Cleared Traditional

ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT (K971902) - FDA 510(k) Clearance

Class I Chemistry device.

K971902 · Roche Diagnostic Systems, Inc. · Chemistry device
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Jun 1997
Decision
24d
Days
Class 1
Risk

K971902 is an FDA 510(k) clearance for the ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on June 16, 1997 after a review of 24 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

Submission Details

510(k) Number K971902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1997
Decision Date June 16, 1997
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 88d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 79
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K971902.
AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A
K053157 · Dade Behring, Inc. · Dec 2005
ULTRA HDL
K051962 · Abbott Laboratories · Aug 2005
DIRECT HDL
K981224 · Abbott Laboratories · Aug 1998
HDL
K981580 · Abbott Laboratories · Jun 1998
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
K963213 · Boehringer Mannheim Corp. · Oct 1996
IQ HDL CHOLESTEROL
K881891 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1988