Cleared Traditional

K854188 - IN VITRO TEST DETERMINATION OF INORGANI...

K854188 is the FDA 510(k) clearance for IN VITRO TEST DETERMINATION OF INORGANI... by Clinical Data, Inc.. It is a Class 1 Chemistry device (product code CEO) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K854188 · Clinical Data, Inc. · Chemistry device
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Nov 1985
Decision
41d
Days
Class 1
Risk

K854188 is an FDA 510(k) clearance for the IN VITRO TEST DETERMINATION OF INORGANIC PHOSPHORO. Classified as Phosphomolybdate (colorimetric), Inorganic Phosphorus (product code CEO), Class I - General Controls.

Submitted by Clinical Data, Inc. (Boston, US). The FDA issued a Cleared decision on November 25, 1985 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1580 - 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 Clinical Data, Inc. devices

Submission Details

510(k) Number K854188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1985
Decision Date November 25, 1985
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 88d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CEO Phosphomolybdate (colorimetric), Inorganic Phosphorus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1580
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CEO Phosphomolybdate (colorimetric), Inorganic Phosphorus

All 52
Devices cleared under the same product code (CEO) and FDA review panel - the closest regulatory comparables to K854188.
INORGANIC PHOSPHORUS PROCEDURE
K863264 · Data Medical Associates, Inc. · Sep 1986
MODEL 115-16 PHOSPHORUS (UV) ASSAY KIT
K862834 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1986
INORGANIC PHOSPHORUS PROCEDURE
K861661 · Data Medical Associates, Inc. · Jul 1986
INORGANIC PHOSPHORUS LIQUID STABLE REAGENT INORGAN
K852103 · Medical Analysis Systems, Inc. · May 1985
DATE CHEM INORGANIC PHOSPHOROUS U.V. PROCEDURE
K850986 · Data Medical Associates, Inc. · Apr 1985
INORGANIC PHOSPHORUS TEST
K843177 · Sclavo, Inc. · Sep 1984