Cleared Traditional

K885263 - QMS(TM) - THEOPHYLLINE

K885263 is the FDA 510(k) clearance for QMS(TM) - THEOPHYLLINE by Seradyn, Inc.. It is a Class 1 Chemistry device (product code JQX) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K885263 · Seradyn, Inc. · Chemistry device
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Mar 1989
Decision
95d
Days
Class 1
Risk

K885263 is an FDA 510(k) clearance for the QMS(TM) - THEOPHYLLINE. Classified as Nephelometer, For Clinical Use (product code JQX), Class I - General Controls.

Submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on March 28, 1989 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2700 - 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 Seradyn, Inc. devices

Submission Details

510(k) Number K885263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1988
Decision Date March 28, 1989
Days to Decision 95 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 88d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQX Nephelometer, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2700
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.

Regulatory Peers - JQX Nephelometer, For Clinical Use

All 10
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IMMAGE IMMUNOCHEMISTRY SYSTEM
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K801089 · J.T. Baker Chemical Co. · May 1980