Cleared Traditional

K941744 - PBI PLUS HDL PRECIPITATING REAGENT

K941744 is an FDA 510(k) clearance for PBI PLUS HDL PRECIPITATING REAGENT, manufactured by Merchant House Scientific. The device is a Class 1 Chemistry device with product code LBR cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K941744 · Merchant House Scientific · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
152d
Days
Class 1
Risk

K941744 is an FDA 510(k) clearance for the PBI PLUS HDL PRECIPITATING REAGENT. Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by Merchant House Scientific (Irvine, US). The FDA issued a Cleared decision on September 6, 1994 after a review of 152 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 Merchant House Scientific devices

FDA 510(k) Submission Details - K941744

510(k) Number K941744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1994
Decision Date September 06, 1994
Days to Decision 152 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
64d slower than avg
Panel avg: 88d · This submission: 152d
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 55
Devices cleared under the same product code (LBR) and FDA review panel - the closest regulatory comparables to K941744.
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
K962186 · Genzyme Corp. · Aug 1996
HDL PRECIPITATING REAGENT
K954179 · Schiapparelli Biosystems, Inc. · Dec 1995
MAGNETIC HDL CHOLESTEROL TEST
K944975 · Reference Diagnostics, Inc. · Aug 1995
HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)
K932766 · Diagnostic Chemicals, Ltd. (Usa) · Dec 1993
INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET
K934039 · Intersect Systems, Inc. · Nov 1993
HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)
K931773 · King Diagnostics, Inc. · Aug 1993