Device class
Class II
Regulation 862.2570
Total clearances
3
2022-07-11 → 2025-03-20
Definition
What is Real Time Nucleic Acid Amplification System
The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system.
Classification details
Medical specialty
Clinical Chemistry
Regulation number
862.2570
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 |
| 87798 |
CPT
|
— |
High
|
Pathogen(s)-specific nucleic acid detection/amplification panel, respiratory pathogen(s), includes multiplex reverse transcription and multiplex amplified probe technique, multiple types or subtypes, real-time or end-point detection |
| 87501 |
CPT
|
— |
Medium
|
Influenza A or B, detection and differentiation by nucleic acid (DNA or RNA), real-time with report |
Pulse
Most recent 510(k) clearances