Search Results

The CERA-CHEK 1070 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, forearm, upper arm, palm, thigh, or calf. The CERA-CHEK 1070 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The CERA-CHEK 1070 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes controls. The CERA-CHEK 1070 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The CERA-CHEK 1070 Blood Glucose Test Strips are for use with the CERA-CHEK 1070 Blood Glucose Test Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, forearm, upper arm, palm, thigh, or calf.

The CERA-CHEK 1070 Control Solution is for use with the CERA-CHEK 1070 Blood Glucose Test Meter and Test strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.

The CERA-CHEK Diabetes Management Software is PC-based software intended for use in home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose results for effective diabetes management. It is intended for use as an accessory to compatible CERAGEM MEDISYS blood glucose monitoring systems. The CERA-CHEK Diabetes Management Software's language is English.

The CERA-CHEK 1070 Blood Glucose Monitoring System consists of the CERA-CHEK 1070 Glucose Test Meter, CERA-CHEK 1070 Blood Glucose Test Strips with Code Key, CERA-CHEK 1070 Control Solution 1 and Control Solution 2, a Lancing device, and CERA-CHEK Diabetes Management Software and cable needed for installing the software on the PC and for transmitting data from meter. Control Solution 1 and Control Solution 2 are required but not included with the meter. Control Solution 1 and Control Solution 2 are always provided as a set. CERA-CHEK Diabetes Management Software and cable are required but not included with the meter. CERA-CHEK Diabetes Management Software and cable are always provided as a set.

1. Acceptance Criteria and Reported Device Performance:

The document primarily focuses on the analytical performance and system accuracy of the CERA-CHEK 1070 Blood Glucose Monitoring System. The acceptance criteria are implicitly defined by the reported performance relative to a reference method (YSI 2300 analyzer) and the ranges tested.

Table 1: Acceptance Criteria (Implied) and Reported Device Performance

• CV (%) range: 2.2% - 5.2% |
  | Day-to-day Precision | Low CV% for control samples across different glucose levels | Glucose concentration 43-304 mg/dL:
• CV (%) range: 2.8% - 5.5% |
  | Linearity (r^2) | Close to 1.0, supporting claimed measurement range | Slope: 0.9782 - 0.9896
  Intercept: 1.4433 - 4.4741
  Corr Coeff (r^2): 0.9992 - 0.9997 (supports 20-600 mg/dL range) |
  | Measurement Range | 20-600 mg/dL | 20-600 mg/dL (validated by linearity study) |
  | System Accuracy (Technician vs YSI) | = 75 mg/dL: 100% within +/-20%; high percentage within +/-5%/10%/15% | = 75 mg/dL (n=171):
• 58% within +/-5%
• 82% within +/-10%
• 96% within +/-15%
• 100% within +/-20% |
  | System Accuracy (Lay User vs YSI) | = 75 mg/dL: 100% within +/-20%; high percentage within +/-5%/10%/15% | = 75 mg/dL (n=162):
• 56% within +/-5%
• 76% within +/-10%
• 94% within +/-15%
• 100% within +/-20% |
  | Alternate Site Testing | Similar accuracy to fingertip testing, within specified error margins for professional and lay users. | Professional (n=5 for =75): Generally good accuracy across palm, forearm, upper arm, thigh, calf (e.g., 93-98% within +/-15% for >=75 mg/dL).
  Lay User (n=5 for =75): Generally good accuracy across palm, forearm, upper arm, thigh, calf (e.g., 93-97% within +/-15% for >=75 mg/dL). |
  | Hematocrit Range | Accurate results over the claimed range (10 - 70%) | Demonstrated accurate results for 10-70% hematocrit. |
  | Altitude | Accurate results up to 13,200 feet | Demonstrated accurate results up to 13,200 feet. |
  | Temperature and Humidity | Accurate results across claimed temperature (10-40°C) and humidity (10-85%) ranges | Demonstrated acceptable bias for 10-40°C and 10-85% RH. |
  | Interference | No significant interference from listed substances at specified concentrations | Listed substances found not to interfere at specified concentrations (e.g., Acetaminophen up to 6 mg/dL, Bilirubin up to 4 mg/dL, Triglyceride up to 1,500 mg/dL). Specific limitations noted for dopamine, methyldopa, tolazamide, and xylose. |
  | Shelf-life Stability | 24 months (closed vial); 4 months (open vial) | Test strip shelf-life of 24 months (closed vial) and 4 months (open vial) supported. |
  | Control Solution Stability | 12 months (closed vial); 4 months (open vial) | Control solution shelf-life of 12 months (closed vial) and 4 months (open vial) supported. |

2. Sample Sizes and Data Provenance:

• Test Set Sample Sizes:
  • Within-run Precision: For each of 5 glucose concentrations, 5 strip lots, and 10 meters, there were 10 measurements per strip lot per meter. This totals 5 * 5 * 10 * 10 = 2500 measurements. (The text states "a total of 100 measurements per glucose concentration", which seems to contradict the previous sentence unless it's per meter type across strip lots, or a summary. Taking the more detailed description, it's 2500 total).
  • Day-to-day Precision: For each of 3 control levels, 1 strip lot (per glucose level, so effectively 3 lots used in total), and 10 meters, measured once per day over 20 days. This totals 3 * 1 * 10 * 20 = 600 measurements per each of the three levels, for a grand total of 1,800 measurements.
  • Linearity/Assay Reportable Range: 9 (or 10) glucose samples, each analyzed 5 times using 3 lots of test strips. This would be 9 (or 10) * 5 * 3 = 135 to 150 measurements.
  • System Accuracy Study (Technician vs YSI):
    • Fingertip samples: 200 participants (collected and tested twice by themselves, and once by healthcare professional).
    • Contrived samples: 20 samples.
    • Total sample comparisons to YSI for technician: 171 (≥75 mg/dL) + 47 (= 75 mg/dL, for both professional and lay users.
  • Hematocrit Study: Five measurements for each combination of glucose concentration and hematocrit level (specific total N not given, but glucose range 21-529 mg/dL and hematocrit range 10-70%).
  • Altitude Study: Three lots of test strips and three meters were used (specific total N not given, but 3 glucose concentrations).
  • Temperature and Humidity Studies: Three test strip lots, three glucose concentrations, twelve combinations of temp/humidity, replicates of three for each combination/glucose/meter (specific total N not given).
  • Interference Studies: Whole blood from healthy volunteers (exact number of volunteers not specified, but multiple glucose levels and interferent concentrations tested).
• Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether it was retrospective or prospective. However, given the manufacturer is based in Korea (Republic of Korea), it is highly probable the studies were conducted there. The studies appear to be prospectively designed clinical and analytical performance studies conducted specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth: No specific number of experts are explicitly stated as establishing the ground truth for the test set in the way one might for diagnostic imaging studies.

• For the analytical and system accuracy studies, the "ground truth" was established by laboratory reference methods, specifically the YSI 2300 Glucose analyzer for glucose measurements. The YSI 2300 is calibrated using a NIST traceable glucose standard, implying a highly accurate and standardized method for ground truth determination.
• For the usability study, "untrained lay users" were involved, but their assessment was on the "readability of the labeling" and "ease of use," not on establishing diagnostic ground truth.

4. Adjudication Method for the Test Set: Not applicable. The ground truth for the glucose measurements was established by a single, highly accurate laboratory reference method (YSI 2300), not through a consensus or adjudication process among multiple human experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done. The studies assessed the standalone performance of the device (both technician and lay user operated) against a reference method. There is no comparison of "human readers improve with AI vs without AI assistance" as this is a blood glucose meter, not an AI-assisted diagnostic imaging device for human interpretation.

6. Standalone (Algorithm Only) Performance: Yes, standalone performance was done for the device in the context of a blood glucose meter. The "Technician vs YSI" data directly represents the standalone performance of the device when operated by a trained professional against the gold standard (YSI). The "Lay User vs YSI" data represents the performance when operated by the intended end-user.

7. Type of Ground Truth Used:
The primary ground truth used throughout the performance studies (precision, linearity, system accuracy, alternate site testing, hematocrit, altitude, temperature/humidity, interference) was laboratory reference method measurements obtained from the YSI 2300 Glucose analyzer, which is calibrated using a NIST traceable glucose standard. This is a highly objective and quantitative ground truth.

8. Sample Size for the Training Set: The document does not specify a separate "training set" sample size. For medical devices like blood glucose meters, the development and calibration ("training") of the device's algorithms or underlying chemical reactions often occur prior to these validation studies. These studies primarily serve as external validation or "test sets" to demonstrate the final product's performance. The information provided heavily details these validation studies.

9. How Ground Truth for the Training Set Was Established: As above, specific details on a "training set" and its ground truth establishment are not provided in this 510(k) summary. The development process would typically involve extensive internal testing and calibration against reference methods (like the YSI 2300) to fine-tune the device's performance before formal validation studies are conducted. The traceability to the YSI 2300 analyzer and NIST traceable glucose standard suggests that this highly accurate reference method would have been central to any internal calibration or "training" process.

Ask a specific question about this device