Cleared Traditional

ROCHE COBAS READY HDL CHOLESTEROL REAGENT (K902935) - FDA 510(k) Clearance

Class I Chemistry device.

K902935 · Roche Diagnostic Systems, Inc. · Chemistry device
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Sep 1990
Decision
86d
Days
Class 1
Risk

K902935 is an FDA 510(k) clearance for the ROCHE COBAS READY HDL CHOLESTEROL REAGENT. Classified as Colorimetric Method, Lipoproteins (product code JHM), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on September 27, 1990 after a review of 86 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 K902935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1990
Decision Date September 27, 1990
Days to Decision 86 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 88d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JHM Colorimetric Method, Lipoproteins
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 - JHM Colorimetric Method, Lipoproteins

All 8
Devices cleared under the same product code (JHM) and FDA review panel - the closest regulatory comparables to K902935.
DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B
K073072 · Dade Behring, Inc. · Feb 2008
DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A
K032798 · Dade Behring, Inc. · Oct 2003
DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE
K983849 · Dade Behring, Inc. · Jan 1999