Cleared Traditional

REDLINE ANTHRAX ALERT TEST (K030370) - FDA 510(k) Clearance

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

K030370 · Tetracore, Inc. · Microbiology device
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Dec 2003
Decision
308d
Days
Class 2
Risk

K030370 is an FDA 510(k) clearance for the REDLINE ANTHRAX ALERT TEST. Classified as Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody (product code NPO), Class II - Special Controls.

Submitted by Tetracore, Inc. (Gaithersburg,, US). The FDA issued a Cleared decision on December 9, 2003 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3045 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Tetracore, Inc. devices

Submission Details

510(k) Number K030370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2003
Decision Date December 09, 2003
Days to Decision 308 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
206d slower than avg
Panel avg: 102d · This submission: 308d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NPO Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3045
Definition A Serological Reagent To Distinguish B. Anthracis Culture Growth From Other Bacillus Spp. Growth
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 Microbiology devices follow this clearance model.