Cleared Traditional

MAGNETIC HDL CHOLESTEROL TEST (K944975) - FDA 510(k) Clearance

Class I Chemistry device.

K944975 · Reference Diagnostics, Inc. · Chemistry device
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Aug 1995
Decision
295d
Days
Class 1
Risk

K944975 is an FDA 510(k) clearance for the MAGNETIC HDL CHOLESTEROL TEST. Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by Reference Diagnostics, Inc. (Bedford, US). The FDA issued a Cleared decision on August 2, 1995 after a review of 295 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 Reference Diagnostics, Inc. devices

Submission Details

510(k) Number K944975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1994
Decision Date August 02, 1995
Days to Decision 295 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 88d · This submission: 295d
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 65
Devices cleared under the same product code (LBR) and FDA review panel - the closest regulatory comparables to K944975.
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
IL TEST(TM) HDL CHOLESTEROL
K914811 · Instrumentation Laboratory CO · Jan 1992
REFLOTRON HDL CHOLESTEROL TEST TABS
K902568 · Boehringer Mannheim Corp. · Aug 1990
ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL
K900120 · Roche Diagnostic Systems, Inc. · Mar 1990
HDL CHOLESTEROL TEST
K885265 · Em Diagnostic Systems, Inc. · Feb 1989