Cleared Traditional

K823580 - COBAS REAGENT FOR INORGANIC PHOSPHORUS

K823580 is the FDA 510(k) clearance for COBAS REAGENT FOR INORGANIC PHOSPHORUS by Hoffmann-La Roche, Inc.. It is a Class 1 Chemistry device (product code CEO) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K823580 · Hoffmann-La Roche, Inc. · Chemistry device
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Jan 1983
Decision
32d
Days
Class 1
Risk

K823580 is an FDA 510(k) clearance for the COBAS REAGENT FOR INORGANIC PHOSPHORUS. Classified as Phosphomolybdate (colorimetric), Inorganic Phosphorus (product code CEO), Class I - General Controls.

Submitted by Hoffmann-La Roche, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 7, 1983 after a review of 32 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 Hoffmann-La Roche, Inc. devices

Submission Details

510(k) Number K823580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1982
Decision Date January 07, 1983
Days to Decision 32 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
56d faster than avg
Panel avg: 88d · This submission: 32d
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 75
Devices cleared under the same product code (CEO) and FDA review panel - the closest regulatory comparables to K823580.
PHOPHORUS REAGNET SET
K841061 · Medical Specialties, Inc. · May 1984
PHOSPHORUS REAGENT SYSTEM
K840215 · Sclavo, Inc. · Mar 1984
PARAMAX PHOSPHORUS REAGENT
K833002 · American Dade · Oct 1983
PSI INORGANIC PHOSPHORUS
K822470 · Pointe Scientific, Inc., · Sep 1982
KING DIAGNOSTICS PHOSPHORUS TEST
K811749 · King Diagnostics, Inc. · Jul 1981
ELVI INORGANIC PHOSPHOROUS
K792401 · Volu Sol Medical Industries · Dec 1979