Cleared Traditional

K944255 - DMA CALCIUM PLUS PROCEDURE

K944255 is an FDA 510(k) clearance for DMA CALCIUM PLUS PROCEDURE, manufactured by Data Medical Associates, Inc.. The device is a Class 2 Chemistry device with product code CJY cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K944255 · Data Medical Associates, Inc. · Chemistry device
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Dec 1994
Decision
96d
Days
Class 2
Risk

K944255 is an FDA 510(k) clearance for the DMA CALCIUM PLUS PROCEDURE. Classified as Azo Dye, Calcium (product code CJY), Class II - Special Controls.

Submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on December 6, 1994 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - 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 Data Medical Associates, Inc. devices

FDA 510(k) Submission Details - K944255

510(k) Number K944255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1994
Decision Date December 06, 1994
Days to Decision 96 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 88d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CJY Device Classification - Class 2, Special Controls

Product Code CJY Azo Dye, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
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 - CJY Azo Dye, Calcium

All 43
Devices cleared under the same product code (CJY) and FDA review panel - the closest regulatory comparables to K944255.
SIGMA DIAGNOSTICS CALICIUM REAGENT
K963536 · Sigma Diagnostics, Inc. · Oct 1996
EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE
K961226 · Johnson & Johnson Clinical Diagnostics, Inc. · May 1996
SYNERMED CALCIUM REAGENT KIT
K953395 · Synermed, Inc. · Aug 1995
HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808
K941764 · Hi Chem, Inc. · May 1994
SIGMA CALCIUM REAGENT
K933678 · Sigma Chemical Co. · Mar 1994
CALCIUM (AZ III) REAGENT
K922835 · King Diagnostics, Inc. · Aug 1992