Cleared Traditional

K841955 - DUPONT ACA MAGNESIUM CALIBRATOR

K841955 is the FDA 510(k) clearance for DUPONT ACA MAGNESIUM CALIBRATOR by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 2 Chemistry device (product code JIS) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K841955 · E.I. Dupont DE Nemours & Co., Inc. · Chemistry device
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Jun 1984
Decision
42d
Days
Class 2
Risk

K841955 is an FDA 510(k) clearance for the DUPONT ACA MAGNESIUM CALIBRATOR. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Walker, US). The FDA issued a Cleared decision on June 25, 1984 after a review of 42 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 E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K841955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1984
Decision Date June 25, 1984
Days to Decision 42 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
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIS Calibrator, Primary
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 - JIS Calibrator, Primary

All 93
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K841955.
ROCHE STANDARDS FOR CHOLESTEROL
K843110 · Roche Diagnostic Systems, Inc. · Sep 1984
HICHEM ION 2/4 SERUM RANGE CALIBRATOR
K842449 · Hi Chem, Inc. · Aug 1984
HICHEM ION 2/4 URINE RANGE CALIBRATOR
K842450 · Hi Chem, Inc. · Aug 1984
PH ELECTRODE CALIBRATING BUFFERS-BLOOD
K840299 · Bionostics, Inc. · Mar 1984
PRECISET CHOLESTEROL HIGH PERFORM
K832251 · Boehringer Mannheim Corp. · Aug 1983
LITHIUM DILUENT
K830283 · Shaban Mfg. Co. · Feb 1983