Cleared Traditional

K854092 - DMA CALIBRATORS

K854092 is the FDA 510(k) clearance for DMA CALIBRATORS by Data Medical Associates, Inc.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K854092 · Data Medical Associates, Inc. · Chemistry device
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Oct 1985
Decision
18d
Days
Class 2
Risk

K854092 is an FDA 510(k) clearance for the DMA CALIBRATORS. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on October 25, 1985 after a review of 18 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 Data Medical Associates, Inc. devices

Submission Details

510(k) Number K854092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1985
Decision Date October 25, 1985
Days to Decision 18 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
70d faster than avg
Panel avg: 88d · This submission: 18d
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 K854092.
EMDS CHEMISTRY CALIBRATORS, LEVELS I & II
K860765 · Em Diagnostic Systems, Inc. · Apr 1986
QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A
K855014 · Kallestad Laboratories, Inc. · Mar 1986
PARAMAX COMPREHENSIVE CALIBRATOR
K855199 · American Dade · Feb 1986
CORNING CERTAIN -ISE
K851939 · Corning Medical & Scientific · Jun 1985
FISHER DIAGNOSTICS KDA CALIBRATOR I
K851150 · Fisher Scientific Co., LLC · May 1985
FISHER DIAGNOSTICS KDA CALIBRATOR II
K851151 · Fisher Scientific Co., LLC · May 1985