Cleared Traditional

K163646 - Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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

186d slower than avg

Panel avg: 128d · This submission: 314d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

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.