Cleared Traditional

K964063 - RDI LDL PRECIPITATION REAGENT

K964063 is an FDA 510(k) clearance for RDI LDL PRECIPITATION REAGENT, 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 41-day FDA review.

K964063 · Reference Diagnostics, Inc. · Chemistry device
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Nov 1996
Decision
41d
Days
Class 1
Risk

K964063 is an FDA 510(k) clearance for the RDI LDL PRECIPITATION REAGENT. 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 November 20, 1996 after a review of 41 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 - K964063

510(k) Number K964063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1996
Decision Date November 20, 1996
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 88d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 Consultant

Rdd Consultants, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K964063.
RANDOX DIRECT LDL CHOLESTEROL
K982529 · Randox Laboratories, Ltd. · Sep 1998
DIRECT LDL
K981303 · Abbott Laboratories · Aug 1998
AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR
K981978 · Pointe Scientific, Inc., · Jul 1998
RDI LIPIDIRECT MAGNETIC LDL REAGENT
K964064 · Reference Diagnostics, Inc. · Nov 1996
EKTACHEM DT LDL CHOLESTEROL KIT
K955904 · Johnson & Johnson Clinical Diagnostics, Inc. · May 1996
DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT
K943150 · Genzyme Corp. · Mar 1995