Cleared Traditional

K032932 - DIRECT HDL-CHOLESTEROL LIQUID COLOR

Also marketed or referenced as:
DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR

K032932 is an FDA 510(k) clearance for DIRECT HDL-CHOLESTEROL LIQUID COLOR, manufactured by Stanbio Laboratory. The device is a Class 1 Chemistry device with product code LBS cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K032932 · Stanbio Laboratory · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
170d
Days
Class 1
Risk

K032932 is an FDA 510(k) clearance for the DIRECT HDL-CHOLESTEROL LIQUID COLOR. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Stanbio Laboratory (Boerne, US). The FDA issued a Cleared decision on March 10, 2004 after a review of 170 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - 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 Stanbio Laboratory devices

FDA 510(k) Submission Details - K032932

510(k) Number K032932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2003
Decision Date March 10, 2004
Days to Decision 170 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
82d slower than avg
Panel avg: 88d · This submission: 170d
Pathway characteristics
Predicate-based equivalence.

LBS Device Classification - Class 1, General Controls

Product Code LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl

All 69
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K032932.
VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE
K042006 · Ortho-Clinical Diagnostics, Inc. · Oct 2004
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747
K042195 · Beckman Coulter, Inc. · Sep 2004
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT
K040767 · Beckman Coulter, Inc. · Jun 2004
HDL-CHOLESTEROL PLUS 2ND GENERATION
K033610 · Roche Diagnostics Corp. · Dec 2003
PICCOLO HDL TEST SYSTEM
K023640 · Abaxis, Inc. · Jan 2003
ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2
K021316 · Genzyme Corp. · Jul 2002