Cleared Traditional

K052788 - N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H

K052788 is an FDA 510(k) clearance for N LATEX HCY, manufactured by Dade Behring, Inc.. The device is a Class 2 Chemistry device with product code LPS cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K052788 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
177d
Days
Class 2
Risk

K052788 is an FDA 510(k) clearance for the N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H. Classified as Urinary Homocystine (nonquantitative) Test System (product code LPS), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on March 29, 2006 after a review of 177 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1377 - 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 - K052788

510(k) Number K052788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2005
Decision Date March 29, 2006
Days to Decision 177 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
89d slower than avg
Panel avg: 88d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPS Device Classification - Class 2, Special Controls

Product Code LPS Urinary Homocystine (nonquantitative) Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1377
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 - LPS Urinary Homocystine (nonquantitative) Test System

All 24
Devices cleared under the same product code (LPS) and FDA review panel - the closest regulatory comparables to K052788.
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K032012 · Diazyme Laboratories · Sep 2003
ACS 180 HOMOCYSTEINE ASSAY
K013606 · Bayer Diagnostics Corp. · Dec 2001