Cleared Traditional

JBAIDS Q FEVER DETECTION KIT (K103207) - FDA 510(k) Clearance

Class I Microbiology device.

K103207 · Idaho Technology, Inc. · Microbiology device
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May 2011
Decision
200d
Days
Class 1
Risk

K103207 is an FDA 510(k) clearance for the JBAIDS Q FEVER DETECTION KIT. Classified as Assay, Direct, Nucleic Acid Amplification, Q Fever (product code OVF), Class I - General Controls.

Submitted by Idaho Technology, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on May 20, 2011 after a review of 200 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3500 - 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 Idaho Technology, Inc. devices

Submission Details

510(k) Number K103207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2010
Decision Date May 20, 2011
Days to Decision 200 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
98d slower than avg
Panel avg: 102d · This submission: 200d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OVF Assay, Direct, Nucleic Acid Amplification, Q Fever
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3500
Definition These Reagents Are Nucleic Acid Primers And Probes Intended For The Amplification And Identification Of Coxiella Burnetii Directly From Clinical Specimens. The Identification Aids In The Diagnosis Of Q Fever And Provides Epidemiological Information On This Disease. This Reagent Differs From The Description In The Regulation In That It Consists Of Nucleic Acid Primers And Probes Rather Than Antisera Or Antigens.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.