Cleared Traditional

K160729 - Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5

K160729 is an FDA 510(k) clearance for Elecys BRAHMS PCT, manufactured by Roche Diagnostics. The device is a Class 2 Microbiology device with product code PMT cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K160729 · Roche Diagnostics · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K160729

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
Combination Product No
PCCP Authorized No
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.

PMT Device Classification - Class 2, Special Controls

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.

Regulatory Peers - PMT Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens

Devices cleared under the same product code (PMT) and FDA review panel - the closest regulatory comparables to K160729.
VITROS BRAHMS PCT Reagent Pack and Calibrators
K200236 · Ortho-Clinical Diagnostics · Feb 2020
Atellica IM BRAHMS Procalcitonin (PCT)
K181002 · Siemens Healthcare Diagnostics, Inc. · Jul 2018
VIDAS B.R.A.H.M.S. PCT (PCT)
K160911 · bioMerieux, Inc. · Jun 2016
B.R.A.H.M.S PCT sensitive KRYPTOR
DEN150009 · Brahms GmbH · Feb 2016
K160729 · Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5
Download PDF FDA Summary Roche Diagnostics