Cleared Traditional

K974733 - BOEHRINGER MANNHEIM DIRECT LDL - CHOLES...

K974733 is an FDA 510(k) clearance for BOEHRINGER MANNHEIM DIRECT LDL - CHOLES..., manufactured by Boehringer Mannheim Corp.. The device is a Class 1 Chemistry device with product code LBR cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K974733 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
39d
Days
Class 1
Risk

K974733 is an FDA 510(k) clearance for the BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL. Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 26, 1998 after a review of 39 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K974733

510(k) Number K974733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1997
Decision Date January 26, 1998
Days to Decision 39 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 88d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

LBR Device Classification - Class 1, General Controls

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 38
Devices cleared under the same product code (LBR) and FDA review panel - the closest regulatory comparables to K974733.
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT
K984303 · Ortho-Clinical Diagnostics, Inc. · Jan 1999
HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51
K980772 · Diagnostic Chemicals , Ltd. · Apr 1998
HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51
K980770 · Diagnostic Chemicals , Ltd. · Apr 1998
ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)
K973369 · Roche Diagnostic Systems, Inc. · Nov 1997
N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET
K971573 · Genzyme Corp. · Jun 1997
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
K962186 · Genzyme Corp. · Aug 1996