Cleared Traditional

K211058 - Lp(a) Ultra (FDA 510(k) Clearance)

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

K211058 · SENTINEL CH. SpA · Chemistry device
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Dec 2022
Decision
622d
Days
Class 2
Risk

K211058 is an FDA 510(k) clearance for the Lp(a) Ultra. Classified as Lipoprotein, Low-density, Antigen, Antiserum, Control (product code DFC), Class II - Special Controls.

Submitted by SENTINEL CH. SpA (Milan, IT). The FDA issued a Cleared decision on December 22, 2022 after a review of 622 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5600 - 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 SENTINEL CH. SpA devices

Submission Details

510(k) Number K211058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2021
Decision Date December 22, 2022
Days to Decision 622 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
534d slower than avg
Panel avg: 88d · This submission: 622d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DFC Lipoprotein, Low-density, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5600
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.