Cleared Traditional

K973369 - ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)

K973369 is an FDA 510(k) clearance for ROCHE UNIMATE HDL DIRECT REAGEN (WITH P..., manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 1 Chemistry device with product code LBR cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K973369 · Roche Diagnostic Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
74d
Days
Class 1
Risk

K973369 is an FDA 510(k) clearance for the ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM). Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on November 21, 1997 after a review of 74 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 Roche Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K973369

510(k) Number K973369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1997
Decision Date November 21, 1997
Days to Decision 74 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 88d · This submission: 74d
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 53
Devices cleared under the same product code (LBR) and FDA review panel - the closest regulatory comparables to K973369.
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
BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL
K974733 · Boehringer Mannheim Corp. · Jan 1998
N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET
K971573 · Genzyme Corp. · Jun 1997
TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN
K962723 · Trace America, Inc. · Mar 1997
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
K962186 · Genzyme Corp. · Aug 1996