Cleared Traditional

K931773 - HDL PRECIPITATING REAGENT (DEXTRAN SULF...

K931773 is the FDA 510(k) clearance for HDL PRECIPITATING REAGENT (DEXTRAN SULF... by King Diagnostics, Inc.. It is a Class 1 Chemistry device (product code LBR) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K931773 · King Diagnostics, Inc. · Chemistry device
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Aug 1993
Decision
129d
Days
Class 1
Risk

K931773 is an FDA 510(k) clearance for the HDL PRECIPITATING REAGENT (DEXTRAN SULFATE). Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by King Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on August 16, 1993 after a review of 129 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 King Diagnostics, Inc. devices

Submission Details

510(k) Number K931773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1993
Decision Date August 16, 1993
Days to Decision 129 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
41d slower than avg
Panel avg: 88d · This submission: 129d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 33
Devices cleared under the same product code (LBR) and FDA review panel - the closest regulatory comparables to K931773.
BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL
K974733 · Boehringer Mannheim Corp. · Jan 1998
ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)
K973369 · Roche Diagnostic Systems, Inc. · Nov 1997
HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)
K932766 · Diagnostic Chemicals, Ltd. (Usa) · Dec 1993
SYNERMED HDL CHOLESTLEROL REAGENT KIT
K924427 · Synermed, Inc. · Nov 1992
IL TEST(TM) HDL CHOLESTEROL
K914811 · Instrumentation Laboratory CO · Jan 1992
HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173
K905284 · Amresco, Inc. · Dec 1990