Cleared Traditional

K974322 - ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM

K974322 is an FDA 510(k) clearance for ABCA-NT GAS ISOTOPE RATIO MASS SPECTROM..., manufactured by Europa Scientific, Ltd.. The device is a Class 1 Toxicology device with product code DOP cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K974322 · Europa Scientific, Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
29d
Days
Class 1
Risk

K974322 is an FDA 510(k) clearance for the ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM. Classified as Mass Spectrometer, Clinical Use (product code DOP), Class I - General Controls.

Submitted by Europa Scientific, Ltd. (Concord, US). The FDA issued a Cleared decision on December 16, 1997 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2860 - the FDA toxicology device 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 Europa Scientific, Ltd. devices

FDA 510(k) Submission Details - K974322

510(k) Number K974322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1997
Decision Date December 16, 1997
Days to Decision 29 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 87d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

DOP Device Classification - Class 1, General Controls

Product Code DOP Mass Spectrometer, Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2860
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 - DOP Mass Spectrometer, Clinical Use

Devices cleared under the same product code (DOP) and FDA review panel - the closest regulatory comparables to K974322.
ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS
K992163 · Pdz-Europa , Ltd. · Jul 1999
ION TRAP DETECTOR (ITD)
K872464 · The Perkin-Elmer Corp. · Aug 1987
MASS SPECTROMETER-MEDSPECT II
K810938 · Allied Healthcare Products, Inc. · Apr 1981
FURNACE AUTOSAMPLER, MODEL 155
K770994 · Instrumentation Laboratory CO · Aug 1977
MERCURY/HYDRIDE SYSTEM MHS-1
K770637 · The Perkin-Elmer Corp. · Jun 1977