Not Cleared Direct

DEN150009 - B.R.A.H.M.S PCT sensitive KRYPTOR (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN150009 · Brahms GmbH · Microbiology device
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Feb 2016
Decision
353d
Days
Class 2
Risk

DEN150009 is an FDA 510(k) submission (not cleared) for the B.R.A.H.M.S PCT sensitive KRYPTOR. Classified as Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens (product code PMT), Class II - Special Controls.

Submitted by Brahms GmbH (Henningsdorf, DE). The FDA issued a Not Cleared (DENG) decision on February 20, 2016 after a review of 353 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 353 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

510(k) Number DEN150009 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 04, 2015
Decision Date February 20, 2016
Days to Decision 353 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
251d slower than avg
Panel avg: 102d · This submission: 353d
Pathway characteristics

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.