Cleared Traditional

B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM (K070310) - FDA 510(k) Clearance

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

K070310 · Brahms Aktiengesellschaft · Microbiology device
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Mar 2008
Decision
424d
Days
Class 2
Risk

K070310 is an FDA 510(k) clearance for the B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM. Classified as Antigen, Inflammatory Response Marker, Sepsis (product code NTM), Class II - Special Controls.

Submitted by Brahms Aktiengesellschaft (Annapolis, US). The FDA issued a Cleared decision on March 31, 2008 after a review of 424 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

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Submission Details

510(k) Number K070310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2007
Decision Date March 31, 2008
Days to Decision 424 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
322d slower than avg
Panel avg: 102d · This submission: 424d
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.