Blood Glucose Monitoring Systems for Prescription Point-of-Care Use - Performance Standards and Technical Requirements
This guidance addresses Blood Glucose Monitoring Systems (BGMSs) regulated under 21 CFR 862.1345 for prescription point-of-care use. It specifically covers devices with product codes CGA (glucose oxidase method), CFR (hexokinase method), and LFR (glucose dehydrogenase method). The guidance excludes self-monitoring blood glucose devices for home use, diabetes screening/diagnostic devices, continuous glucose monitors, non-invasive glucose devices, and specialized blood glucose technologies.
Recommended Actions
- Conduct comprehensive risk analysis to identify all potential sources of error
- Design and validate cleaning/disinfection procedures
- Perform complete performance evaluation studies (precision, linearity, method comparison)
- Conduct interference studies for all listed substances
- Validate device performance across claimed hematocrit range
- Develop comprehensive labeling including all required warnings and instructions
- Implement appropriate cybersecurity controls
- Establish test strip lot release criteria
- Validate device performance in intended use environment
- Consider submitting dual 510(k)/CLIA waiver application if seeking CLIA waived status
Key Considerations
Clinical testing
- Minimum 350 patients for each claimed sample type (arterial, venous, capillary)
- Must include at least 50 patients from each defined vulnerable subpopulation
- For neonatal use: 100-150 fresh neonatal blood specimens required
- 95% of values must be within ±12% of comparator method for glucose >75 mg/dL
- 98% of values must be within ±15% of comparator method for glucose >75 mg/dL
Non-clinical testing
- Precision evaluation using venous blood samples across 5 glucose concentration ranges
- Linearity evaluation across entire measuring range using at least 11 concentrations
- Interference testing for endogenous/exogenous substances at clinically relevant concentrations
- Hematocrit testing across 10-65% range in 5% intervals
- Stability testing for both closed and open vial claims
Human Factors
- Studies must be conducted with intended point-of-care operators
- Minimum 9 operators should participate in each sample type study
- Testing should reflect actual use conditions and environment
Software
- Considered moderate level of concern devices
- Must include cybersecurity controls and documentation
- Software description should follow FDA’s guidance for software in medical devices
Cybersecurity
- Must develop and implement appropriate cybersecurity controls
- Should maintain device functionality and safety
- Follow FDA guidance on pre-market and post-market cybersecurity management
Labeling
- Must include cleaning and disinfection procedures
- Clear warnings about bloodborne pathogen transmission risks
- Instructions for specimen collection and preparation
- Performance characteristics and limitations
- Error messages and troubleshooting procedures
- Storage instructions and quality control procedures
Safety
- Must include validated cleaning and disinfection procedures
- Design should minimize risk of bloodborne pathogen transmission
- Only auto-disabling, single-use lancing devices permitted
- Must demonstrate robustness to cleaning/disinfection procedures
Other considerations
- Test strip lot release criteria must ensure consistent quality
- Third-party test strip manufacturers must address meter compatibility
- System must detect used test strips and prevent results
- Environmental conditions testing required (temperature, humidity, altitude)
Relevant Guidances
- Human Factors Information Needed in Medical Device Marketing Submissions (Draft)
- Content of Premarket Submissions for Device Software Functions
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Design Considerations for Medical Devices Intended for Home Use
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
Related references and norms
- ASTM E1053-11: Standard Test Method for Efficacy of Virucidal Agents Intended for Inanimate Environmental Surfaces
- ASTM E2362-09: Standard Practice for Evaluation of Pre-saturated or Impregnated Towelettes for Hard Surface Disinfection
- CLSI EP6-A: Evaluation of the Linearity of Quantitative Measurement Procedures
- CLSI EP-18A2: Risk Management Techniques to Identify and Control Laboratory Error Sources
- ISO 14971: Medical devices – Application of risk management to medical devices
Original guidance
- Blood Glucose Monitoring Systems for Prescription Point-of-Care Use - Performance Standards and Technical Requirements
- HTML / PDF
- Issue date: 2020-09-29
- Last changed date: 2021-01-26
- Status: FINAL
- Official FDA topics: Medical Devices, Premarket, IVDs (In Vitro Diagnostic Devices), General Hospital & Personal Use, Clinical Chemistry & Clinical Toxicology, CLIA (Clinical Laboratory Improvement Amendments)
- ReguVirta summary file ID: 5beec6fef8b99ec826235a78220b3675
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