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510(k) Data Aggregation
(79 days)
CERAGEM MEDISYS INC.
The GlucoVitaal H1A 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, thigh, or calf. The GlucoVitaal H1A 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 GlucoVitaal H A 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 Gluco Vitaal H1 A Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The GlucoVitaal H1A Blood Glucose Test Strips are for use with the Glood 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 GlucoVitaal H1A Glucose Control Solution is for use with the GlucoVitaal H1A 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 GlucoVitaal H1A Blood Glucose Monitoring System consists of GlucoVitaal H1A Blood Glucose Test Meter, GlucoVitaal H1A Blood Glucose Test Strips, GlucoVitaal H1A Glucose Control Solution 1 and Control Solution 2, a Lancing device. 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.
The provided text describes a 510(k) premarket notification for the GlucoVitaal H1A Blood Glucose Monitoring System, seeking substantial equivalence to a predicate device (CERA-CHEK 1070 Blood Glucose Monitoring System).
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a regulated performance standard. Instead, it aims to demonstrate substantial equivalence to a predicate device by comparing various specifications. The "reported device performance" is not given as numerical results against predefined criteria, but rather as statements of identical or similar specifications to the predicate device.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (GlucoVitaal H1A) |
|---|---|
| Detection Method | Amperometry (Same as Predicate) |
| Enzyme | Glucose dehydrogenase (FAD-GDH) (Same as Predicate) |
| Test Time | 5 seconds (Same as Predicate) |
| Memory | 1000 blood glucose test results with date and time (Same as Predicate) |
| Sample Volume | 0.5 uL (Same as Predicate) |
| Humidity range | 10-85% (Same as Predicate) |
| Temperature range | 50-104°F (10-40°C) (Same as Predicate) |
| Power (Battery) | One 3-volt lithium battery (CR2032) (Same as Predicate) |
| Test range | 20-600 mg/dL (Same as Predicate) |
| Level of QC | 2 Levels (Control 1, Control 2) (Same as Predicate) |
| Dimensions | 94mm(H) x 53.6(W) x 14.9mm(T) (Same as Predicate) |
| Weight | 35g (Same as Predicate) |
| Hematocrit range | 10-70% (Same as Predicate) |
| Code Setting | No code (Predicate device required a code key; candidate device has one built-in) |
| Language | English, Spanish and Portuguese (Predicate device only had English) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for any test set or the data provenance. It focuses on comparing specifications and features for substantial equivalence, rather than presenting a performance study with detailed results from a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The submission is for a blood glucose monitoring system, which typically relies on laboratory reference methods (e.g., YSI analyzer) for ground truth, not expert human readers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided in the document given the nature of the device and the substantial equivalence claim. Adjudication methods are typically relevant for image-based diagnostic systems where human interpretation can vary.
5. 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
An MRMC comparative effectiveness study is not applicable and not mentioned in the document. This type of study is relevant for AI-assisted diagnostic tools involving human interpretation, which is not the case for a blood glucose monitoring system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
While the device itself operates "standalone" in measuring glucose, the document does not describe a specific performance study in terms of an algorithm-only evaluation. Instead, it asserts that the modification of code setting (from code key to no code) would have "no effect on the performance test," implying that prior performance data (likely from the predicate device) is considered relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used for any performance evaluation. However, for blood glucose monitoring systems, the ground truth is typically established using a highly accurate laboratory reference method, such as a YSI glucose analyzer.
8. The sample size for the training set
The document does not mention a training set or its sample size. This is a 510(k) submission focused on substantial equivalence to an existing device, not the development and training of a novel algorithm from scratch.
9. How the ground truth for the training set was established
Since no training set is mentioned, the method for establishing its ground truth is not provided.
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(162 days)
CERAGEM MEDISYS INC.
The LabonaCheck® Gluppy 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. The LabonaCheck® Gluppy Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The LabonaCheck® Gluppy 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 control. The LabonaCheck® Gluppy Blood Glucose Monitoring System should not be used for the diagnosis or screening of diabetes or for neonatal use.
The LabonaCheck® Gluppy Blood Glucose Test Strips are for use with the LabonaCheck® Gluppy Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
The system consists of Test Meter, Test Strips, Lancing Device, lancets, 3 V battery and Carrying Case. The system measures the amount of glucose (sugar) in whole blood. Blood is applied to the absorbent hole of the test strip and automatically drawn into the reaction zone where reaction between reagent and glucose occurs.
The provided text is a 510(k) summary for the LabonaCheck® Gluppy Blood Glucose Monitoring System. It does not contain information about the specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes for training/test sets, ground truth establishment, or expert involvement as requested.
The document primarily focuses on establishing substantial equivalence to a predicate device (K102751) by comparing various features and performance characteristics. It states that the "Performance Characteristics" are the same as the predicate and refers to "N. Performance Characteristics on 6 page" which is not provided in the input text.
Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, study design, and performance results. This document is a regulatory submission for premarket notification, not a detailed scientific study report.
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(261 days)
CERAGEM MEDISYS INC.
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
| Performance Characteristic | Acceptance Criteria (Implied by study design/expected standards for blood glucose meters) | Reported Device Performance |
|---|---|---|
| Within-run Precision | Low CV% across different glucose concentrations | Glucose concentration 30-400 mg/dL: |
- 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.
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(872 days)
CERAGEM MEDISYS INC.
The LabonaCheck Gluppy 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. The LabonaCheck Gluppy Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The LabonaCheck Gluppy 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 control. The LabonaCheck Gluppy Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use.
The LabonaCheck Gluppy Blood Glucose Test Strips are for use with the LabonaCheck Gluppy Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
The LabonaCheck Gluppy Control Solution is for use with the LabonaCheck Gluppy Blood Glucose Monitoring System as a quality control check to verify that the meter and test strips are working together properly.
The system consists of Test Meter, Test Strips, Code key, Lancing Device, lancets, 3V battery and Carrying Case.
The system measures the amount of glucose (sugar) in whole blood. Blood is applied to the absorbent hole of the test strip and automatically drawn into the reaction zone where reaction between reagent and glucose occurs.
The provided text is a 510(k) summary for the LabonaCheck Gluppy Blood Glucose Monitoring System. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, it does not contain any information about acceptance criteria, a specific study proving the device meets those criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or training set details.
The document is a regulatory submission for premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed device rather than providing detailed performance study results with specific acceptance criteria and statistical analysis.
Therefore, I cannot fulfill your request for the specific points about acceptance criteria and detailed study information based on the provided text. The document primarily focuses on:
- Device Name: LabonaCheck Gluppy Blood Glucose Monitoring System
- Manufacturer: CERAGEM Medisys Inc.
- Submission Date: February 11, 2013
- Predicate Device: RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, Model GM 100 (K081451)
- Indication for Use: Quantitative measurement of glucose in fresh capillary whole blood samples from the fingertip for self-testing by people with diabetes at home (not for diagnosis, screening, or neonatal use).
- Similarities to Predicate: Amperometry detection method, Glucose Oxidase enzyme, Potassium ferricyanide mediator, test range (20-600 mg/dL), temperature range (10-40°C), noble metal electrode, 3-year warranty, CR2032 battery.
- Differences from Predicate: Sample volume (1.0 uL vs 1.4 uL), humidity range (Below 80% vs 10-90%), open use time for test strips (4 months vs 3 months), coding (Code Key vs No coding), test time (5 seconds vs 8 seconds), hematocrit range (20-60% vs 30-55%), memory (500 results vs 10 results).
To answer your questions, a different type of document, such as a validation study report or a more detailed performance specification document, would be required.
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