Cleared Special

K093794 - SMART-READ EZTEST-STEAM SCBI AND TEST PACK

K093794 is an FDA 510(k) clearance for SMART-READ EZTEST-STEAM SCBI AND TEST PACK, manufactured by Sgm Biotech, Inc.. The device is a Class 2 General Hospital device with product code FRC cleared through the Special 510(k) pathway after a 155-day FDA review.

K093794 · Sgm Biotech, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
155d
Days
Class 2
Risk

K093794 is an FDA 510(k) clearance for the SMART-READ EZTEST-STEAM SCBI AND TEST PACK. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Sgm Biotech, Inc. (Bozeman, US). The FDA issued a Cleared decision on May 14, 2010 after a review of 155 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sgm Biotech, Inc. devices

FDA 510(k) Submission Details - K093794

510(k) Number K093794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2009
Decision Date May 14, 2010
Days to Decision 155 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 129d · This submission: 155d
Pathway characteristics
Modification to existing cleared device.

FRC Device Classification - Class 2, Special Controls

Product Code FRC Indicator, Biological Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FRC Indicator, Biological Sterilization Process

All 154
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K093794.
STERRAD CYCLESURE BIOLOGICAL INDICATOR
K103222 · Advanced Sterilization Products · Feb 2011
STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR
K102884 · Advanced Sterilization Products · Jan 2011
3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTEST RAPID READOUT STEAM-PLUS
K101910 · 3M Company · Dec 2010
VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION
K092906 · STERIS Corporation · Dec 2009
VERIFY SCBI 275F 3-10
K083665 · STERIS Corporation · Sep 2009
MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 1292
K090569 · 3M Company · Apr 2009