Cleared Traditional

K863095 - ACE II (TRI-LEVEL)

K863095 is the FDA 510(k) clearance for ACE II (TRI-LEVEL) by Medical Analysis Systems, Inc.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K863095 · Medical Analysis Systems, Inc. · Chemistry device
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Sep 1986
Decision
44d
Days
Class 2
Risk

K863095 is an FDA 510(k) clearance for the ACE II (TRI-LEVEL). Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Medical Analysis Systems, Inc. (Camarillo, US). The FDA issued a Cleared decision on September 26, 1986 after a review of 44 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 Medical Analysis Systems, Inc. devices

Submission Details

510(k) Number K863095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1986
Decision Date September 26, 1986
Days to Decision 44 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
44d faster than avg
Panel avg: 88d · This submission: 44d
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 K863095.
IRON & MAGNESIUM ADDITIONS/REFERRIL B CALIBRATOR
K871664 · Instrumentation Laboratory CO · May 1987
DU PONT LIQUID MULTI-ANALYTE CALIBRATOR
K864909 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1987
PARAMAX ELECTROLYTE CALIBRATOR
K863489 · American Dade · Sep 1986
EMDS(TM) ELEVATED LIPID CALIBRATOR #67626/95
K862703 · Em Diagnostic Systems, Inc. · Aug 1986
DU PONT DRUG CALIBRATOR
K861786 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1986
EMDS CHEMISTRY CALIBRATORS, LEVELS I & II
K860765 · Em Diagnostic Systems, Inc. · Apr 1986