Veridian Corp
Veridian Glucose Patch (VGP-200)
510(k) Number: K231156
Wearable continuous glucose monitoring patch for diabetes management in adults with Type 1 and Type 2 diabetes.
510(k) Clearance Summary
| Field | Value |
|---|---|
| Device Name | Veridian Glucose Patch, Model VGP-200 |
| 510(k) Number | K231156 |
| Decision Date | September 22, 2023 |
| Product Code | NBW — Glucose monitor, invasive, continuous |
| Regulation Number | 21 CFR 862.1355 |
| Predicate Device | GlucoSense Pro Patch (510(k) K201234) |
| Review Panel | Clinical Chemistry |
| Wear Duration (cleared) | 14 days per patch |
The Veridian Glucose Patch VGP-200 is indicated for continuous glucose monitoring in adults 18 years and older with diabetes mellitus.
Glucose readings from the VGP-200 must not be used as the sole basis for insulin dosing without confirmatory fingerstick testing during the first 48 hours of wear.
Patient health data collected by the VGP-200 is classified as PHI and must be handled per the Veridian Data Handling SOP and HIPAA Security Rule.
Mobile app companion software (VGP-App v3.1) is validated as an accessory device per 510(k) K231156-A.
Clinical Performance Data
| Metric | Result | Reference Standard | Acceptance |
|---|---|---|---|
| Mean Absolute Relative Difference (MARD) | 8.7% | YSI 2300 Stat Plus | ≤ 10% |
| Clarke Error Grid Zone A | 94.2% | Reference glucose | ≥ 90% |
| Hypoglycemia Detection (≤70 mg/dL) | Sensitivity 92.1% | Reference glucose | ≥ 85% |
| Hyperglycemia Detection (≥250 mg/dL) | Sensitivity 96.4% | Reference glucose | ≥ 90% |
| Sensor Warm-up Time | 45 minutes | Design spec | ≤ 60 minutes |
Full clinical protocol: VRD-CT-2024-001 (PDF) · Clinical Trials Registry
Data Privacy & HIPAA Requirements
Glucose data transmitted from the VGP-200 to Veridian cloud servers must be encrypted using TLS 1.3 and stored with AES-256 encryption at rest.
Patients must provide explicit HIPAA authorization before glucose data is shared with healthcare providers through the Veridian Care Portal.
Glucose trend data retained for research purposes must be de-identified per HIPAA Safe Harbor method before use.