Cleared Traditional

K945966 - ALKO CALIBRATORS AND FLUSH SOLUTION FOR...

K945966 is the FDA 510(k) clearance for ALKO CALIBRATORS AND FLUSH SOLUTION FOR... by Alko Diagnostic Corp.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K945966 · Alko Diagnostic Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
65d
Days
Class 2
Risk

K945966 is an FDA 510(k) clearance for the ALKO CALIBRATORS AND FLUSH SOLUTION FOR IL 1300 SERIES PH/BLOOD GAS ANALYZERS. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Alko Diagnostic Corp. (Holliston, US). The FDA issued a Cleared decision on February 10, 1995 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Alko Diagnostic Corp. devices

Submission Details

510(k) Number K945966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1994
Decision Date February 10, 1995
Days to Decision 65 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 88d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIX Calibrator, Multi-analyte Mixture

All 202
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K945966.
ROCHE CALIBRATOR SERUM
K942706 · Roche Diagnostic Systems, Inc. · Sep 1995
ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR
K952282 · Roche Diagnostic Systems, Inc. · Sep 1995
HICHEM ISE STANDARDS KIT 70011
K953863 · Hichem Diagnostics · Sep 1995
DOCUMENTR AMMONIA/ETHANOLCALIBRATOR
K944639 · Casco Standards · Nov 1994
SYNERMEDIR CAL I AND SYNERMED IR CAL II
K940571 · Synermed, Inc. · Apr 1994
ACA PLUS FERRITIN CALIBRATOR
K935543 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1994