Cleared Traditional

K992834 - GEM PREMIER 3000

K992834 is the FDA 510(k) clearance for GEM PREMIER 3000 by Instrumentation Laboratory CO. It is a Class 2 Chemistry device (product code CHL) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K992834 · Instrumentation Laboratory CO · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
93d
Days
Class 2
Risk

K992834 is an FDA 510(k) clearance for the GEM PREMIER 3000. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on November 24, 1999 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1120 - 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 Instrumentation Laboratory CO devices

Submission Details

510(k) Number K992834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1999
Decision Date November 24, 1999
Days to Decision 93 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 88d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

All 86
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K992834.
STAT PROFILE PHOX PLUS L ANALYZER
K012058 · Nova Biomedical Corp. · Aug 2001
BAYER RAPIDPOINT 400 SYSTEM
K002738 · Bayer Corp. · Dec 2000
MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER
K002613 · Nova Biomedical Corp. · Oct 2000
MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)
K982277 · Nova Biomedical Corp. · Jul 1998
NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER
K980991 · Nova Biomedical Corp. · Apr 1998
STAT PROFILE ULTRA M ANALYZER
K970710 · Nova Biomedical Corp. · May 1997