Device class
Class II
Regulation 862.1345
Total clearances
5
2022-05-23 → 2026-06-12
Definition
What is Prescription Use Blood Glucose Meter For Near-Patient Testing
Intended for use in near-patient testing settings for in vitro diagnostic, multiple-patient use for the quantitative determination of glucose throughout all hospital and all professional healthcare settings for use in determining dysglycemia.
Classification details
Medical specialty
Clinical Chemistry
Regulation number
862.1345
Trend
Clearance volume by quarter
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Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 82962 |
CPT
|
— |
High
|
Glucose quantitative measurement by photometry, standard blood glucose meter code |
| 99002 |
CPT
|
— |
Medium
|
Unlisted laboratory procedure if near-patient testing in specific setting requires separate billing |
Pulse
Most recent 510(k) clearances