(623 days)
SD LipidoCare BT Home System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm; and to measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood from the fingertip. SD LipidoCare BT Home System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use).
The glucose testing system is for use by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. Glucose testing with the SD LipidoCare BT Home System should not be used for the diagnosis of or screening for diabetes and is not for use in neonates. For glucose testing, alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephoris, liver obstruction, other diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, and triglycerides.
SD LipidoCare BT Home Blood Glucose Test Strips are for use with SD LipidoCare BT Home Analyzer to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm by a single person and should not be shared. SD LipidoCare BT Home Lipid Profile Test Strips are intended for use with the SD LipidoCare BT Home Analyzer to quantitatively measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood by a single person and should not be shared.
SD LipidoCare BT Professional System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm; and to measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood from the fingertip. SD LipidoCare BT Professional System is intended to be used by lay-users and medical professionals. It is intended to be used by a single person and should not be shared. It is intended for testing outside the body (in vitro diagnostic use).
The glucose testing system is for people with diabetes as an aid to monitor the effectiveness of diabetes control. Glucose testing with the SD LipidoCare BT Professional System should not be used for the diagnosis of or screening for diabetes and is not for use in neonates. For glucose testing, alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephoris, liver obstruction, other diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, and triglycerides.
SD LipidoCare BT Professional Blood Glucose Test Strips are for use with SD LipidoCare BT Professional Analyzer to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm by lay users and medical professionals. SD LipidoCare BT Profile Test Strips are intended for use with the SD LipidoCare BT Professional Analyzer to be used to quantitatively measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood by lay users and medical professionals.
SD LipidoCare Home System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm; and to measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood from the fingertip. SD LipidoCare Home System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use).
The glucose testing system is for use by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. Glucose testing with the SD LipidoCare Home System should not be used for the diagnosis of or screening for diabetes and is not for use in neonates. For glucose testing, alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephoris, liver obstruction, other diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, and triglycerides.
SD LipidoCare Home Blood Glucose Test Strips are for use with SD LipidoCare Home Analyzer to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm by a single person and should not be shared. SD LipidoCare Home Lipid Profile Test Strips are intended for use with the SD LipidoCare Home Analyzer to quantitatively measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood by a single person and should not be shared.
SD LipidoCare Professional System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm; and to measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood from the fingertip. SD LipidoCare Professional System is intended to be used by lay-users and medical professionals. It is intended to be used by a single person and should not be shared. It is intended for testing outside the body (in vitro diagnostic use).
The glucose testing system is for people with diabetes as an aid to monitor the effectiveness of diabetes control. Glucose testing with the SD LipidoCare Professional System should not be used for the diagnosis of or screening for diabetes and is not for use in neonates. For glucose testing, alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatments with diabetes mellitus, nephoris, liver obstruction, other diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, and triglycerides.
SD LipidoCare Professional Blood Glucose Test Strips are for use with SD LipidoCare Professional Analyzer to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, or upper arm by lay users and medical professional Lipid Profile Test Strips are intended for use with the SD LipidoCare Professional Analyzer to be used to quantitatively measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood by lay users and medical professionals.
SD LipidoCare (BT) Professional/Home Analyzer can measure TC, TG, HDL, and Glucose, and it also can calculate LDL and non-HDL using the blood sample from the human with the SD LipidoCare (BT) Profiessional/Home Lipid Profile and SD LipidoCare (BT) Professional/Home Glucose test strips. This system is portable using batteries for power source and can store up to 500 test results in the memory. Users can search the stored results and can review the average results for 7, 15 and 30 day glucose test results. The average calculation function is for glucose test results only. This system can set the beep, date, time, unit, auto printing, simplex/duplex printing, hypo warning for glucose, alarms and Bluetooth. The analyzer offers 2 models: one with Bluetooth function for printing the test results and transferring data to a PC via Bluetooth technology and the other without it. The analyzer without the Bluetooth unit can still print the test results and transfer the data to a PC using a cable.
The system includes Lipid Profile Test Strip which is based on a reflectance photometry, and Glucose Test Strip which is based on glucose oxidase biosensor.
There are also lipid check strips and glucose check the internal malfunction (or problem) of the analyzer prior to testing.
The code chip is for the analyzer to read the lot-specific characteristics of the test strips currently in use. The SD Ezi Tube+ is used to apply blood sample for lipid profile testing.
Here's a breakdown of the acceptance criteria and the study information for the SD LipidoCare systems, based on the provided document:
The document combines information for four devices: SD LipidoCare Home System, SD LipidoCare Professional System, SD LipidoCare BT Home System, and SD LipidoCare BT Professional System. All four systems are intended for the quantitative measurement of glucose, total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood. The "BT" versions add Bluetooth functionality.
It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed clinical study report with explicit acceptance criteria for each performance metric. Therefore, some information, particularly around specific acceptance criteria values and the detailed methodology of how "ground truth" was established, is inferred or generalized from the context of substantial equivalence testing for IVD devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format for the subject devices (SD LipidoCare systems). Instead, it relies on demonstrating substantial equivalence to predicate devices. However, it does list the test ranges for both the predicate and new devices, which can be seen as the operational range where performance is expected to be acceptable. Performance is generally presented as "substantially equivalent" rather than with specific quantifiable metrics against a pre-defined criterion table.
Inferred Performance and Comparison:
| Attribute | Predicate: PTS PANELS Lipid Panel Test Strips | New Devices: SD LipidoCare (BT) Professional/Home (Lipid) | Predicate: SmartLink™ GOLD Blood Glucose Monitoring System | New Devices: SD LipidoCare (BT) Professional/Home (Glucose) |
|---|---|---|---|---|
| Test Range (Lipid) | ||||
| TC | 100-400 mg/dL (2.59-10.36 mmol/L) | 100-450 mg/dL (2.59-11.6 mmol/L) | N/A | N/A |
| TG | 50-500 mg/dL (0.57-5.65 mmol/L) | 45-650 mg/dL (0.51-7.43 mmol/L) | N/A | N/A |
| HDL | 15-100 mg/dL (0.57-2.59 mmol/L) | 25-95 mg/dL (0.65-2.46 mmol/L) | N/A | N/A |
| Hematocrit Range (Lipid) | ||||
| TC | 30-50% | 30-52% | N/A | N/A |
| TG | 15-55% | 30-52% | N/A | N/A |
| HDL | 30-45% | 30-52% | N/A | N/A |
| Test Range (Glucose) | N/A | N/A | 20-600 mg/dL (1.2-33.3 mmol/L) | IDENTICAL (20-600 mg/dL) |
| Hematocrit Range (Glucose) | N/A | N/A | 20-60% | IDENTICAL (20-60%) |
| Other Differences Not Quantified Against Criteria | ||||
| Test time (Lipid) | 1-2 minutes | 3 minutes | N/A | N/A |
| Operating Temp. (Lipid) | 20-27°C | 64-90°F (10-90% RH) | N/A | N/A |
| Memory (Lipid) | 300 tests | 500 tests | N/A | N/A |
| Operating Temp. (Glucose) | N/A | N/A | 10-45°C (50-113°F) | 64-90°F |
| Power Supply (Glucose) | CR 2032 Type | N/A | CR 2032 Type | Four 1.5V AA Alkaline batteries |
| Size (Glucose) | 4.7 x 9.5 x 1.75 (mm) | N/A | 4.7 x 9.5 x 1.75 (mm) | 6.72 x 13.3 x 2.85 (cm) |
Acceptance Criteria Implication: For many IVD devices, acceptance criteria often relate to accuracy (bias, precision), linearity, interference, and user performance. The document states that "We performed various clinical and bench tests and the test results supported that despite these differences the [subject device is] substantially equivalent to the predicate devices." This implies that the performance of the new devices, within their specified (and sometimes wider) ranges, met the accepted performance characteristics typically associated with the predicate devices, thereby not raising questions of safety and effectiveness.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the "clinical and bench tests" that demonstrated substantial equivalence.
Data Provenance: The manufacturer is SD Biosensor, Inc. from the Republic of Korea. The document does not explicitly state whether the data was retrospective or prospective, but clinical and bench testing for 510(k) submissions are typically prospective studies designed to evaluate the new device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish ground truth. For in vitro diagnostic (IVD) devices measuring biomarkers, ground truth is typically established using established laboratory reference methods performed by qualified laboratory personnel, rather than expert consensus on image interpretation.
4. Adjudication Method for the Test Set
The document does not mention an adjudication method. For quantitative measurements by IVD devices, adjudication (like 2+1 or 3+1 for imaging studies) is generally not applicable in the same way. The comparison is usually made directly against a 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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where AI assists human readers. The SD LipidoCare systems are in vitro diagnostic devices for quantitative measurement of blood analytes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone measurement system (analyzer and test strips). Its performance is inherently "standalone" in the sense that it provides a quantitative result without direct human interpretation of complex visual data or complex human-AI interaction. The "clinical and bench tests" would have evaluated this standalone performance.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For IVD devices measuring analytes like glucose, total cholesterol, triglycerides, and HDL cholesterol, the ground truth is typically established using reference laboratory methods (e.g., enzymatic colorimetric methods on a chemistry analyzer) operated by trained laboratory professionals. These methods are considered the gold standard for accurate quantitative measurements for these specific analytes in blood. The document implies this approach through its discussion of "Substantial Equivalence," which generally means the device's results correlate sufficiently with established laboratory methods.
8. The Sample Size for the Training Set
The document does not specify the sample size for a "training set." These devices typically do not involve AI algorithms that require explicit "training sets" in the conventional machine learning sense. Their performance is based on the chemical and enzymatic reactions within the test strips and the photometric/biosensor reading technology, which are validated through analytical and clinical studies.
9. How the Ground Truth for the Training Set Was Established
As noted above, a "training set" in the machine learning sense is not applicable here. The device's underlying principles (e.g., enzymatic reactions for glucose, photometric reading for lipids) are based on established scientific methods. Any calibration or internal adjustments made during manufacturing (which would be analogous to "training" in a very broad sense) would be done against reference standards, with the "ground truth" being the known concentrations of those reference standards.
§ 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.