Cleared Traditional

K123930 - VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT

K123930 is the FDA 510(k) clearance for VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT by Ortho-Clinical Diagnostics, Inc.. It is a Class 2 Chemistry device (product code LPS) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K123930 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
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May 2013
Decision
146d
Days
Class 2
Risk

K123930 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE.... Classified as Urinary Homocystine (nonquantitative) Test System (product code LPS), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on May 15, 2013 after a review of 146 days - within the typical 510(k) review window.

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 Ortho-Clinical Diagnostics, Inc. devices

Submission Details

510(k) Number K123930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2012
Decision Date May 15, 2013
Days to Decision 146 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
58d slower than avg
Panel avg: 88d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 7
Devices cleared under the same product code (LPS) and FDA review panel - the closest regulatory comparables to K123930.
DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE
K063206 · Dade Behring, Inc. · Dec 2006
HEMOSIL HOMOCYSTEINE AND CONTROLS
K061598 · Instrumentation Laboratory CO · Sep 2006
VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS
K061588 · Ortho-Clinical Diagnostics, Inc. · Jul 2006
N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H
K052788 · Dade Behring, Inc. · Mar 2006
IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2
K003597 · Diagnostic Products Corp. · Feb 2001
BIO-RAD HOMOCYSTEINE BY HPLC
K993107 · Bio-Rad · Dec 1999