Cleared Traditional

K031114 - PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA

K031114 is an FDA 510(k) clearance for PRO-PACT PERACETIC ACID CULTURE TEST KIT, manufactured by Raven Biological Laboratories, Inc.. The device is a Class 2 General Hospital device with product code MRB cleared through the Traditional 510(k) pathway after a 330-day FDA review.

K031114 · Raven Biological Laboratories, Inc. · General Hospital
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Mar 2004
Decision
330d
Days
Class 2
Risk

K031114 is an FDA 510(k) clearance for the PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA. Classified as Indicator, Biological, Liquid Chemical Sterilization Process (product code MRB), Class II - Special Controls.

Submitted by Raven Biological Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on March 3, 2004 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Raven Biological Laboratories, Inc. devices

FDA 510(k) Submission Details - K031114

510(k) Number K031114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2003
Decision Date March 03, 2004
Days to Decision 330 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
201d slower than avg
Panel avg: 129d · This submission: 330d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRB Device Classification - Class 2, Special Controls

Product Code MRB Indicator, Biological, Liquid Chemical 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.