Cleared Traditional

K100550 - POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC

K100550 is an FDA 510(k) clearance for POLY-CHEM 90 DIRECT HDL CHOLESTEROL, manufactured by Polymedco, Inc.. The device is a Class 1 Chemistry device with product code LBS cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K100550 · Polymedco, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
214d
Days
Class 1
Risk

K100550 is an FDA 510(k) clearance for the POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POL.... Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Polymedco, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on September 28, 2010 after a review of 214 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 Polymedco, Inc. devices

FDA 510(k) Submission Details - K100550

510(k) Number K100550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2010
Decision Date September 28, 2010
Days to Decision 214 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
126d slower than avg
Panel avg: 88d · This submission: 214d
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 K100550.
NMR LIPOPROFILE (R) TEST AND NMR PROFILER
K111516 · Liposcience, Inc. · Sep 2011
ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS
K103747 · Elitechgroup Seppim S.A.S. · Aug 2011
EASYRA HDL REAGENT
K111036 · Medica Corporation · Jul 2011
HDL CHOLESTEROL (HDLX) ASSAY
K100010 · Beckman Coulter, Inc. · May 2010
APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201
K080125 · Wako Chemicals USA, Inc. · Jul 2008
HDL CHOLESTEROL REAGENT, MODEL 10211
K073497 · Medica Corp. · Apr 2008