Cleared Traditional

K163646 - Terragene Bionova SCBI (BT220

K163646 is an FDA 510(k) clearance for Terragene Bionova SCBI (BT220, manufactured by Terragene S.A.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K163646 · Terragene S.A. · General Hospital
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Nov 2017
Decision
314d
Days
Class 2
Risk

K163646 is an FDA 510(k) clearance for the Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R).... Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Terragene S.A. (Rosario, AR). The FDA issued a Cleared decision on November 2, 2017 after a review of 314 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 Terragene S.A. devices

FDA 510(k) Submission Details - K163646

510(k) Number K163646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2016
Decision Date November 02, 2017
Days to Decision 314 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
185d slower than avg
Panel avg: 129d · This submission: 314d
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 128
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