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510(k) Data Aggregation
(182 days)
The APOLOWAKO HbA1c and APOLOWAKO Glucose are for the quantitative determination on the APOLOWAKO analyzer of hemoglobin A1c (HbA1c) % and glucose in whole blood samples.
HbA1c- Measurement of % HbA1c is used to monitor long-term glucose control in individuals with diabetes mellitus.
Glucose- Measurement of glucose is used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia and pancreatic islet cell carcinoma.
The APOLOWAKO analyzer is a fully-integrated POC test system that can perform up to six analytical tests per individual sample. For the HbA Ic test, whole blood, and not plasma, is used. For all other tests, the analyzer automatically separates plasma from whole blood for testing. Once the plasma has been separated, it is transferred to a cell on a measurement disk where the chemical reactions take place. The analyzer uses liquid reagents which are packaged into kits. Each kit contains 2 reagent units. Each unit is composed of two reagents and a calibrator. All of the reagents have a reagent information tag applied to the back of each bottle which controls the reagent parameters and conditions such as, calibration, reagent quantity, shelf-life, and lot number. The instrument contains an automated liquid dispenser, temperature controlled reagent carrousel, analysis compartment, and sample holder. The instrument is designed to automatically and constantly monitor the reagents, dispensing system, measurement disk, and measurement process to ensure that no erroneous results arc shown. The APOLOWAKO HbA1c and APOLOWAKO Glucose include hemoglobin A1c and glucose test reagents. The test system is designed for professional use and consists of a small table top instrument (31 cm wide x 47.5 cm high x 56 cm deep, weight: 25 kg).
The Wako Diagnostics APOLOWAKO HbA1c and APOLOWAKO Glucose test systems were evaluated for their ability to quantitatively determine hemoglobin A1c (HbA1c) % and glucose in whole blood samples.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate Device) | APOLOWAKO HbA1c Performance | APOLOWAKO Glucose Performance |
|---|---|---|---|
| Intended Use | Quantitative determination of HbA1c and glucose in whole blood for monitoring diabetes and diagnosing carbohydrate metabolism disorders. | Quantitative determination of HbA1c and glucose in whole blood samples for monitoring long-term glucose control in individuals with diabetes mellitus (HbA1c) and for diagnosis/treatment of carbohydrate metabolism disorders (Glucose). | Quantitative determination of HbA1c and glucose in whole blood samples for monitoring long-term glucose control in individuals with diabetes mellitus (HbA1c) and for diagnosis/treatment of carbohydrate metabolism disorders (Glucose). |
| Reportable Range | HbA1c: 4-15% Glucose: 50-500 mg/dL | HbA1c: 3-16.5% | Glucose: 18-350 mg/dL |
| Precision (Total Imprecision) | HbA1c: < 4% across 5.7%-9.4% (mean values) Glucose: < 6.5% across 103-127 mg/dL (mean values) | HbA1c: 3% or less across 4.8%-15.2% (mean values) | Glucose: Less than 2% CV across 72-540 mg/dL (mean values) |
| Linearity | Assay linear throughout reportable range | Assay linear throughout reportable range | Assay linear throughout reportable range |
| Interfering Substances | HbA1c: No interference from bilirubin, acetylsalicylic acid, caffeine, acetaminophen, hydroxyzine dihydroxychloride; elevated lipids may interfere. Glucose: Possible 6-7% difference between fingerstick and venous blood; 23 other substances had no effect. | No interference from high levels of bilirubin (conjugated and unconjugated), triglycerides, hemoglobin (for glucose only), sodium fluoride (glucose only), heparin sodium, EDTA-2Na, ascorbic acid, and others. Labile HbA1c, carbamylated hemoglobin, or acetylated hemoglobin has no influence on the HbA1c assay. | No interference from high levels of hemoglobin, bilirubin (conjugated or unconjugated), triglycerides, ascorbic acid, EDAT-2Na, heparin sodium, or sodium fluoride. |
Study that Proves Device Meets Acceptance Criteria:
The device's performance was evaluated through a combination of non-clinical and clinical studies.
2. Sample Size Used for the Test Set and Data Provenance
- HbA1c Test Set Sample Size: At least 352 samples.
- Glucose Test Set Sample Size: At least 387 samples.
- Data Provenance: Not explicitly stated, but the submission is from Wako Diagnostics, a US-based company, suggesting the studies were conducted to meet US regulatory requirements. The mention of "rigorous conditions sufficient to meet the requirements for CLIA Waiver" implies a focus on a US clinical laboratory context. The data is retrospective, derived from already collected samples used for method comparison.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for the test set was established by "FDA cleared comparison methods" and "reference method" as per the method comparison study, not by expert review of individual cases.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by comparison to reference methods, not by human expert adjudication of individual results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The evaluation focused on the accuracy of the device's measurements compared to predicate and reference methods, not on human reader performance with or without AI assistance.
6. Standalone Performance
Yes, a standalone performance study was done. The non-clinical evaluations (imprecision, linearity, interfering substances) and the method comparison study directly assess the algorithm's (device's) performance without human intervention in the result generation process. The device itself is described as an "analyzer" that performs "up to six analytical tests per individual sample" and "automatically and constantly monitor the reagents, dispensing system, measurement disk, and measurement
process to ensure that no erroneous results are shown," indicating standalone operation.
7. Type of Ground Truth Used
The ground truth used for the method comparison study was established by "FDA cleared comparison methods" and "reference method." This typically implies standardized laboratory assays or methods previously validated and cleared by regulatory bodies, representing the clinical standard for measuring HbA1c and glucose.
8. Sample Size for the Training Set
The document does not explicitly mention a separate "training set" or its size. In the context of in-vitro diagnostic devices like this one, development and internal validation (which might involve training if machine learning was used, though not explicitly stated for this 2008 device) would precede the reported verification and validation studies. The numbers provided (352 for HbA1c, 387 for glucose) are for the clinical method comparison study, which serves as a validation set.
9. How the Ground Truth for the Training Set Was Established
Since no explicit training set is mentioned, information on how its ground truth was established is not available in the provided text. For devices of this nature, ground truth for development and internal validation would typically be established using highly accurate laboratory reference methods or certified reference materials.
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