Device class
Class II
Regulation 862.3610
Total clearances
3
2020-07-31 → 2021-12-22
Classification details
Medical specialty
Clinical Toxicology
Regulation number
862.3610
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
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 |
| 80307 |
CPT
|
— |
High
|
Standard CPT for methamphetamine toxicology screening/confirmation |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2021-12-22 |
K203647 |
Immunalysis Corporation
|
SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay |
| 2021-12-15 |
K210212 |
Psychemedics Corporation
|
Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair |
| 2020-07-31 |
K201442 |
Diatron Group
|
Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers |