Cleared Traditional

GAS TRAK PLUS (K884977) - FDA 510(k) Clearance

Class I Chemistry device.

K884977 · United Diagnostics, Inc. · Chemistry device
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Jan 1989
Decision
58d
Days
Class 1
Risk

K884977 is an FDA 510(k) clearance for the GAS TRAK PLUS. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by United Diagnostics, Inc. (Natick, US). The FDA issued a Cleared decision on January 27, 1989 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 United Diagnostics, Inc. devices

Submission Details

510(k) Number K884977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1988
Decision Date January 27, 1989
Days to Decision 58 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 88d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 184
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K884977.
LYPHOCHEK TUMOR MARKER CONTROLS, LEVELS I AND II
K891680 · Bio-Rad · Jun 1989
MONI-TROL(R)
K891929 · Baxter Healthcare Corp · May 1989
RIATRAC PLUS
K890470 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1989
LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II
K882486 · Bio-Rad · Oct 1988
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL (BOVINE)I/II
K882542 · Bio-Rad · Jul 1988
MODIFIED DADE COMPRE. ELECTROPHORESIS CONTROL
K881503 · Baxter Healthcare Corp · Jul 1988