Cleared Traditional

K984107 - RDI DIRECT LDL CHOLESTEROL TEST

K984107 is an FDA 510(k) clearance for RDI DIRECT LDL CHOLESTEROL TEST, manufactured by Reference Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code MRR cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K984107 · Reference Diagnostics, Inc. · Chemistry device
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Jan 1999
Decision
72d
Days
Class 1
Risk

K984107 is an FDA 510(k) clearance for the RDI DIRECT LDL CHOLESTEROL TEST. Classified as System, Test, Low Density, Lipoprotein (product code MRR), Class I - General Controls.

Submitted by Reference Diagnostics, Inc. (Bedford, US). The FDA issued a Cleared decision on January 28, 1999 after a review of 72 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 Reference Diagnostics, Inc. devices

FDA 510(k) Submission Details - K984107

510(k) Number K984107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1998
Decision Date January 28, 1999
Days to Decision 72 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 88d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

MRR Device Classification - Class 1, General Controls

Product Code MRR System, Test, Low Density, Lipoprotein
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 - MRR System, Test, Low Density, Lipoprotein

All 26
Devices cleared under the same product code (MRR) and FDA review panel - the closest regulatory comparables to K984107.
EZ LDL CHOLESTEROL TEST SYSTEM
K993741 · Sigma Diagnostics, Inc. · Jul 2000
N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET
K992766 · Genzyme Corp. · Oct 1999
ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS
K991733 · Schiapparelli Biosystems, Inc. · Jul 1999
COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT
K982848 · Roche Diagnostic Systems, Inc. · Oct 1998
WAKO DIRECT LDL-C
K982271 · Wako Chemicals USA, Inc. · Sep 1998
RANDOX DIRECT LDL CHOLESTEROL
K982529 · Randox Laboratories, Ltd. · Sep 1998