Cleared Traditional

K850396 - ROCHE STANDARDS FOR CHLORIDE & CO2

K850396 is the FDA 510(k) clearance for ROCHE STANDARDS FOR CHLORIDE & CO2 by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K850396 · Roche Diagnostic Systems, Inc. · Chemistry device
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Feb 1985
Decision
26d
Days
Class 2
Risk

K850396 is an FDA 510(k) clearance for the ROCHE STANDARDS FOR CHLORIDE & CO2. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Nutley, US). The FDA issued a Cleared decision on February 27, 1985 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 K850396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1985
Decision Date February 27, 1985
Days to Decision 26 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
62d faster than avg
Panel avg: 88d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIX Calibrator, Multi-analyte Mixture

All 183
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K850396.
FISHER DIAGNOSTICS KDA CALIBRATOR II
K851151 · Fisher Scientific Co., LLC · May 1985
COBAS CALIBRATOR SERUM
K850859 · Roche Diagnostic Systems, Inc. · May 1985
CALIBRATOR B 88133
K850405 · Hi Chem, Inc. · Apr 1985
REFERRIL CALIBRATORS
K844585 · Instrumentation Laboratory CO · Dec 1984
CHANGES IN THE CHEMICAL COMP. OF 5
K841464 · Nova Biomedical Corp. · Jun 1984
PARAMAX BILIRUBIN CALIBRATORS
K833005 · American Dade · Nov 1983