Cleared Traditional

K032936 - DIRECT LDL CHOLESTEROL LIQUID COLOR AND...

K032936 is the FDA 510(k) clearance for DIRECT LDL CHOLESTEROL LIQUID COLOR AND... by Stanbio Laboratory. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K032936 · Stanbio Laboratory · Chemistry device
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Mar 2004
Decision
172d
Days
Class 2
Risk

K032936 is an FDA 510(k) clearance for the DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CA.... Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Stanbio Laboratory (Boerne, US). The FDA issued a Cleared decision on March 12, 2004 after a review of 172 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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.

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Submission Details

510(k) Number K032936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2003
Decision Date March 12, 2004
Days to Decision 172 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
84d slower than avg
Panel avg: 88d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIX Calibrator, Multi-analyte Mixture

All 183
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K032936.
N APOLIPOPROTEIN STANDARD SERUM
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K040245 · Roche Diagnostics Corp. · Mar 2004
BAYER SPECIFIC PROTEIN REFERENCE SERUM
K033791 · Bayer Healthcare, LLC · Feb 2004
ELECSYS C-PEPTIDE CALSET
K033873 · Roche Diagnostics Corp. · Feb 2004
OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071
K032665 · Olympus America, Inc. · Nov 2003