Cleared Traditional

K241220 - Tina-quant Lipoprotein(a) Gen.2 Molarity

K241220 is the FDA 510(k) clearance for Tina-quant Lipoprotein(a) Gen.2 Molarity by Roche Diagnostics Operations. It is a Class 2 Chemistry device (product code DFC) cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K241220 · Roche Diagnostics Operations · Chemistry device
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Optimized for regulatory review, auditing and printing
Jan 2025
Decision
268d
Days
Class 2
Risk

K241220 is an FDA 510(k) clearance for the Tina-quant Lipoprotein(a) Gen.2 Molarity. Classified as Lipoprotein, Low-density, Antigen, Antiserum, Control (product code DFC), Class II - Special Controls.

Submitted by Roche Diagnostics Operations (Indianapolis, US). The FDA issued a Cleared decision on January 24, 2025 after a review of 268 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. 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 Roche Diagnostics Operations devices

Submission Details

510(k) Number K241220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2024
Decision Date January 24, 2025
Days to Decision 268 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
180d slower than avg
Panel avg: 88d · This submission: 268d
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.

Regulatory Peers - DFC Lipoprotein, Low-density, Antigen, Antiserum, Control

All 30
Devices cleared under the same product code (DFC) and FDA review panel - the closest regulatory comparables to K241220.
Lp(a) Ultra
K211058 · SENTINEL CH. SpA · Dec 2022
Diazyme Lipoprotein (a) Assay
K180074 · Diazyme Laboratories, Inc. · Mar 2018
ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR
K123046 · Siemens Healthcare Diagnostics, Inc. · Dec 2012
COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190
K122722 · Roche Diagnostics · Nov 2012
K-ASSAY LP(A) CONTROLS
K023853 · Kamiya Biomedical Co. · Dec 2002
K-ASSAY LP(A) ASSAY
K021660 · Kamiya Biomedical Co. · Jul 2002