Cleared Traditional

K863566 - GSC 1000

K863566 is the FDA 510(k) clearance for GSC 1000 by Genetic Systems Corp.. It is a Class 1 Chemistry device (product code JJQ) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K863566 · Genetic Systems Corp. · Chemistry device
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Oct 1986
Decision
34d
Days
Class 1
Risk

K863566 is an FDA 510(k) clearance for the GSC 1000. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Genetic Systems Corp. (Seattle, US). The FDA issued a Cleared decision on October 16, 1986 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2300 - 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 Genetic Systems Corp. devices

Submission Details

510(k) Number K863566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1986
Decision Date October 16, 1986
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 88d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
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 - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 135
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K863566.
OHMEDA 6000 MULTI-GAS MONITOR
K863959 · Ohmeda Medical · Jan 1987
TERUMO OVATION SPECTROPHOTOMETER
K864285 · Terumo Medical Corp. · Jan 1987
TDX(R) II ANALYZER
K864319 · Abbott Laboratories · Dec 1986
BEHRING RAPIMAT II
K861263 · Behring Diagnostics, Inc. · Oct 1986
UNISKAN II
K861897 · Flow Laboratories, Inc. · Jul 1986
THE PARTNER SPECTROPHOTOMETER
K861617 · Pharmacia, Inc. · May 1986