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510(k) Data Aggregation
(133 days)
The GLUCOCARD® W onyx Blood Glucose Monitoring System is comprised of GLUCOCARD® W onyx Blood Glucose Meter and disposable GLUCOCARD® W Blood Glucose Test Strips.
The GLUCOCARD® W onyx Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip or palm. Testing is done outside the body (in vitro diagnostic use). It is intended for use at home by persons with diabetes, as an aid in monitoring the effectiveness of a diabetes control program.
The GLUCOCARD® W onyx Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The GLUCOCARD® W onyx Blood Glucose Monitoring System is designed to quantitatively determine glucose concentrations in fresh capillary whole blood samples. The GLUCOCARD® W onyx Blood Glucose Monitoring System consists of a battery-powered GLUCOCARD® W onyx Blood Glucose Meter, disposable GLUCOCARD® W Blood Glucose Test Strips and Assure® Control-Control Solution (Levels 1, 2, and 3). The GLUCOCARD® W onyx Blood Glucose Monitoring System utilizes biosensor technology for the quantitative determination of glucose concentrations in capillary blood samples. Although capillary blood samples are used for measurement, the results displayed on the GLUCOCARD® W onyx Blood Glucose Monitoring System are equivalent to plasma glucose levels.
The biosensor (GLUCOCARD® W Blood Glucose Test Strips) operates on the electrochemical detection of the reaction of glucose with the enzyme glucose oxidase.
Glucose in the blood reacts with the reagent in the test strip, and this produces a small electric current. The strength of this current is proportional to the concentration of glucose in the blood. The meter measures this current and calculates the glucose level in the blood.
The provided text describes the GLUCOCARD® W onyx Blood Glucose Monitoring System but does not contain information about acceptance criteria or specific study results demonstrating that the device meets those criteria.
The document is a 510(k) Summary, which aims to demonstrate substantial equivalence to a predicate device, rather than detailed performance study reports with acceptance criteria and results. While it lists various device features and compares them to the predicate device, it does not include any quantitative performance data, sample sizes for testing, ground truth establishment, or details about comparative effectiveness studies.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for test sets.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study details or effect size.
- Standalone performance details.
- Type of ground truth used (beyond implying plasma reference for glucose levels).
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily focuses on establishing substantial equivalence by highlighting design and functional similarities to the predicate device (GLUCOCARD® W Blood Glucose Monitoring System) and noting minor differences such as the addition of Bluetooth communication and changes in physical dimensions. It states that both devices "Have the same performance, measurement range, use environment and calibration functions," implying that the performance of the proposed device is expected to be the same as the predicate, which would have undergone performance testing at the time of its own clearance (K170064). However, the details of that performance testing are not included in this summary.
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(219 days)
The GLUCOCARD W Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip or palm. Testing is done outside the body (in vitro diagnostic use). It is intended for use at home by persons with diabetes, as an aid in monitoring the effectiveness of a diabetes control program.
The GLUCOCARD W Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The GLUCOCARD® W Blood Glucose Monitoring System is designed to quantitatively determine glucose concentrations in fresh capillary whole blood samples. The GLUCOCARD® W Blood Glucose Monitoring System consists of a battery-powered GLUCOCARD® W Blood Glucose Meter, disposable GLUCOCARD® W Blood Glucose Test Strips and Assure® Control-Control Solution (Levels 1, 2, and 3). The GLUCOCARD® W Blood Glucose Monitoring System utilizes biosensor technology for the quantitative determination of glucose concentrations in capillary blood samples. Although capillary blood samples are used for measurement, the results displayed on the GLUCOCARD® W Blood Glucose Monitoring System are equivalent to plasma glucose levels.
The biosensor (GLUCOCARD® W Blood Glucose Test Strips) operates on the electrochemical detection of the reaction of glucose with the enzyme glucose oxidase.
Glucose in the blood reacts with the reagent in the test strip, and this produces a small electric current. The strength of this current is proportional to the concentration of glucose in the blood. The meter measures this current and calculates your glucose level.
The document describes the performance testing of the GLUCOCARD® W Blood Glucose Monitoring System, an in vitro diagnostic device. The acceptance criteria and supporting studies are detailed below, primarily focusing on the accuracy of blood glucose measurements.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the accuracy of blood glucose measurements are derived from the 2016 FDA Guidance: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use. The reported device performance is based on the Finger-Stick Data Accuracy and Alternate Site (Palm) Data Accuracy studies.
| Criteria (Difference from True Blood Glucose Level) | Acceptance Criterion (FDA Guidance) | Reported Device Performance (Finger-stick) | Reported Device Performance (Alternate Site - Palm) |
|---|---|---|---|
| Within ± 5% | Not explicitly stated as a primary criterion for overall system accuracy in the provided text, but data is presented. | 63.7% (191/300) | 55.8% (134/240) |
| Within ± 10% | For glucose concentrations ≥ 100 mg/dL: ≥ 95% of results within ± 10%. For glucose concentrations < 100 mg/dL: ≥ 95% of results within ± 10 mg/dL. The document simplifies to "within ±X%" without specifying the concentration split for this table, so we use the overall percentage provided. | 92.7% (278/300) | 88.8% (213/240) |
| Within ± 15% | For glucose concentrations ≥ 100 mg/dL: ≥ 98% of results within ± 15%. For glucose concentrations < 100 mg/dL: ≥ 98% of results within ± 15 mg/dL. The document simplifies to "within ±X%" without specifying the concentration split for this table, so we use the overall percentage provided. | 99.0% (297/300) | 97.1% (233/240) |
| Within ± 20% | Not explicitly stated as a primary criterion for overall system accuracy beyond the 15% criterion, but data is presented. Implies acceptance if 98% meets 15% or 95% meets 10%. | 99.7% (299/300) | 99.2% (238/240) |
Accuracy at Extreme Glucose Values:
For extreme glucose values (below 80 mg/dL and greater than 250 mg/dL), 100% of the data points were within 15% of the reference analyzer result, meeting the 2016 FDA Guidance for Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use.
2. Sample Size Used for the Test Set and Data Provenance
- Finger-stick Data Accuracy:
- Sample Size: 300 lay-user participants.
- Data Provenance: Not explicitly stated regarding country of origin, but the studies were performed by ARKRAY, Inc., based in Japan, and presented to the FDA in the USA. The study design is prospective, involving user performance.
- Alternate Site (Palm) Data Accuracy:
- Sample Size: 240 lay-user participants.
- Data Provenance: Not explicitly stated regarding country of origin, but the studies were performed by ARKRAY, Inc., and presented to the FDA in the USA. The study design is prospective, involving user performance.
- Precision (Within-Run & Intermediate):
- Sample Size: 1,500 test strips (500 per test strip lot, 300 per glucose level) for both within-run and intermediate precision. Venous whole blood samples were spiked with glucose for within-run, and glucose control solutions were used for intermediate precision.
- Data Provenance: Not specified, likely internal laboratory testing.
- Linearity:
- Sample Size: 330 test strips (across 3 lots). Venous whole blood samples spiked with glucose.
- Data Provenance: Not specified, likely internal laboratory testing.
- Accuracy at Extreme Glucose Values:
- Sample Size: 100 prepared capillary whole blood samples (50 below 80 mg/dL and 50 above 250 mg/dL).
- Data Provenance: Not specified, likely internal laboratory testing.
- Interference:
- Sample Size: Not explicitly stated as a single number of samples, but involved 27 endogenous and exogenous substances tested with venous blood samples at three glucose levels (approx. 60, 120, and 250 mg/dL). Each sample was divided into test and control pools.
- Data Provenance: Not specified, likely internal laboratory testing.
- Hematocrit:
- Sample Size: 12 blood samples with varying hematocrit levels (20%-70%), each containing five glucose levels. A single glucose determination was made using 3 different lots of test strips with 10 different meters, resulting in 30 replicates per sample aliquot.
- Data Provenance: Not specified, likely internal laboratory testing.
- Environmental Conditions:
- Sample Size: Not explicitly stated as a single number of samples, but involved 10 meters and 3 test strip lots with venous whole blood samples at 3 glucose levels tested under various temperature and humidity conditions.
- Data Provenance: Not specified, likely internal laboratory testing.
- Altitude Effects:
- Sample Size: 360 tests (across 10 meters per test strip lot, 3 test strip lots, 6 blood glucose levels, 2 sample replicates per blood glucose level).
- Data Provenance: Tested under real-life altitude conditions at sea level and at 10,335 feet (3,150 meters) above sea level. Not specified where these locations are.
- Error Codes for Samples Outside Measuring Range:
- Sample Size: Not explicitly stated as a single number of samples, but involved venous blood samples with two glucose levels (≤ 10 mg/dL and 650-700 mg/dL) tested using 3 different lots of test strips with 10 different meters.
- Data Provenance: Not specified, likely internal laboratory testing.
- Short Sample Detection:
- Sample Size: Not explicitly stated.
- Data Provenance: Not specified, likely internal laboratory testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The ground truth for glucose measurements was established using a "YSI comparator" or "YSI reference analyzer" (YSI 2300 Biochemistry Analyzer). This is a laboratory-grade, highly accurate instrument for glucose measurement, considered the gold standard for glucose reference values in such studies. No human experts (e.g., radiologists) were involved in establishing the ground truth for glucose levels; it was an instrumental measurement.
4. Adjudication Method for the Test Set
Not applicable for this type of device. The ground truth is established by a reference instrument (YSI 2300), not by human interpretation or consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for image-based diagnostic aids where human readers interpret medical images with and without AI assistance (e.g., radiology AI). The GLUCOCARD® W Blood Glucose Monitoring System is a quantitative measurement device, not an image interpretation or AI-assisted diagnostic tool in that context. The "lay-user Participants" are performing the test themselves; their performance is compared against the reference method (YSI 2300), not against other human readers or AI output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
While the device's measurement principle (biosensor technology) is an "algorithm" in a broad sense, the performance studies described are inherently "human-in-the-loop" studies as they involve user operation (lay-users performing finger-stick and palm tests). The precision, linearity, interference, and extreme glucose values studies evaluate the meter and test strip system's performance, which can be seen as representing the "standalone" analytical performance of the device components when operated under controlled conditions, but always with a human providing the sample. The YSI 2300 reference analyzer itself serves as the "standalone" benchmark against which the device's output is compared.
7. The Type of Ground Truth Used
The ground truth used for all performance tests (accuracy, linearity, extreme values, interference, hematocrit, altitude, error codes) was established using a YSI 2300 Biochemistry Analyzer. This is an outcomes-based, highly accurate instrumental reference method considered a gold standard for glucose measurements.
8. The Sample Size for the Training Set
The document describes performance testing for device validation and substantial equivalence, not the development or "training" of an AI algorithm or a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The manufacturing process of GLUCOCARD® W Blood Glucose Test Strips involves calibration and quality control, but the document does not specify a "training set" in the sense of data used to train a statistical model or algorithm.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the AI/ML context, this question is not applicable. For the device itself, the "ground truth" for calibration and internal performance parameters would be established through a rigorous manufacturing and quality control process, likely referencing traceable standards and highly accurate laboratory methods such as the YSI 2300. The document mentions "Automatic coded calibration" for the meter, implying an internal calibration curve is established during manufacturing.
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(265 days)
The ADAMS A1c HA-8180V system is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood and hemolysate samples using Ion Exchange high performance liquid chromatography (HPLC).
Hemoglobin A1c measurements obtained from the ADAMS A1C HA-8180V are used as an aid in the diagnosis of diabetes mellitus, an aid in the identification of individuals who may be at risk of developing diabetes, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus. The ADAMS A1c HA-8180V is intended for Professional Use Only.
The CALIBRATOR 80 is for the calibration of the ADAMS A1c HA-8180V system used for the quantitative determination of hemoglobin A1c in human whole blood and hemolysate samples.
For In Vitro Diagnostic Use Only.
The ADAMS A1c HA-8180V system is a fully automated analyzer that uses ion exchange high performance liquid chromatography (HPLC) technology to separate glycated (labile A1c(L-A1c) and stable A1c (S-A1c)) and non-glycated (HbA0) forms of hemoglobin.
Hemoglobin A1c measurements obtained from the ADAMS A1C HA-8180V are used as an aid in the diagnosis of diabetes mellitus, an aid in the identification of individuals who may be at risk of developing diabetes, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus. The subject device consists of the ADAMS A1c HA-8180V test analytical instrument and CALIBRATOR 80, which is used to calibrate the HA-8180V. The ADAMS A1c HA-8180V system is for use in professional clinical laboratory settings.
This method is certified by the National Glycohemoglobin Standardization Program (NGSP).
Hemoglobin test samples are prepared by automated dilution of anticoagulated whole blood in Hemolysis Washing Solution 80H. Alternately, hemolysis samples may be prepared "off-line" by manual dilution of anticoagulated whole blood with Diluent 80. The sample is then injected into the column, which contains a filter to remove sample impurities. The differing polarity and ionic charges of the released hemoglobin fractions bind with variable strength to the negatively charged stationary phase of the column. The mobile phase, consisting of three eluents of increasing ionic strength, is injected into the column. Hemoglobin fractions eluted from the column are identified and quantified using light absorption, and are measured at 420 nm and 500 nm. The dual wavelength colorimetric analysis of the separated peaks is processed by a microcomputer to obtain peak identification and hemoglobin fraction quantitation. All pre-analytical and analytical steps are performed automatically by the ADAMS A1c HA-8180V system. Tests may be ordered in batch or for STAT measurement.
HbA1c and HbF results are reported in the presence of HbC, HbD, HbE, or HbS. A result of the detected HbC or HbS, and a peak resulting from HbD or HbE is also listed in the peak information. When a peak resulting from HbD or HbE is detected, a 'V' is listed in the peak information. HbA1c and HbF results are not reported when the instrument detects other peaks that affect HbA1c measurement value. The identification of any of these variants is not intended for use in diagnosis of hemoglobinopathies.
This document describes the validation study for the ADAMS A1c HA-8180V system, a device for quantitative determination of hemoglobin A1c.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Precision: Performance testing must use blood samples with concentrations near 5.0%, 6.5%, 8.0%, and 12% HbA1c, evaluated over a minimum of 20 days using at least three lots of the device and three instruments. | Precision demonstrated: The study used four donor samples at ~5.0%, ~6.5%, ~8.0%, and ~12.0% HbA1c, plus three quality control materials. It was evaluated using three reagent lots and three HA-8180V systems over 20 days, in duplicate, two runs per instrument per day. The total CV for whole blood samples combined across instruments ranged from 0.5% at 5.2% HbA1c to 1.0% at 11.8% HbA1c. For hemolysate samples combined across instruments, the total CV ranged from 0.4% at 5.2% HbA1c to 0.9% at 11.9% HbA1c. IFCC values also showed similar low CVs. |
| Accuracy (Method Comparison): Performance testing must include a minimum of 120 blood samples that span the measuring interval of the device and compare results of the new device to results of a standardized test method. | Accuracy demonstrated: A method comparison study included 143 variant-free whole blood K2-EDTA samples ranging from 4.1% to 17.7% HbA1c. These were compared against a secondary NGSP reference laboratory (Tosoh G8 HPLC method). The weighted Deming regression for whole blood showed a slope of 0.9864 and an R² of 0.998. For hemolysate, the slope was 0.9906 and R² was 0.998. The findings demonstrated little to no bias. |
| Total Error: Total error of the new device must be evaluated using single measurements by the new device compared to results of the standardized test method, and this evaluation must demonstrate a total error less than or equal to 6%. | Total Error demonstrated: Total Error (TE) was calculated at 5.0%, 6.5%, 8.0%, and 12.0% HbA1c using bias from method comparison and CV from precision studies. For whole blood, the %TE ranged from 1.5% at 5.0% HbA1c to 2.4% at 12.0% HbA1c. For hemolysate, the %TE ranged from 1.6% at 8.0% HbA1c to 2.1% at 6.5% HbA1c. All reported %TE values were significantly less than the ≤6% acceptance criterion. |
| Interference from Hemoglobin Variants: Performance testing must demonstrate that there is little to no interference from common hemoglobin variants, including Hemoglobin C, Hemoglobin D, Hemoglobin E, Hemoglobin A2, and Hemoglobin S. | Interference demonstrated: A study with 165 samples containing Hb variants (A2, C, D, E, F, S) showed that HbA1c results were accurate with no significant interference for HbA2 (≤16%), HbC (≤39%), HbD (≤36%), HbF (≤30%), HbS (≤40%). Bias results for HbA1c at ~6.5% and ~8.0% were generally within a low percentage range, indicating no significant interference. |
| Standardization Verification: Device must have initial and annual standardization verification by a certifying glycohemoglobin standardization organization deemed acceptable by the FDA. | Standardization verified: The HA-8180V HbA1c assay is NGSP certified, and certification is re-certified annually by ARKRAY. Traceability is established to the IFCC reference calibrators and the DCCT. |
2. Sample sizes used for the test set and data provenance
- Precision Study:
- Sample Size: 4 EDTA whole blood samples from different donors at approximate HbA1c concentrations of ~5.0%, ~6.5%, ~8.0%, and ~12.0%, and 3 quality control materials. Each sample was run in duplicate in two runs per instrument per day for 20 days across three instruments and three reagent lots.
- Data Provenance: The study was conducted at ARKRAY, USA, Edina, MN. It is a prospective study, as samples were "utilized in the study" and data "collected at ARKRAY."
- Method Comparison Study:
- Sample Size: 143 variant-free whole blood K2-EDTA samples.
- Data Provenance: The samples were collected from donors in an unspecified country (likely the US, given the study location in Minneapolis, MN) and were "variant-free." The study is likely prospective, involving the collection and testing of these specific samples.
- Hemoglobin Variant Study:
- Sample Size: 165 samples known to contain Hemoglobin variants A2, C, D, E, F, or S.
- Data Provenance: Not explicitly stated, but implies a collection of samples with known variants, likely from a clinical setting. It's a retrospective analysis of samples or prospective collection of specific variant samples.
3. Number of experts used to establish the ground truth for the test set and their qualifications
Ground truth for the test set was not established by human experts in a subjective manner as it is an in vitro diagnostic device for quantitative measurements.
- Precision Study: The ground truth was based on the device's own measurements of samples at known approximate HbA1c concentrations and quality control materials.
- Method Comparison Study: The ground truth (reference method) was established by a secondary NGSP reference laboratory using a previously cleared HPLC method (Tosoh G8), which is itself standardized and traceable.
- Hemoglobin Variant Study: The ground truth (reference method) was a method "that has been demonstrated to be free from the hemoglobin interference being tested." This implies an established and validated reference method for comparison, not expert consensus.
4. Adjudication method for the test set
Not applicable. This is a quantitative diagnostic device, and ground truth is established by reference methods or material characteristics, not subjective human assessment requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. This device is an automated in vitro diagnostic (IVD) system, not an imaging or interpretive device that typically involves human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies presented are standalone performance evaluations of the ADAMS A1c HA-8180V system. It is an automated analyzer, so its performance is inherently standalone (algorithm/instrument only) without human-in-the-loop performance affecting the results.
7. The type of ground truth used
- Precision Study: Intrinsic measurement from known samples and quality control materials.
- Method Comparison Study: The "gold standard" or reference method was the results from a secondary NGSP reference laboratory using a previously cleared HPLC method (Tosoh G8), which is traceable to IFCC and DCCT.
- Hemoglobin Variant Study: A "reference method that has been demonstrated to be free from the hemoglobin interference being tested."
- Linearity/Reportable Range: Theoretical values based on dilution factors of samples with known low and high HbA1c concentrations.
8. The sample size for the training set
This device does not utilize a "training set" in the context of machine learning. It is a chemical analyzer based on ion exchange HPLC technology. Its performance characteristics (precision, accuracy, linearity, interference) are evaluated directly through studies, rather than by training a model on data.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the machine learning sense for this type of IVD device.
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