Cleared Traditional

K850334 - ROCHE REAGENT FOR CHLORIDE

K850334 is the FDA 510(k) clearance for ROCHE REAGENT FOR CHLORIDE by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CHJ) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K850334 · Roche Diagnostic Systems, Inc. · Chemistry device
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Mar 1985
Decision
45d
Days
Class 2
Risk

K850334 is an FDA 510(k) clearance for the ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS. Classified as Mercuric Thiocyanate, Colorimetry, Chloride (product code CHJ), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Nutley, US). The FDA issued a Cleared decision on March 14, 1985 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1170 - 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 K850334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1985
Decision Date March 14, 1985
Days to Decision 45 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
43d faster than avg
Panel avg: 88d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CHJ Mercuric Thiocyanate, Colorimetry, Chloride
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1170
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CHJ Mercuric Thiocyanate, Colorimetry, Chloride

All 33
Devices cleared under the same product code (CHJ) and FDA review panel - the closest regulatory comparables to K850334.
CHLORIDE PROCEDURE
K861674 · Data Medical Associates, Inc. · Jul 1986
CHLORIDE REAGENT
K852169 · Pointe Scientific, Inc., · Aug 1985
CHLORIDE ASSAY KIT
K852058 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1985
SCLAVO CHLORIDE TEST
K843740 · Sclavo, Inc. · Oct 1984
CHLORIDE TEST KIT
K842011 · Mallinckrodt Critical Care · Jun 1984
PARAMAX CHLORIDE REAGENT
K841047 · American Dade · Apr 1984