Cleared Traditional

K160729 - Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 (FDA 510(k) Clearance)

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

K160729 · Roche Diagnostics · Microbiology device
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Optimized for regulatory review, auditing and printing
Jun 2016
Decision
89d
Days
Class 2
Risk

K160729 is an FDA 510(k) clearance for the Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5. Classified as Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens (product code PMT), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on June 13, 2016 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3215 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K160729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2016
Decision Date June 13, 2016
Days to Decision 89 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
13d faster than avg
Panel avg: 102d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PMT Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3215
Definition An Assay Used To Determine The Level Of Procalcitonin (pct) In Human Serum And Plasma As An Aid In Assessing The Mortality For Patients Diagnosed With Severe Sepsis Or Septic Shock.
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.