Cleared Dual Track

K180509 - Quo-Test A1c System

K180509 is an FDA 510(k) clearance for Quo-Test A1c System, manufactured by Ekf Diagnostic GmbH. The device is a Class 2 Chemistry device with product code LCP cleared through the Dual Track 510(k) pathway after a 354-day FDA review.

K180509 · Ekf Diagnostic GmbH · Chemistry device
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Feb 2019
Decision
354d
Days
Class 2
Risk

K180509 is an FDA 510(k) clearance for the Quo-Test A1c System. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Ekf Diagnostic GmbH (Barleben, DE). The FDA issued a Cleared decision on February 16, 2019 after a review of 354 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Ekf Diagnostic GmbH devices

FDA 510(k) Submission Details - K180509

510(k) Number K180509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2018
Decision Date February 16, 2019
Days to Decision 354 days
Submission Type Dual Track
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
266d slower than avg
Panel avg: 88d · This submission: 354d
Pathway characteristics

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - LCP Assay, Glycosylated Hemoglobin

All 186
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K180509.
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K173127 · Skyla Corporation H.S.P.B · Sep 2018
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