Cleared Traditional

K030370 - REDLINE ANTHRAX ALERT TEST

K030370 is an FDA 510(k) clearance for REDLINE ANTHRAX ALERT TEST, manufactured by Tetracore, Inc.. The device is a Class 2 Microbiology device with product code NPO cleared through the Traditional 510(k) pathway after a 308-day FDA review.

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

FDA 510(k) Submission Details - K030370

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.

NPO Device Classification - Class 2, Special Controls

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.