Cleared Traditional

K973988 - RDI HOMOGENEOUS HDL CHOLESTEROL TEST

K973988 is an FDA 510(k) clearance for RDI HOMOGENEOUS HDL CHOLESTEROL TEST, manufactured by Reference Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code LBS cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K973988 · Reference Diagnostics, Inc. · Chemistry device
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Dec 1997
Decision
62d
Days
Class 1
Risk

K973988 is an FDA 510(k) clearance for the RDI HOMOGENEOUS HDL CHOLESTEROL TEST. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Reference Diagnostics, Inc. (Bedford, US). The FDA issued a Cleared decision on December 22, 1997 after a review of 62 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 - K973988

510(k) Number K973988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1997
Decision Date December 22, 1997
Days to Decision 62 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
26d faster than avg
Panel avg: 88d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

LBS Device Classification - Class 1, General Controls

Product Code LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, 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 - LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl

All 64
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K973988.
DIRECT HDL
K981224 · Abbott Laboratories · Aug 1998
DIRECT HDL-CHOLESTROL LIQUID
K982341 · Randox Laboratories, Ltd. · Jul 1998
HDL
K981580 · Abbott Laboratories · Jun 1998
EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5)
K972041 · Sigma Diagnostics, Inc. · Jul 1997
LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR
K971162 · Genzyme Corp. · Jun 1997
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
K971190 · Genzyme Corp. · Jun 1997