Cleared Traditional

K170652 - ARCHITECT B.R.A.H.M.S PCT

K170652 is the FDA 510(k) clearance for ARCHITECT B.R.A.H.M.S PCT by Fisher Diagnostics. It is a Class 2 Microbiology device (product code PRI) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K170652 · Fisher Diagnostics · Microbiology device
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Jun 2017
Decision
90d
Days
Class 2
Risk

K170652 is an FDA 510(k) clearance for the ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT .... Classified as Procalcitonin Assay (product code PRI), Class II - Special Controls.

Submitted by Fisher Diagnostics (Middletown, US). The FDA issued a Cleared decision on June 1, 2017 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K170652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2017
Decision Date June 01, 2017
Days to Decision 90 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
12d faster than avg
Panel avg: 102d · This submission: 90d
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.

Regulatory Peers - PRI Procalcitonin Assay

Devices cleared under the same product code (PRI) and FDA review panel - the closest regulatory comparables to K170652.
Elecsys BRAHMS PCT
K173927 · Roche Diagnostics · Jul 2018
LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers
K173683 · DiaSorin, Inc. · Feb 2018
Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set
K172713 · Fujirebio Diagnostics,Inc. · Dec 2017
VIDAS B.R.A.H.M.S. PCT (PCT)
K162827 · bioMerieux, Inc. · Feb 2017