Cleared Traditional

K940571 - SYNERMEDIR CAL I AND SYNERMED IR CAL II

K940571 is the FDA 510(k) clearance for SYNERMEDIR CAL I AND SYNERMED IR CAL II by Synermed, Inc.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K940571 · Synermed, Inc. · Chemistry device
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Apr 1994
Decision
72d
Days
Class 2
Risk

K940571 is an FDA 510(k) clearance for the SYNERMEDIR CAL I AND SYNERMED IR CAL II. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Synermed, Inc. (Quebec, Canada, CA). The FDA issued a Cleared decision on April 21, 1994 after a review of 72 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 Synermed, Inc. devices

Submission Details

510(k) Number K940571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1994
Decision Date April 21, 1994
Days to Decision 72 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 88d · This submission: 72d
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 206
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K940571.
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HICHEM ISE STANDARDS KIT 70011
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DOCUMENTR AMMONIA/ETHANOLCALIBRATOR
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K935543 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1994
QUANTIMETRIX BLOOD GLUCOSE CONTROLS
K932623 · Quantimetrix Corp. · Dec 1993
CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323
K932768 · Helena Laboratories · Oct 1993