Cleared Traditional

K963841 - EZTEST

K963841 is an FDA 510(k) clearance for EZTEST, manufactured by Sgm Biotech, Inc.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K963841 · Sgm Biotech, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
153d
Days
Class 2
Risk

K963841 is an FDA 510(k) clearance for the EZTEST. 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 February 25, 1997 after a review of 153 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Sgm Biotech, Inc. devices

FDA 510(k) Submission Details - K963841

510(k) Number K963841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1996
Decision Date February 25, 1997
Days to Decision 153 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 129d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K963841.
BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320)
K972747 · Propper Mfg. Co., Inc. · Jan 1998
PROSPORE II
K971430 · Raven Biological Laboratories, Inc. · May 1997
PROSPORE
K971432 · Raven Biological Laboratories, Inc. · May 1997
STERITEC DISPOSABLE BIOLOGICAL TEST PACK
K961721 · Steritec Products Mfg Co, Inc. · Aug 1996
MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR
K960777 · Mdt Corp., Inc. · May 1996
ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X
K926364 · 3M Health Care, Ltd. · Mar 1995