Cleared Traditional

K231465 - Q-Pad Test System (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence.

K231465 · Qurasense · Chemistry device
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Optimized for regulatory review, auditing and printing
Dec 2023
Decision
201d
Days
Class 2
Risk

K231465 is an FDA 510(k) clearance for the Q-Pad Test System. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Qurasense (Menlo Park, US). The FDA issued a Cleared decision on December 6, 2023 after a review of 201 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7470 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Qurasense devices

Submission Details

510(k) Number K231465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2023
Decision Date December 06, 2023
Days to Decision 201 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 88d · This submission: 201d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCP Assay, Glycosylated Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7470
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Chemistry devices follow this clearance model.

Regulatory Consultant

Hyman, Phelps & McNamara, P.C.
Richard A. Lewis

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.