Search Results
Found 2 results
510(k) Data Aggregation
(148 days)
The One Drop Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose (sugar) levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The One Drop 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 One Drop Blood Glucose Monitoring System is not for the diagnosis of, or diabetes, and is not intended for use with neonates.
The One Drop Blood Glucose Test Strips:
The One Drop Blood Glucose Test Strips are for use with the One Drop Blood Glucose Meter to quantitatively measure blood glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The One Drop Blood Glucose Monitoring System (BGMS) is intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The One Drop BGMS 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 System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates.
The system measures the concentration of glucose in a drop of blood obtained from the fingertip. The test strip is inserted into the meter and the blood is then introduced to the tip of the test strip. The blood reacts with chemicals on the test strip and this reaction generates an electrical current which is measured by the meter. The magnitude of the current is related to the blood glucose concentration. The fundamental scientific technology and the electronics that sends the electrical signals to the assay algorithm are all the same as the predicate device AgaMatrix Jazz Wireless 2 BGMS (K152365). The unit of measure displayed on the meter screen is fixed in mg/dL and cannot be modified by the user.
The One Drop Blood Glucose Monitoring System (BGMS) consists of:
- 1 One Drop Blood Glucose Meter ●
- 1 One Drop Owner's Guide ●
- 1 Carry Case
- 1 Lancing Device
- 10 Lancets
- 100 One Drop Glucose Test Strips ●
- AgaMatrix Glucose Control Solution (available separately) ●
The provided text describes the One Drop Blood Glucose Monitoring System (BGMS) and its submission for FDA 510(k) clearance. The document focuses on demonstrating substantial equivalence to a predicate device, the AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System (K152365).
Based on the information provided, here is the breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list "acceptance criteria" for the device's performance in a table format with corresponding "reported device performance." Instead, it establishes substantial equivalence by demonstrating that the One Drop BGMS has the same performance characteristics as the predicate device. The performance characteristics are implicitly considered "acceptance criteria" because they mirror those of the already-cleared predicate.
| Performance Characteristic | Acceptance Criteria (from Predicate) | Reported Device Performance (One Drop BGMS) |
|---|---|---|
| Sample Type | Capillary whole blood | Same |
| Sample Sites | Fingertip | Same |
| Sample Volume | 0.5 µL | Same |
| Average Test Time | 5 seconds | Same |
| Test Range | 20 - 600 mg/dL | Same |
| Operating Temperature | 50° - 104°F | Same |
| Measurement Range | 20 to 600 mg/dL | Same |
| Calibration | Plasma Equivalent | Same |
| Control Levels | Two Levels | Same |
| Operating Humidity | 10% to 90% | Same |
| Hematocrit Range | 20 - 60% | Same |
| Altitude Study | Up to 10,000 feet | Same |
| Power Source | (2) replaceable CR2032 3 volt, lithium batteries | Same |
| Connectivity | Meter can send BGM results via Bluetooth to smart devices using appropriate iOS or Android software application. | Same |
| Detection method | Dynamic Electrochemistry | Same |
| Enzyme | Glucose Oxidase | Same |
| Calibration Coding | Non-Coding | Same |
The document explicitly states: "The fundamental scientific technology and the electronics that sends the electrical signals to the assay algorithm are all the same as the predicate device AgaMatrix Jazz Wireless 2 BGMS (K152365)." And "The device modifications described in this premarket notification do not affect or alter the fundamental scientific technology of the predicate device, the AgaMatrix Jazz Wireless 2 Blood Glucose Monitor." This implies that the device's performance is expected to be identical to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for any performance testing of the One Drop BGMS, nor does it provide information on data provenance (e.g., country of origin, retrospective or prospective). The document relies on demonstrating substantial equivalence to the predicate device, implying that extensive de novo testing that would require such details might not have been included in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since this is a submission for a blood glucose monitoring system, the "ground truth" for glucose measurements is typically established through a laboratory reference method (e.g., YSI analyzer) performed by trained laboratory technicians, not clinical "experts" in the sense of radiologists.
The document does not provide details on the number of laboratory personnel or their specific qualifications for establishing the ground truth for any testing conducted for the One Drop BGMS.
4. Adjudication Method for the Test Set
As the "ground truth" for blood glucose measurements is generally an objective laboratory reference method, an "adjudication method" involving multiple human readers as described (e.g., 2+1, 3+1) is not applicable to this type of device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is relevant for devices where human interpretation plays a significant role in diagnosis or decision-making (e.g., imaging studies). For a blood glucose monitoring system, which provides a direct numerical reading, an MRMC study comparing human readers with and without AI assistance is not applicable. The device is intended for self-testing by individuals with diabetes, not for interpretation by multiple clinical experts.
6. Standalone Performance Study
The provided document does not explicitly describe a standalone (algorithm only) performance study for the One Drop BGMS with detailed metrics. The submission focuses on establishing substantial equivalence to a predicate device, which implies that the underlying technology's standalone performance characteristics were already validated with the predicate. The document states that the fundamental scientific technology and electronics are the same as the predicate.
7. Type of Ground Truth Used
For blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method for glucose measurement, such as a YSI glucose analyzer, which provides highly accurate and precise glucose values in blood samples. Details of this are not explicitly stated for the One Drop BGMS but would be standard for this type of device.
8. Sample Size for the Training Set
The document does not provide information on the sample size used for any training set. Given the focus on substantial equivalence, if machine learning or AI was used in the development (which is not explicitly stated beyond "assay algorithm"), the training details are not disclosed in this summary.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for any training set was established. As with testing, if a training set were used for an algorithm, the ground truth would typically be established by a laboratory reference method.
Ask a specific question about this device
(244 days)
The AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose (sugar) levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The AgaMatrix Jazz ™ Wireless 2 Blood Glucose Monitoring System is intended for selftesting outside the body (In vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates.
The AgaMatrix Jazz™ Blood Glucose Test Strips are for use with the AgaMatrix Jazz™ Wireless 2 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
The AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System includes the AgaMatrix Jazz™ Wireless 2 Blood Glucose Meter and the AgaMatrix Jazz™ Blood Glucose Test Strips. The apply blood symbol is displayed for the user to apply blood to the test strip until the meter begins the test. When enough blood has been applied to the strip electrodes the meter detects trigger current from the test strip initiating the test countdown. When the countdown is complete a test result is displayed on the meter screen. The unit of measure displayed on the meter screen is fixed in mg/dL and cannot be modified by the user.
The following items are included in the AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System:
- 1 AgaMatrix Jazz™ Wireless 2 Glucose Meter .
- . 1 Owner's Guide
- . 1 Carry Case
- 1 AgaMatrix Lancing Device .
- . 10 AgaMatrix Lancets
- AgaMatrix Jazz™ Blood Glucose Test Strips -
- -1 Meter Pairing & Syncing Guide
The following items are compatible with the AgaMatrix Jazz™ Wireless 2 Glucose Monitoring System and are available separately:
Here's a summary of the acceptance criteria and the study details for the AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System, extracted from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a single consolidated table with corresponding performance. However, based on the Performance Characteristics section, the implicit acceptance criteria are derived from standard deviations, coefficients of variation (CV%), and percentages of agreement within certain error ranges when compared to a reference method (YSI 2300 Glucose Analyzer).
Analytical Performance (Precision/Reproducibility):
| Glucose Concentration (mg/dL) | Acceptance Criteria (Implicit from Industry Standards/FDA Guidance) | Reported Device Performance (CV%) |
|---|---|---|
| 30-50 | Not explicitly stated, but generally low CV% is desired | Combined: 9.0% (SD: 2.9 mg/dL) |
| 51-110 | Not explicitly stated, but generally low CV% is desired | Combined: 4.3% (SD: 4.2 mg/dL) |
| 111-150 | Not explicitly stated, but generally low CV% is desired | Combined: 3.2% (SD: 4.1 mg/dL) |
| 151-250 | Not explicitly stated, but generally low CV% is desired | Combined: 3.5% (SD: 7.7 mg/dL) |
| 251-400 | Not explicitly stated, but generally low CV% is desired | Combined: 4.0% (SD: 15.3 mg/dL) |
| Intermediate Precision | ||
| Control Level 1 (57 mg/dL) | Not explicitly stated, but generally low CV% is desired | Lot 1: 2.8%, Lot 2: 3.7%, Lot 3: 3.1% |
| Control Level 2 (134-137 mg/dL) | Not explicitly stated, but generally low CV% is desired | Lot 1: 2.6%, Lot 2: 2.1%, Lot 3: 2.3% |
| Control Level 4 (342-345 mg/dL) | Not explicitly stated, but generally low CV% is desired | Lot 1: 2.5%, Lot 2: 2.6%, Lot 3: 2.2% |
Method Comparison (System Accuracy) with YSI Reference:
This part of the study is crucial for demonstrating device accuracy against a recognized standard. The acceptance criteria for blood glucose monitoring systems are typically based on ISO 15197:2013, which specifies accuracy requirements. Although the document doesn't explicitly refer to ISO 15197, the presentation of results in terms of percentage agreement within specific limits (e.g., ±5 mg/dL, ±15%) aligns with these standards.
| Glucose Concentration | Acceptance Criteria (Implied based on typically adopted standards for BGMS) | Reported Device Performance (Combined) |
|---|---|---|
| < 75 mg/dL | ≥95% of results within ±15 mg/dL of reference | 99.0% (95/96) within ±15 mg/dL |
| ≥ 75 mg/dL | ≥95% of results within ±15% of reference | 97.5% (269/276) within ±15% |
User Performance Study (System Accuracy by Lay Users):
| Glucose Concentration | Acceptance Criteria (Implied based on typically adopted standards for BGMS) | Reported Device Performance |
|---|---|---|
| < 75 mg/dL | ≥95% of results within ±15 mg/dL of reference | 100.0% (4/4) within ±15 mg/dL |
| ≥ 75 mg/dL | ≥95% of results within ±15% of reference | 94.8% (91/96) within ±15% |
Note: While the lay user study reported 94.8% within ±15% for ≥75 mg/dL, the document concludes that "all AgaMatrix Jazz™ Wireless 2 BGMS performance criteria were met." This implies that 94.8% was considered acceptable or within an allowable margin for this specific study, or perhaps the overall performance across all criteria was sufficient for substantial equivalence.
2. Sample Sizes and Data Provenance
Test Set (Method Comparison):
- Sample Size: 124 whole blood samples (117 fresh capillary fingerstick, 7 altered blood samples).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the study involves fresh capillary samples and altered blood samples, suggesting a prospective, controlled laboratory setting.
Test Set (User Performance Study):
- Sample Size: 100 lay users with Type 1 or Type 2 diabetes. Each user contributed samples, but the total number of individual glucose measurements or cases is not explicitly stated beyond implying "samples from the finger." The reported results (4/4 for <75 mg/dL and 96 for ≥75 mg/dL) suggest a total of 100 measurements (4 + 96 = 100 observations).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The nature of a "lay user study" implies prospective data collection from individuals.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable in the context of blood glucose monitoring systems accuracy studies.
- Qualifications of Experts: Not applicable.
For blood glucose monitoring systems, ground truth is established by a highly accurate reference instrument, not by expert human graders.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable.
Since the ground truth is established by a reference instrument (YSI 2300 Glucose Analyzer), there is no need for human adjudication of results to establish ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done?: No.
- Effect Size: Not applicable.
MRMC studies are typically used for imaging diagnostics where human readers interpret medical images. This is not relevant for a blood glucose monitoring system, where the device provides a quantitative numerical output. The "user performance study" evaluates the device's accuracy when operated by lay users, which is a different type of assessment than an MRMC study.
6. Standalone Performance Study (Algorithm Only)
- Was it done?: Yes, multiple studies were performed to evaluate the standalone performance of the device.
The entire "Analytical performance" section (Precision/Reproducibility, Linearity, Analytical Specificity) and the "Method comparison with predicate device" describe the standalone performance of the device compared to a reference method, without human interpretation of results. The "User Performance Study" also assesses the device's standalone accuracy in the hands of the intended users.
7. Type of Ground Truth Used
- Type of Ground Truth: Reference instrument measurement.
For all accuracy studies (precision, linearity, method comparison, and user performance), the device's results were compared to those obtained from the YSI Model 2300 Glucose Analyzer, which serves as the gold standard reference method for glucose concentration. The calibration of the device is also traceable to NIST SRM 917c.
8. Sample Size for the Training Set
- Sample Size: Not explicitly stated for a "training set."
Blood glucose monitoring systems like this one are typically calibrated during manufacturing rather than "trained" in the way AI/ML models are. The linearity study (with 12 prepared venous blood samples tested in 12 replicates for 3 lots, totaling 12 x 12 x 3 = 432 measurements) and other analytical studies contribute to the overall validation and calibration, but not in the "training set" sense of machine learning.
9. How the Ground Truth for the Training Set Was Established
- How Established: For glucose monitoring systems, calibration is typically performed during manufacturing using known glucose standards.
The document states, "The device is factory calibrated. Further calibration by the user is not necessary for operation. The calibration is traceable to NIST SRM 917c." This indicates that the ground truth for calibration (which would be analogous to a training set in a different context) is established through highly accurate, traceable chemical standards.
Ask a specific question about this device
Page 1 of 1