Cleared Traditional

K860765 - EMDS CHEMISTRY CALIBRATORS

K860765 is the FDA 510(k) clearance for EMDS CHEMISTRY CALIBRATORS by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K860765 · Em Diagnostic Systems, Inc. · Chemistry device
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Apr 1986
Decision
35d
Days
Class 2
Risk

K860765 is an FDA 510(k) clearance for the EMDS CHEMISTRY CALIBRATORS, LEVELS I & II. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on April 7, 1986 after a review of 35 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K860765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1986
Decision Date April 07, 1986
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 88d · This submission: 35d
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 201
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K860765.
ACE II (TRI-LEVEL)
K863095 · Medical Analysis Systems, Inc. · Sep 1986
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K862703 · Em Diagnostic Systems, Inc. · Aug 1986
DU PONT DRUG CALIBRATOR
K861786 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1986
QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A
K855014 · Kallestad Laboratories, Inc. · Mar 1986
PARAMAX COMPREHENSIVE CALIBRATOR
K855199 · American Dade · Feb 1986
DMA CALIBRATORS
K854092 · Data Medical Associates, Inc. · Oct 1985