Cleared Traditional

AXINON® LDL-p Test System (K210801) - FDA 510(k) Clearance

Class I Chemistry device.

K210801 · Numares AG · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2023
Decision
854d
Days
Class 1
Risk

K210801 is an FDA 510(k) clearance for the AXINON® LDL-p Test System. Classified as System, Test, Low Density, Lipoprotein (product code MRR), Class I - General Controls.

Submitted by Numares AG (Regensburg, DE). The FDA issued a Cleared decision on July 19, 2023 after a review of 854 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - 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 Numares AG devices

Submission Details

510(k) Number K210801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2021
Decision Date July 19, 2023
Days to Decision 854 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
766d slower than avg
Panel avg: 88d · This submission: 854d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MRR System, Test, Low Density, Lipoprotein
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MRR System, Test, Low Density, Lipoprotein

All 9
Devices cleared under the same product code (MRR) and FDA review panel - the closest regulatory comparables to K210801.
Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)
K241800 · Siemens Healthcare Diagnostics, Inc. · Jul 2024
DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131
K020724 · Dade Behring, Inc. · May 2002
SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR
K014103 · Beckman Coulter, Inc. · Jan 2002
MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION
K012287 · Roche Diagnostics Corp. · Aug 2001
EZ LDL CHOLESTEROL TEST SYSTEM
K993741 · Sigma Diagnostics, Inc. · Jul 2000
COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT
K982848 · Roche Diagnostic Systems, Inc. · Oct 1998