Cleared Traditional

K050823 - DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR

K050823 is an FDA 510(k) clearance for DIRECT HDL CHOLESTEROL AND DIRECT HDL/L..., manufactured by Teco Diagnostics. The device is a Class 1 Chemistry device with product code LBR cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K050823 · Teco Diagnostics · Chemistry device
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Jul 2005
Decision
117d
Days
Class 1
Risk

K050823 is an FDA 510(k) clearance for the DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR. Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on July 26, 2005 after a review of 117 days - within the typical 510(k) review window.

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 Teco Diagnostics devices

FDA 510(k) Submission Details - K050823

510(k) Number K050823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2005
Decision Date July 26, 2005
Days to Decision 117 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 88d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

LBR Device Classification - Class 1, General Controls

Product Code LBR Ldl & Vldl Precipitation, 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 - LBR Ldl & Vldl Precipitation, Hdl

All 57
Devices cleared under the same product code (LBR) and FDA review panel - the closest regulatory comparables to K050823.
LDLC3 LDL-Cholesterol Gen.3
K143691 · Roche Diagnostics Operations (Rdo) · Jan 2015
DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS
K072523 · General Atomics · Jan 2008
RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER
K023784 · Hemagen Diagnostics, Inc. · Dec 2002
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
K012593 · Ortho-Clinical Diagnostics, Inc. · Aug 2001
ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
K992029 · Elan Diagnostics · Aug 1999
AUTOHDL CHOLESTEROL REAGENT SET
K992002 · Pointe Scientific, Inc., · Aug 1999