Cleared Traditional

K171338 - B R A H M S PCT sensitive KRYPTOR (FDA 510(k) Clearance)

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

K171338 · Brahms GmbH · Microbiology device
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May 2017
Decision
23d
Days
Class 2
Risk

K171338 is an FDA 510(k) clearance for the B R A H M S PCT sensitive KRYPTOR. Classified as Procalcitonin Assay (product code PRI), Class II - Special Controls.

Submitted by Brahms GmbH (Henningsdorf, DE). The FDA issued a Cleared decision on May 31, 2017 after a review of 23 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.

View all Brahms GmbH devices

Submission Details

510(k) Number K171338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2017
Decision Date May 31, 2017
Days to Decision 23 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
79d faster than avg
Panel avg: 102d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PRI Procalcitonin Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3215
Definition To Aid In Decision Making On Antibiotic Therapy, Including Antibiotic Initiation And Discontinuation, For Inpatients Or Patients In The Emergency Department, With Suspected Or Confirmed Lower Respiratory Tract Infections (lrti) Defined As Community-acquired Pneumonia (cap), Acute Bronchitis, And Acute Exacerbation Of Chronic Obstructive Pulmonary Disease (aecopd).
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.