Cleared Traditional

K013128 - N LATEX LP(A)

K013128 is an FDA 510(k) clearance for N LATEX LP(A), manufactured by Dade Behring, Inc.. The device is a Class 2 Chemistry device with product code DFC cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K013128 · Dade Behring, Inc. · Chemistry device
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Jan 2002
Decision
121d
Days
Class 2
Risk

K013128 is an FDA 510(k) clearance for the N LATEX LP(A). Classified as Lipoprotein, Low-density, Antigen, Antiserum, Control (product code DFC), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on January 18, 2002 after a review of 121 days - within the typical 510(k) review window.

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 Dade Behring, Inc. devices

FDA 510(k) Submission Details - K013128

510(k) Number K013128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2001
Decision Date January 18, 2002
Days to Decision 121 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
33d slower than avg
Panel avg: 88d · This submission: 121d
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 37
Devices cleared under the same product code (DFC) and FDA review panel - the closest regulatory comparables to K013128.
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K001929 · Wako Chemicals USA, Inc. · Jul 2000