Cleared Traditional

VIDAS B.R.A.H.M.S. PCT ASSAY (K071146) - FDA 510(k) Clearance

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

K071146 · bioMerieux, Inc. · Microbiology device
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Oct 2007
Decision
170d
Days
Class 2
Risk

K071146 is an FDA 510(k) clearance for the VIDAS B.R.A.H.M.S. PCT ASSAY. Classified as Antigen, Inflammatory Response Marker, Sepsis (product code NTM), Class II - Special Controls.

Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on October 11, 2007 after a review of 170 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3210 - 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 bioMerieux, Inc. devices

Submission Details

510(k) Number K071146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2007
Decision Date October 11, 2007
Days to Decision 170 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 102d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NTM Antigen, Inflammatory Response Marker, Sepsis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3210
Definition An Immunoluminometric Assay Used To Determine The Concentration Of Procalcitonin (pct) In Human Serum And Plasma.
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.