Cleared Traditional

K122722 - COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190

Also marketed or referenced as:
PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160

K122722 is an FDA 510(k) clearance for COBAS C TINA-QUANT LIPOPROTEIN (A) GEN ..., manufactured by Roche Diagnostics. The device is a Class 2 Chemistry device with product code DFC cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K122722 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
85d
Days
Class 2
Risk

K122722 is an FDA 510(k) clearance for the COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190. Classified as Lipoprotein, Low-density, Antigen, Antiserum, Control (product code DFC), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on November 29, 2012 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diagnostics devices

FDA 510(k) Submission Details - K122722

510(k) Number K122722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2012
Decision Date November 29, 2012
Days to Decision 85 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
3d faster than avg
Panel avg: 88d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DFC Device Classification - Class 2, Special Controls

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 34
Devices cleared under the same product code (DFC) and FDA review panel - the closest regulatory comparables to K122722.
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
QUANTIA LA(A)
K050487 · Biokit, S.A. · Apr 2005
K-ASSAY LP(A) CONTROLS
K023853 · Kamiya Biomedical Co. · Dec 2002
K-ASSAY LP(A) ASSAY
K021660 · Kamiya Biomedical Co. · Jul 2002