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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 198
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K093794.
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K092906 · STERIS Corporation · Dec 2009
K093794 · SMART-READ EZTEST-STEAM SCBI AND TEST PACK
Download PDF FDA Summary Sgm Biotech, Inc.