Cleared Traditional

Urea Nitrogen2 (K203771) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203771 · Abbott Ireland Diagnostics Division · Chemistry device
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May 2022
Decision
524d
Days
Class 2
Risk

K203771 is an FDA 510(k) clearance for the Urea Nitrogen2. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Abbott Ireland Diagnostics Division (Longford, IE). The FDA issued a Cleared decision on May 31, 2022 after a review of 524 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1770 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Abbott Ireland Diagnostics Division devices

Submission Details

510(k) Number K203771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2020
Decision Date May 31, 2022
Days to Decision 524 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
436d slower than avg
Panel avg: 88d · This submission: 524d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1770
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 - CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen

All 39
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K203771.
BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER
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WAKO L-TYPE UN TEST
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SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P
K992800 · Sigma Diagnostics, Inc. · Sep 1999
SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT
K982236 · Sigma Diagnostics, Inc. · Aug 1998
UREA
K981918 · Abbott Laboratories · Jul 1998
IL TEST UREA NITROGEN
K974337 · Instrumentation Laboratory CO · Dec 1997