Cleared Traditional

K940760 - FLUIDS PACK FOR CORING 238

K940760 is the FDA 510(k) clearance for FLUIDS PACK FOR CORING 238 by Alko Diagnostic Corp.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K940760 · Alko Diagnostic Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
200d
Days
Class 2
Risk

K940760 is an FDA 510(k) clearance for the FLUIDS PACK FOR CORING 238. 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 September 6, 1994 after a review of 200 days - an extended review 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: 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 Alko Diagnostic Corp. devices

Submission Details

510(k) Number K940760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1994
Decision Date September 06, 1994
Days to Decision 200 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
112d slower than avg
Panel avg: 88d · This submission: 200d
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 K940760.
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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
QUANTIMETRIX BLOOD GLUCOSE CONTROLS
K932623 · Quantimetrix Corp. · Dec 1993