Cleared Traditional

K181205 - Non-variola Orthopoxvirus Real-time PCR...

K181205 is an FDA 510(k) clearance for Non-variola Orthopoxvirus Real-time PCR..., manufactured by Centers For Disease Control and Prevention. The device is a Class 2 Microbiology device with product code PBK cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K181205 · Centers For Disease Control and Prevention · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2018
Decision
136d
Days
Class 2
Risk

K181205 is an FDA 510(k) clearance for the Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set. Classified as Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set (product code PBK), Class II - Special Controls.

Submitted by Centers For Disease Control and Prevention (Atlanta, US). The FDA issued a Cleared decision on September 20, 2018 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3315 - 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.

View all Centers For Disease Control and Prevention devices

FDA 510(k) Submission Details - K181205

510(k) Number K181205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2018
Decision Date September 20, 2018
Days to Decision 136 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
34d slower than avg
Panel avg: 102d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PBK Device Classification - Class 2, Special Controls

Product Code PBK Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3315
Definition In Vitro Qualitative Detection Of Non-variola Orthopoxvirus Nucleic Acids Extracted From Human Specimens Or Viral Culture.
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 - PBK Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set

Devices cleared under the same product code (PBK) and FDA review panel - the closest regulatory comparables to K181205.
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
K221834 · Centers For Disease Control and Prevention · Jun 2022
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
K221658 · Centers For Disease Control and Prevention · Jun 2022
NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET
DEN070001 · Centers For Disease Control and Prevention · Sep 2018