Cleared Traditional

K897097 - COBAS READY CALIBRATOR KIT

K897097 is the FDA 510(k) clearance for COBAS READY CALIBRATOR KIT by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K897097 · Roche Diagnostic Systems, Inc. · Chemistry device
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Jun 1990
Decision
187d
Days
Class 2
Risk

K897097 is an FDA 510(k) clearance for the COBAS READY CALIBRATOR KIT. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on June 26, 1990 after a review of 187 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K897097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1989
Decision Date June 26, 1990
Days to Decision 187 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
99d slower than avg
Panel avg: 88d · This submission: 187d
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 K897097.
PARAMAX(R) ELECTROLYTE CALIBRATOR 1&2/MODIFICATION
K910309 · Baxter Healthcare Corp · Mar 1991
ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR
K904767 · Analytical Control Systems, Inc. · Dec 1990
PARAMAX URINE/CSF CALIBRATOR LEVEL I AND II
K903913 · Baxter Healthcare Corp · Sep 1990
CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE
K897177 · Nova Biomedical Corp. · Mar 1990
ROCHE STANDARDS FOR THE COBAS ISE MODULE
K897071 · Roche Diagnostic Systems, Inc. · Mar 1990
SODIUM AND POTASSIUM STANDARD
K895717 · Data Medical Associates, Inc. · Jan 1990