Cleared Traditional

K963498 - FERR FLEX REAGENT CARTRIDGE

K963498 is an FDA 510(k) clearance for FERR FLEX REAGENT CARTRIDGE, manufactured by Dade Chemistry Systems, Inc.. The device is a Class 2 Chemistry device with product code JMG cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K963498 · Dade Chemistry Systems, Inc. · Chemistry device
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Jan 1997
Decision
143d
Days
Class 2
Risk

K963498 is an FDA 510(k) clearance for the FERR FLEX REAGENT CARTRIDGE. Classified as Radioimmunoassay (two-site Solid Phase), Ferritin (product code JMG), Class II - Special Controls.

Submitted by Dade Chemistry Systems, Inc. (Newark, US). The FDA issued a Cleared decision on January 24, 1997 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5340 - 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 Dade Chemistry Systems, Inc. devices

FDA 510(k) Submission Details - K963498

510(k) Number K963498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1996
Decision Date January 24, 1997
Days to Decision 143 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 88d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JMG Device Classification - Class 2, Special Controls

Product Code JMG Radioimmunoassay (two-site Solid Phase), Ferritin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5340
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 - JMG Radioimmunoassay (two-site Solid Phase), Ferritin

All 20
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