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510(k) K252306

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) by Steritec Products — Product Code QVB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 22, 2026
Date Received: July 24, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Biological Sterilization Indicator With Indirect Growth Detection
Device Class: Class II
Regulation Number: 880.2806
Review Panel: HO
Submission Type

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.

Other clearances by Steritec Products

K083650 — EMU-GRAPH 4 EMULATOR, MODEL CI 144 (March 5, 2009)
K080136 — INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105 (August 15, 2008)
K052516 — STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, ST (October 3, 2005)
K040901 — STERITEC EMU-GRAPH, MODEL NO. CI 131/US (September 9, 2004)
K024293 — BOWIE-DICK MINI PAK, MODEL BD 115 (August 11, 2003)
K012732 — INTEGRAPH FLASH, MODEL CI 110 (March 4, 2002)
K010534 — CROSS-CHECKS DUAL, MODEL CI 125 (August 6, 2001)
K003533 — CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L (February 7, 2001)
K003002 — STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123 (December 8, 2000)
K002861 — EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124 (November 29, 2000)

510(k) K252306

Clearance Details

Device Classification

Other clearances by Steritec Products

Other clearances for product code QVB