Cleared Traditional

K212193 - Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) (FDA 510(k) Clearance)

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

K212193 · Plasmapp Co,., Ltd. · General Hospital

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Optimized for regulatory review, auditing and printing

Oct 2021

Decision

100d

Days

Class 2

Risk

K212193 is an FDA 510(k) clearance for the Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FR.... Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Plasmapp Co,., Ltd. (Daejeon, KR). The FDA issued a Cleared decision on October 22, 2021 after a review of 100 days - within the typical 510(k) review window.

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 Plasmapp Co,., Ltd. devices

Submission Details

510(k) Number	K212193 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 14, 2021
Decision Date	October 22, 2021
Days to Decision	100 days
Submission Type	Traditional
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

28d faster than avg

Panel avg: 128d · This submission: 100d

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.

Regulatory Consultant

CardioMed Device Consultants, LLC

Candace Cederman

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.