Cleared Traditional

K970735 - BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL

K970735 is an FDA 510(k) clearance for BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL, manufactured by Randox Laboratories, Ltd.. The device is a Class 1 Chemistry device with product code LBS cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K970735 · Randox Laboratories, Ltd. · Chemistry device
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Jun 1997
Decision
108d
Days
Class 1
Risk

K970735 is an FDA 510(k) clearance for the BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, IE). The FDA issued a Cleared decision on June 6, 1997 after a review of 108 days - within the typical 510(k) review window.

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 Randox Laboratories, Ltd. devices

FDA 510(k) Submission Details - K970735

510(k) Number K970735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1997
Decision Date June 06, 1997
Days to Decision 108 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
20d slower than avg
Panel avg: 88d · This submission: 108d
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 71
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K970735.
LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR
K971162 · Genzyme Corp. · Jun 1997
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
K971190 · Genzyme Corp. · Jun 1997
ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT
K971902 · Roche Diagnostic Systems, Inc. · Jun 1997
ACE HDL-C REAGENT
K971526 · Schiapparelli Biosystems, Inc. · May 1997
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
K963213 · Boehringer Mannheim Corp. · Oct 1996
CHOLESTECH LDX SYSTEM
K954778 · Cholestech Corp. · Nov 1995