Cleared Traditional

K231465 - Q-Pad Test System

K231465 is an FDA 510(k) clearance for Q-Pad Test System, manufactured by Qurasense. The device is a Class 2 Chemistry device with product code LCP cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K231465 · Qurasense · Chemistry device
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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

FDA 510(k) Submission Details - K231465

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.

LCP Device Classification - Class 2, Special Controls

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.

Regulatory Peers - LCP Assay, Glycosylated Hemoglobin

All 154
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K231465.
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