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510(k) Data Aggregation
(788 days)
The Assure Titanium Blood Glucose Monitoring System consists of the Assure Titanium Blood Glucose meter and the Assure Titanium Blood Glucose test strips. The Assure Titanium Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The system is intended for in vitro diagnostic, point of care use in endocrinology clinics and nursing facilities, for multiple patient use. This system should only be use, auto-disabling lancing devices for drawing finger stick capillary blood.
The system is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.
The system is not intended for use in acute care or hospital settings.
The system is not intended for neonatal use.
The system is for prescription use only.
The Assure Titanium Blood Glucose Monitoring System consists of a battery-powered meter, disposable test strips Assure Titanium Blood Glucose Test Strips, and control solutions. The Assure Titanium Blood Glucose Test Strips utilizes biosensor technology for the quantitative determination of glucose concentrations in capillary blood samples. Glucose in the blood reacts with the reagent in the test strip, and this produces a small electric current (amperometry). The strength of this current is proportional to the concentration of glucose in the blood. The meter measures this current and calculates the patient's glucose level.
The Assure® Titanium Blood Glucose Monitoring System underwent extensive performance testing to demonstrate its safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision | Within-run Precision: %CV ≤ 4.2% | Within-run Precision: Met %CV ≤ 4.2% across all glucose levels (30-400 mg/dL) and all three test strip lots. For example, for Lot 280-2, %CV ranged from 2.1% to 3.1%. For Lot 280-4, %CV ranged from 1.9% to 2.9%. For Lot 280-5, %CV ranged from 2.3% to 2.7%. |
| Intermediate Precision: Not explicitly stated with a numerical criterion in the document for all levels, but the document states "Intermediate precision met the overall acceptance criteria." | Intermediate Precision: All Lots Combined results showed %CV ranging from 1.4% to 2.1% across glucose levels from 30-400 mg/dL. | |
| Linearity | All measurements to fall within ±15% at 600 mg/dL. | Error Codes for Samples Outside Measuring Range: All results met the acceptance criteria, displaying "Lo" for 600 mg/dL. |
| Error Codes and Flagging | For each error code/flag, the appropriate conditions must trigger it, and conditions that should not trigger it must not. | Error Codes and Flagging: For each error code/flag listed (E-1 to E-10, E6, E5, E0, Control Solution Flag, Temperature Flag), the appropriate conditions triggered the error, and non-triggering conditions did not, verifying proper functionality. |
| Short Sample Detection | The system should either produce an error or an accurate result when a short sample is applied. | Short Sample Detection: The system demonstrated it will either produce an error or an accurate result when short sampled (using sample volumes from 0.1 to 10 uL). |
| Sample Perturbation | The system should either provide an error or an accurate result when the sample is perturbed. | Sample Perturbation: The system demonstrated it would either provide an error or an accurate result when the sample was perturbed (by flicking the test strip, flipping the meter, or wicking the sample away). |
| Testing with Used Test Strip | All used test strips shall produce the E1 error upon re-insertion, and no glucose measurement results should be provided. | Testing with Used Test Strip: All test results met the acceptance criteria, producing the E1 error upon re-insertion of used test strips. |
| Clinical Accuracy (Method Comparison) | Nursing/Skilled Nursing Facility: 300 mg/dL:** 100% within ±20%. | Accuracy at Extremes: 300 mg/dL: 100% (50/50) within ±12%, ±15%, and ±20% (92% within ±10%, 64% within ±5%). |
| Usability | Positive feedback on ease of use and understanding of the system and manuals. | Usability: 100% of POC operators provided positive feedback (Very Easy, or OK) on the ease of use of the blood glucose meter system and the user manual/quick reference guide. |
2. Sample Size Used for the Test Set and the Data Provenance:
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Precision (Within-run): 1500 tests (500 results on each of 3 lots)
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Precision (Intermediate): 1500 tests (50 tests per lot per day over 10 days for 3 lots)
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Linearity: 165 results (5 replicates per level for 11 glucose concentrations, across 3 test strip lots)
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Clinical Accuracy (Method Comparison): Capillary blood samples from 396 patients were measured.
- Site #1 (Nursing/Skilled Nursing Facility): 130 patients
- Site #2 (Endocrinology Clinic, California): 165 patients
- Site #3 (Endocrinology Clinic, Georgia): 101 patients
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Accuracy at Extremes: 100 samples (50 samples 300 mg/dL).
The provenance for precision, linearity, hematocrit, and interference studies appears to be laboratory-controlled (venous whole blood spiked or glycolyzed). The clinical study data provenance is prospective, collected in the United States (Massachusetts, California, Georgia) at one nursing/skilled nursing facility and two endocrinology clinics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
The document mentions that the YSI Model 2300 Glucose Analyzer was used as the reference standard (comparator method) for establishing ground truth in the linearity, clinical accuracy, and accuracy at extremes studies. The YSI 2300 is a laboratory instrument, not a human expert. Therefore, no human experts were used to establish the ground truth for these quantitative measurements.
For the usability study, "POC operators" were involved in evaluating the system, but they weren't establishing a "ground truth" for glucose levels. Their qualifications are not specified beyond being "Point-of-Care operators."
4. Adjudication Method for the Test Set:
Not applicable, as the ground truth for glucose measurements was established by a laboratory reference instrument (YSI 2300), not through expert consensus 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 a Blood Glucose Monitoring System, and its performance is evaluated by comparing its readings directly to a laboratory reference standard (YSI 2300), not by assessing how human readers improve with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the core performance studies (precision, linearity, hematocrit, interference, environmental, altitude, error codes, short sample detection, sample perturbation, used test strip detection) evaluate the standalone performance of the Assure® Titanium Blood Glucose Monitoring System (meter and test strips) by comparing its output directly to a reference method or evaluating built-in error detection mechanisms.
The clinical accuracy study also compares the device's measurements (obtained by POC operators, but the measurement itself is algorithmic) against the YSI 2300 reference, effectively demonstrating its standalone accuracy in a clinical setting.
7. The Type of Ground Truth Used:
The primary ground truth used for quantitative glucose measurements was reference laboratory method data, specifically from the YSI Model 2300 Glucose Analyzer.
8. The Sample Size for the Training Set:
The document does not specify a separate "training set" or its size. This is typical for a medical device cleared via a 510(k) pathway, especially for a blood glucose monitoring system, where development often involves calibration and verification/validation against reference methods rather than supervised machine learning model training.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as a separate training set and its ground truth establishment are not discussed in the provided submission. The device's underlying principles (electrochemical biosensor) are well-established, and its "training" or calibration would typically be an inherent part of its manufacturing process, verified through performance testing against reference standards as described.
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