Cleared Traditional

K013152 - ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS

K013152 is an FDA 510(k) clearance for ATAC PAK DIRECT HDL REAGENT AND ATAC DI..., manufactured by Elan Holdings, Inc.. The device is a Class 1 Chemistry device with product code LBS cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K013152 · Elan Holdings, Inc. · Chemistry device
Download Printable Device Report (PDF)
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Nov 2001
Decision
50d
Days
Class 1
Risk

K013152 is an FDA 510(k) clearance for the ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Elan Holdings, Inc. (Brea, US). The FDA issued a Cleared decision on November 9, 2001 after a review of 50 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Elan Holdings, Inc. devices

FDA 510(k) Submission Details - K013152

510(k) Number K013152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2001
Decision Date November 09, 2001
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 88d · This submission: 50d
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 70
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K013152.
JAS HDL CHOLESTEROL (AUTOMATED) REAGENT
K021671 · Jas Diagnostics, Inc. · Jul 2002
OLYMPUS HDL CHOLESTEROL REAGENT
K014015 · Olympus America, Inc. · Feb 2002
OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA
K014032 · Olympus America, Inc. · Feb 2002
MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
K012286 · Roche Diagnostics Corp. · Aug 2001
LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01
K991664 · A.P. Total Care, Inc. · Aug 1999
HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01
K991665 · A.P. Total Care, Inc. · Aug 1999