Cleared Traditional

QUICKELISA ANTHRAX-PA KIT (K040407) - FDA 510(k) Clearance

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

K040407 · Immunetics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
107d
Days
Class 2
Risk

K040407 is an FDA 510(k) clearance for the QUICKELISA ANTHRAX-PA KIT. Classified as Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis (product code NRL), Class II - Special Controls.

Submitted by Immunetics, Inc. (Boston, US). The FDA issued a Cleared decision on June 3, 2004 after a review of 107 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Immunetics, Inc. devices

Submission Details

510(k) Number K040407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2004
Decision Date June 03, 2004
Days to Decision 107 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
5d slower than avg
Panel avg: 102d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NRL Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3045
Definition The Elisa Assay For Antibodies To B. Anthracis Is Used To Detect An Immunological Response To Proteins Secreted By B. Anthracis; As An Aid In The Laboratory Diagnosis Of Anthrax.
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.