Device class
Class II
Regulation 866.3378
Total clearances
4
2021-11-03 → 2023-08-31
Definition
What is Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
An automated in vitro diagnostic system to prepare colonies of microorganisms grown on solid culture media from human specimens for qualitative identification and differentiation using matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS).
Classification details
Medical specialty
Microbiology
Regulation number
866.3378
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 |
| 87152 |
CPT
|
— |
High
|
Chromogenic substrate-based enzyme immunoassay for detection; MALDI-TOF microbial identification |
| 87541 |
CPT
|
— |
High
|
Presumptive pathogenic organisms, identification by MALDI-TOF mass spectrometry |
Pulse
Most recent 510(k) clearances