(210 days)
The GLUCOLAB Auto-coding TM Diabetes Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings, including physician's office laboratories and point of care sites . The GLUCOLAB Auto-coding™ System provides plasma equivalent results. The GLUCOLAB Auto-coding 100 System is not intended to be used with neonatal blood samples. The GLUCOLAB Auto-coding 100 System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the forearm, upper arm, palm, calf and thigh.
GLUCOLAB Auto-coding™ control is used with GLUCOLAB Auto-coding™ Brand System to check that the meter and test strips are working together as a system and that you are performing the test correctly. It is very important that you do control solution tests routinely to make sure you are getting accurate results.
Control Solutions are sold separately.
GLUCOLAB Auto-coding 114 Blood Glucose Monitoring System is comprised of test meter, test strip and control solutions. GLUCOLAB Auto-coding™ Blood glucose test meter is substantially identical with the predicated device (GlucoLab™: K051285). The minor difference is that the GLUCOLAB Auto-coding™ test meter has auto-coding function, which GlucoLab ™ test meter does not have. GLUCOLAB Autocoding 1 test meter can recognize the code of the test strips automatically. This function is intended to decrease user's incorrect code matching.
GLUCOLAB Auto-coding™ blood glucose test strip is identical with the predicated device (GlucoLab™) K051285) except code recognition band at the back side of the strip. This code recognition band is for auto-coding function of GLUCOLAB Auto-coding™ test meter.
GLUCOLAB Auto-coding™ glucose control solutions are exactly same as GlucoLab™ control solutions.
The provided text describes the GLUCOLAB Auto-coding™ Blood Glucose Monitoring System and its 510(k) submission (K091157). However, it does not contain the detailed quantitative acceptance criteria or specific study results that would be necessary to fill out the requested table and answer many of the study-related questions.
The document states generally that:
- "The clinical performance evaluation using the GLUCOLAB Auto-coding™ Blood Glucose Monitoring System components were conducted for purpose of validating the consumer use for the user and the professional accuracy. Test results showed substantial equivalence."
- "Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the GLUCOLAB Auto-coding™ Blood Glucose Monitoring System. The device passed all of the tests based on pre-determined Pass/Fail criteria."
Without the actual performance data and acceptance criteria, much of the requested information cannot be provided.
Here's a breakdown of what can and cannot be answered from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Cannot be fully provided. The document states that "The device passed all of the tests based on pre-determined Pass/Fail criteria" for non-clinical tests and that "Test results showed substantial equivalence" for clinical tests. However, the specific quantitative pass/fail criteria (e.g., accuracy percentages, bias limits) and the detailed reported device performance (e.g., actual bias, accuracy within certain percentages) are not included in this summary.
| Acceptance Criteria (Quantitative) | Reported Device Performance (Quantitative) |
|---|---|
| Not provided in the text. | Not provided in the text. |
| (e.g., x% of results within ±y mg/dL or ±z%) | (e.g., 98% of results within ±15 mg/dL) |
| (e.g., Bias of no more than x%) | (e.g., Bias of -0.5%) |
2. Sample size used for the test set and the data provenance
- Sample size for the test set: Not specified in the provided text. The text only mentions "clinical performance evaluation" without detailing the number of participants or samples.
- Data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A (Not Applicable) for this type of device. For a blood glucose monitoring system, the "ground truth" for accuracy studies is typically established by comparing the device's readings against a laboratory reference method (e.g., a YSI analyzer) or a predicate device, not by expert consensus on diagnoses. The document mentions "professional accuracy" was evaluated.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A (Not Applicable) for this type of device. Adjudication is typically used in image-based or diagnostic interpretation studies where human expert consensus is needed to establish ground truth or resolve discrepancies. For a blood glucose monitor, the comparison is against an objective reference method.
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
N/A (Not Applicable). This is a blood glucose monitoring system, which is a standalone diagnostic device, not an AI-assisted interpretation tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes. The GLUCOLAB Auto-coding™ Blood Glucose Monitoring System is inherently a standalone device. Its "clinical performance evaluation" and "professional accuracy" assessment would be based on the device's direct measurement capabilities compared to a reference standard, without human interpretation as part of its primary function (other than user operation).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a blood glucose monitoring system, the ground truth is typically established by comparison to a laboratory reference method (e.g., a YSI Glucose Analyzer) or a legally marketed predicate device using plasma equivalent results. The text states: "The GLUCOLAB Auto-coding™ System provides plasma equivalent results." This implies comparison to a gold standard method for glucose measurement.
8. The sample size for the training set
N/A (Not Applicable). This device is not described as an AI/ML device that requires a "training set" in the traditional sense. It's a hardware-based measurement system. Unless there's an undisclosed AI component beyond the "auto-coding" function (which seems to be a simple recognition mechanism for test strips, not a learning algorithm), there would be no training set.
9. How the ground truth for the training set was established
N/A (Not Applicable). See point 8.
§ 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.