Cleared Traditional

K970420 - MASTERCAP AM 5.0/MASTERCAP RM 5.0 (FDA 510(k) Clearance)

Class I Chemistry device.

K970420 · Pharmacia, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
147d
Days
Class 1
Risk

K970420 is an FDA 510(k) clearance for the MASTERCAP AM 5.0/MASTERCAP RM 5.0. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Pharmacia, Inc. (Westervillle, US). The FDA issued a Cleared decision on June 30, 1997 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2750 - 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 Pharmacia, Inc. devices

Submission Details

510(k) Number K970420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1997
Decision Date June 30, 1997
Days to Decision 147 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
59d slower than avg
Panel avg: 88d · This submission: 147d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQW Station, Pipetting And Diluting, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2750
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.