | GlucoseDehydrogenase/NAD | Same | Same |
| Sample | Fresh Capillary wholeblood | Same | Same |
| Blood Source | Finger, Palm | Finger | Finger |
| Test Principle | Electrochemical Biosensor | Same | Same |
| Calibration | Plasma equivalent | Same | Same |
| Sample volume | 600nanoliters | Same | Same |
| Temperature andhumidity range | 10°- 40°C10-90% RH | Same | Same |
| Hematocrit range | 30-50% | Same | Same |
| MeasurementRange | 25 - 525 mg/dL | Same | Same |
| Control Solution | Low, Normal, High | Same | Same |
Comparison to Predicate Devices:
Standard/Guidance Document referenced (if applicable):
ISO15197:2003: in vitro diagnostic test systems- requirements for blood-glucose monitoring systems for self testing in managing diabetes mellitus (Section 8: User Performance)
Test Principle
Cambridge Sensors Limited
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510(k) Summary
The test is based on the enzymatic conversion of glucose in the sample to gluconolactone, with concomitant reduction of the enzyme cofactor NAD* to NADH. The NADH is re-oxidised to NAD* by the mediator compound which in turn becomes reduced; re-oxidation of the mediator by the meter induces a micro current to flow, and the size of this micro current is directly proportional to the amount of glucose in the sample. Unlike PQQ dependent Glucose Dehydrogenase, the NAD-dependent Glucose Dehydrogenase enzyme used in the microdor® Home test strips is specific to glucose and has no interference from galactose and maltose.
Performance Characteristics
- Analytical Performance
Precision/ Reproducibility Established in original submission (K070524)
Linearity/assay reportable range Established in original submission (K070524)
Traceability, Stability', Expected values (controls, calibrators, or methods) Established in original submission (K070524)
Detection Limit Established in original submission (K070524)
Analytical Specificity · Established in original submission (K070524)
Assay Cut-off Not applicable
- Comparison Studies
Comparison with predicate device Established in original submission (K070524)
Alternate Site Testing at Palm
A consumer study was performed with 152 diabetics testing themselves both at finger and alternate site and healthcare professionals testing at finger only to see if the results obtained at the alternate site is comparable with the finger. The diabetics obtained the samples and carried out the tests using the instructions provided. The samples ranged from 48 to 367 mg/dL. The palm results were comparable to finger results.
Cambridge Sensors Limited
Page 4 of 5
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| Summary of Accuracy Results for all sites tested | |||
|---|---|---|---|
| Sites tested | For glucose levels < 75mg/dL | ||
| Within +/- 5mg/dL | Within +/- 10mg/dL | Within +/- 15mg/dL | |
| * Subject Palm Accuracy vs YSI | 0 (3) 0% | 2 (3) 67% | 3 (3) 100% |
| Subject finger Accuracy vs YSI | 1 (3) 33% | 3 (3) 100% | 3 (3) 100% |
| HCP finger. Accuracy vs YSI | 1 (3) 33% | 3 (3) 100% | 3 (3) 100% |
| Summary of Accuracy Results for all sites tested | |||||
|---|---|---|---|---|---|
| Sites tested | For glucose levels ≥75mg/dL | Within +/- 5% | Within +/- 10% | Within +/- 15% | Within +/- 20% |
| Subject Palm Accuracy vs YSI | 61 (149) 41% | 109 (149) 73% | 134 (149) 90% | 146 (149) 98% | |
| Subject finger Accuracy vs YSI | 76 (149) 51% | 121 (149) 81% | 138 (149) 93% | 144 (149) 97% | |
| HCP finger Accuracy vs YSI | 62 (149) 42% | 116 (149) 78% | 138 (149) 93% | 146 (149) 98% |
3. Disinfection Studies
Dispatch Hospital Cleaner Disinfectant wipes with Bleach with EPA registration # 56392-8 was validated demonstrating complete inactivation of Hepatitis B virus. It was demonstrated that there was no change in performance or in the external materials of the meter and lancing device for a minimum of 375 cycles equivalent to a pre-clean and disinfection cycle of once per week for 5 years for a single patient use only meter.
Conclusion
The study supports substantial equivalence to a predicate device and the addition of palm testing as an alternate testing site for blood glucose testing.
Cambridge Sensors Limited
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures, possibly symbolizing health and well-being.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
CAMBRIDGE SENSORS LIMITED c/o Dr. Bernadette Yon-Hin Units 9 & 10 Cardinal Park Godmanchester Huntingdon, Cambridgeshire United Kingdom PE29 2XG
JAN 2 7 2012
K102383 Re:
Trade Name: microdot® Home Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, LFR Dated: January 5, 2012 Received: January 9, 2012
Dear Dr. Yon-Hin:
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 Eederal 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance...
You may obtain other general information on your responsibilities under the Act from the Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
signature
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): K102383
Device Name: microdot® Home Blood Glucose Monitoring System
Indication for Use:
The microdot 9 Home Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use only), by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is intended for "single patient-home use" only and should not be shared. It should be used only for testing fresh capillary whole blood samples from a fingerstick or palm for glucose (sugar). Alternate site testing should be done only during steady-state times (when glucose is not changing rapidly). It is not intended for use on neonates or in the diagnosis of or screening for diabetes mellitus.
The system consists of the microdot® Home Blood Glucose meter, microdot® Home Test Strips and microdot® Control solutions.
microdot® Home Test Strips
The microdot® Home Test strips are intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick or palm.
Over the Counter Use YES And/Or Prescription Use (21 CFR Part 801 Subpart C) (21 CFR Part 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
102383
§ 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.