Cleared Traditional

K970330 - DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE

K970330 is an FDA 510(k) clearance for DADE INDIRECT IMT SYSTEM WITH TCO2 ELEC..., manufactured by Dade Intl., Inc.. The device is a Class 2 Chemistry device with product code CEM cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K970330 · Dade Intl., Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
76d
Days
Class 2
Risk

K970330 is an FDA 510(k) clearance for the DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by Dade Intl., Inc. (Newark, US). The FDA issued a Cleared decision on April 14, 1997 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1600 - 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 Dade Intl., Inc. devices

FDA 510(k) Submission Details - K970330

510(k) Number K970330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1997
Decision Date April 14, 1997
Days to Decision 76 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 88d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEM Device Classification - Class 2, Special Controls

Product Code CEM Electrode, Ion Specific, Potassium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1600
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 - CEM Electrode, Ion Specific, Potassium

All 67
Devices cleared under the same product code (CEM) and FDA review panel - the closest regulatory comparables to K970330.
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K961115 · Johnson & Johnson Clinical Diagnostics, Inc. · May 1996
DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD
K932044 · Dupont Medical Products · Jul 1993