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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.

  1. Conduct comprehensive risk analysis to identify all potential sources of error
  2. Design and validate cleaning/disinfection procedures
  3. Perform complete performance evaluation studies (precision, linearity, method comparison)
  4. Conduct interference studies for all listed substances
  5. Validate device performance across claimed hematocrit range
  6. Develop comprehensive labeling including all required warnings and instructions
  7. Implement appropriate cybersecurity controls
  8. Establish test strip lot release criteria
  9. Validate device performance in intended use environment
  10. 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

  • 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
This post is licensed under CC BY 4.0 by the author.