Cleared Traditional

K831030 - COBAS STANDARDS FOR GLUCOSE & BUN

K831030 is the FDA 510(k) clearance for COBAS STANDARDS FOR GLUCOSE & BUN by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K831030 · Roche Diagnostic Systems, Inc. · Chemistry device
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May 1983
Decision
40d
Days
Class 2
Risk

K831030 is an FDA 510(k) clearance for the COBAS STANDARDS FOR GLUCOSE & BUN. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1983 after a review of 40 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 K831030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1983
Decision Date May 09, 1983
Days to Decision 40 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
48d faster than avg
Panel avg: 88d · This submission: 40d
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 K831030.
PARAMAX BILIRUBIN CALIBRATORS
K833005 · American Dade · Nov 1983
LYPHOCHEK SERUM REF. STANDARD-BOVINE
K832695 · Bio-Rad · Oct 1983
SERALYZER MULTICOMPONENT CALIBRATORS
K832046 · Miles Laboratories, Inc. · Aug 1983
GLUCOSE/UREA NITROGEN STANDARD
K822937 · Emd Chemicals, Inc. · Nov 1982
CO2/CI STANDARDS
K822289 · Gilford Diagnostics · Aug 1982
BECKMAN ICS CALIBRATOR
K812649 · Beckman Instruments, Inc. · Oct 1981