Cleared Traditional

K870776 - RAICHEM(TM) PHOSPHORUS REAGENT

K870776 is the FDA 510(k) clearance for RAICHEM(TM) PHOSPHORUS REAGENT by Reagents Applications, Inc.. It is a Class 1 Chemistry device (product code CEO) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K870776 · Reagents Applications, Inc. · Chemistry device
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Mar 1987
Decision
15d
Days
Class 1
Risk

K870776 is an FDA 510(k) clearance for the RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT. Classified as Phosphomolybdate (colorimetric), Inorganic Phosphorus (product code CEO), Class I - General Controls.

Submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on March 13, 1987 after a review of 15 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 Reagents Applications, Inc. devices

Submission Details

510(k) Number K870776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1987
Decision Date March 13, 1987
Days to Decision 15 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
73d faster than avg
Panel avg: 88d · This submission: 15d
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 74
Devices cleared under the same product code (CEO) and FDA review panel - the closest regulatory comparables to K870776.
EASY-TEST PHOSPHORUS (PHOS) ITEM NO. 16687
K874153 · Em Diagnostic Systems, Inc. · Nov 1987
PHOSPHORUS REAGENT-DIRECT UV METHOD W/O REDUCTION
K870368 · Trace Scientific , Ltd. · Aug 1987
FLOW-PAC INORGANIC PHOSPHORUS REAGENTS
K871321 · American Research Products Co. · Apr 1987
EMDS(TM) PHOSPHORUS (PHOS) TESTPACKS, #67678/95
K863718 · Em Diagnostic Systems, Inc. · Oct 1986
ABBOTT SPECTRUM PHOSPHORUS REAGENT
K863088 · Abbott Laboratories · Sep 1986
INORGANIC PHOSPHORUS PROCEDURE
K863264 · Data Medical Associates, Inc. · Sep 1986