Cleared Traditional

K133382 - QB TEST

K133382 · Qbtech AB · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
140d
Days
-
Risk

K133382 is an FDA 510(k) clearance for the QB TEST. Classified as Recorder, Attention Task Performance (product code LQD).

Submitted by Qbtech AB (Stockholm, SE). The FDA issued a Cleared decision on March 24, 2014 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel. 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K133382

510(k) Number K133382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2013
Decision Date March 24, 2014
Days to Decision 140 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 149d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

LQD Device Classification - Class 0,

Product Code LQD Recorder, Attention Task Performance
Device Class -

Regulatory Peers - LQD Recorder, Attention Task Performance

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K133382 · QB TEST
Download PDF FDA Summary Qbtech AB