Cleared Traditional

K944639 - DOCUMENTR AMMONIA/ETHANOLCALIBRATOR

K944639 is the FDA 510(k) clearance for DOCUMENTR AMMONIA/ETHANOLCALIBRATOR by Casco Standards. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K944639 · Casco Standards · Chemistry device
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Optimized for regulatory review, auditing and printing
Nov 1994
Decision
55d
Days
Class 2
Risk

K944639 is an FDA 510(k) clearance for the DOCUMENTR AMMONIA/ETHANOLCALIBRATOR. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Casco Standards (Yarmouth, US). The FDA issued a Cleared decision on November 15, 1994 after a review of 55 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 Casco Standards devices

Submission Details

510(k) Number K944639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1994
Decision Date November 15, 1994
Days to Decision 55 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
33d faster than avg
Panel avg: 88d · This submission: 55d
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 204
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K944639.
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
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
QUANTIMETRIX BLOOD GLUCOSE CONTROLS
K932623 · Quantimetrix Corp. · Dec 1993