| ISO 15197:2013 analytical accuracy | At least 95% of individual glucose results must be within ±15 mg/dL of the comparison value when glucose is below 100 mg/dL, or within ±15% when glucose is at least 100 mg/dL. | Independent verification confirms the stated ISO accuracy requirement across the claimed measuring range. | Complete accuracy study, test protocol, subject/sample distribution, comparison method, raw results, and statistical analysis. | Required |
| Consensus error-grid performance | At least 99% of results should fall within Zones A and B of the applicable consensus error grid when evaluated according to ISO 15197:2013. | Results meet the 99% Zone A+B criterion, with no clinically unacceptable concentration errors. | Error-grid plot, result-level dataset, zone calculation method, and independent laboratory review. | Required |
| Reference-method traceability | Comparison results should be traceable to a suitable laboratory reference measurement procedure with documented calibration and quality control. | The reference method, calibration chain, control materials, and measurement uncertainty are clearly documented. | Reference-laboratory certificate, method description, calibration records, control charts, and uncertainty statement. | Required |
| Measurement range | The displayed measuring range must be clearly stated in the instructions for use and on the product documentation. The range must not be inferred from marketing material. | The claimed range covers the intended patient population and is supported by validation data at low, mid-range, and high glucose concentrations. | Measuring-range validation report, low/high concentration results, product labeling, and out-of-range alert specifications. | Required |
| Hematocrit interference | Hematocrit can affect electrochemical glucose measurements. The meter must specify its validated hematocrit range and any limitations. | The validated hematocrit range matches the target market, and accuracy remains within the declared performance limits throughout that range. | Hematocrit interference study, tested glucose levels, statistical results, labeling limitations, and risk-control documentation. | Required |
| Interfering substances | Common potential interferents may include ascorbic acid, uric acid, acetaminophen, maltose, galactose, oxygen, and other substances relevant to the measurement technology. | Interference testing is completed for substances relevant to the chemistry, sample type, and intended use; clinically significant limitations are disclosed. | Interference study, concentration levels, acceptance limits, risk analysis, and updated instructions for use. | Required |
| Repeatability and precision | Repeated measurements under the same conditions should demonstrate consistent performance across multiple glucose concentrations. | Precision results meet the manufacturer’s predefined acceptance criteria and show no unexplained concentration-dependent bias. | Repeatability study, intermediate-precision study, lot information, operator variation, day-to-day variation, and control results. | Required |
| User self-testing performance | A system intended for home use should be evaluated with representative lay users, including sample application, coding or code-free operation, and result interpretation. | Representative users can complete the test correctly, and the design minimizes avoidable sampling, strip-insertion, and result-reading errors. | Usability engineering file, formative and summative study reports, error analysis, labeling validation, and user feedback. | Required |
| Sample volume and application | The required blood volume, sample type, under-fill detection, and re-dosing capability must be stated clearly and validated. | The required sample volume is practical for the target users, and insufficient or incorrectly applied samples generate a clear error message. | Product specification, under-fill study, sample-application validation, error-code list, and user instructions. | Required |
| Test-result timing | The time from correct sample application to displayed result should be measured under stated environmental and operating conditions. | The actual median and maximum test time are consistent with the product specification and user expectations. | Timing test report, operating-condition details, firmware version, and sample-to-result measurement method. | Required |
| Environmental operating conditions | Temperature, relative humidity, altitude, storage conditions, and transport limits must be defined because environmental factors can affect measurement performance. | Accuracy and function remain within specification throughout the declared operating and storage ranges. | Environmental validation, transport simulation, temperature/humidity testing, storage-life data, and packaging qualification. | Required |
| Strip lot-to-lot consistency | Different reagent-strip lots should provide consistent results when used with the same meter system. | Lot-to-lot bias is within the predefined acceptance limit, with documented release testing for each production lot. | Multiple-lot comparison study, lot-release specifications, certificates of analysis, and stability data. | Required |
| Connectivity and data integrity | Bluetooth or other wireless functions should transfer the correct result, unit, timestamp, and metadata without silent alteration or duplication. | Data transfer is accurate, traceable, and protected against unauthorized modification; the user can identify connection failures. | Connectivity validation, data-integrity test cases, cybersecurity risk assessment, interface specification, and failure-mode analysis. | Required for smart models |
| Units and localization | The device and application should support the glucose units required by each destination market, typically mg/dL or mmol/L, with safeguards against accidental unit changes. | Units are clearly displayed, configurable only through controlled settings, and correctly reflected in reports and exported data. | Localization matrix, unit-conversion verification, screen captures, software test report, and translated labeling. | Required |
| Regulatory and quality-system readiness | The supplier should maintain a documented medical-device quality system and provide market-specific technical documentation for the intended countries. | Quality-system certification, technical files, risk management, clinical or performance evidence, and post-market processes are available for review. | Quality certificate, declaration or registration documents, ISO 14971 risk file, design records, change-control procedure, and complaint process. | Required |
| Shelf life and packaging | Test strips and control materials require stability evidence covering labeled shelf life, opened-vial use period, and transport conditions. | The proposed shelf life is supported by real-time or scientifically justified stability data, with clear storage and discard instructions. | Stability protocol, accelerated and real-time data, packaging validation, moisture protection data, and expiration-label rationale. | Required |
| Pre-shipment quality inspection | Finished meters, strips, accessories, labels, manuals, and software versions should be checked before shipment. | Each shipment has documented sampling plans, functional checks, accuracy-control results, lot traceability, and release approval. | Inspection standard, sampling plan, batch records, calibration certificates, inspection report, and certificate of conformity. | Required |
