Cleared Traditional

K170940 - Rickettsia Real-time PCR Assay (FDA 510(k) Clearance)

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

K170940 · Centers For Disease Control and Prevention (Cdc) · Microbiology device
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Jun 2017
Decision
91d
Days
Class 2
Risk

K170940 is an FDA 510(k) clearance for the Rickettsia Real-time PCR Assay. Classified as Rickettsia Spp. Nucleic Acid Based Detection Assay (product code PVQ), Class II - Special Controls.

Submitted by Centers For Disease Control and Prevention (Cdc) (Atlanta, US). The FDA issued a Cleared decision on June 29, 2017 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3316 - 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 (Cdc) devices

Submission Details

510(k) Number K170940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2017
Decision Date June 29, 2017
Days to Decision 91 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
11d faster than avg
Panel avg: 102d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PVQ Rickettsia Spp. Nucleic Acid Based Detection Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3316
Definition An In Vitro Diagnostic Test For The Detection Of Rickettsia Spp. Nucleic Acids In Specimens From Individuals With Signs Or Symptoms Of Rickettsial Infection And Epidemiological Risk Factors Consistent With Potential Exposure. Test Results Are Used In Conjunction With Other Diagnostic Assays And Clinical Observations To Aid In The Diagnosis Infection, In Accordance With Criteria Defined By The Appropriate Public Health Authorities In The Federal Government.
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.