Device class
Class II
Regulation 880.2806
Total clearances
3
2024-07-12 → 2026-06-18
Definition
What is Biological Sterilization Indicator With Indirect Growth Detection
A biological sterilization indicator with indirect growth detection capabilities is a device intended for use by a healthcare provider to accompany products being sterilized through a sterilization process to monitor the adequacy of sterilization. Detection of surviving microorganisms is accomplished by a method other than direct detection of growth or growth products.
Classification details
Medical specialty
General Hospital
Regulation number
880.2806
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 |
| 88079 |
CPT
|
— |
High
|
Biological indicator for sterilization validation, standard code for monitoring sterilization efficacy |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-06-18 |
K251559 |
True Indicating, LLC
|
InstaTRU Instant Biological Indicator for Steam (IBI-05) |
| 2026-04-22 |
K252306 |
Steritec Products
|
Verrix EVA STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA Auto-Reader (Model: 1100) |
| 2024-07-12 |
DEN220042 |
Terragene S.A.
|
Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH) |