Cleared Traditional

K210793 - VIDAS NEPHROCHECK (FDA 510(k) Clearance)

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

K210793 · Biom?rieux SA · Chemistry device
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Jul 2022
Decision
479d
Days
Class 2
Risk

K210793 is an FDA 510(k) clearance for the VIDAS NEPHROCHECK. Classified as Acute Kidney Injury Test System (product code PIG), Class II - Special Controls.

Submitted by Biom?rieux SA (Marcy L'Etoile, FR). The FDA issued a Cleared decision on July 8, 2022 after a review of 479 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1220 - 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.

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Submission Details

510(k) Number K210793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2021
Decision Date July 08, 2022
Days to Decision 479 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
391d slower than avg
Panel avg: 88d · This submission: 479d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PIG Acute Kidney Injury Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1220
Definition An Acute Kidney Injury Test System Is Intended To Measure One Or More Analytes In Human Samples As An Aid In The Assessment Of A Patient's Risk For Developing Acute Kidney Injury. Test Results Are Intended To Be Used In Conjunction With Other Clinical And Diagnostic Findings, Consistent With Professional Standards Of Practice, Including Conifmration By Alternative Methods.
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.