Cleared Traditional

K870368 - PHOSPHORUS REAGENT-DIRECT UV METHOD W/O...

K870368 is the FDA 510(k) clearance for PHOSPHORUS REAGENT-DIRECT UV METHOD W/O... by Trace Scientific , Ltd.. It is a Class 1 Chemistry device (product code CEO) cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K870368 · Trace Scientific , Ltd. · Chemistry device
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Aug 1987
Decision
203d
Days
Class 1
Risk

K870368 is an FDA 510(k) clearance for the PHOSPHORUS REAGENT-DIRECT UV METHOD W/O REDUCTION. Classified as Phosphomolybdate (colorimetric), Inorganic Phosphorus (product code CEO), Class I - General Controls.

Submitted by Trace Scientific , Ltd. (Clayton, Vic 3168, AU). The FDA issued a Cleared decision on August 19, 1987 after a review of 203 days - an extended review 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: 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 Trace Scientific , Ltd. devices

Submission Details

510(k) Number K870368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1987
Decision Date August 19, 1987
Days to Decision 203 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
115d slower than avg
Panel avg: 88d · This submission: 203d
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 K870368.
INORGANIC PHOSPHORUS
K874472 · Catachem, Inc. · Dec 1987
PARAMAX PHOSPHORUS REAGENT
K873454 · Baxter Healthcare Corp · Nov 1987
EASY-TEST PHOSPHORUS (PHOS) ITEM NO. 16687
K874153 · Em Diagnostic Systems, Inc. · Nov 1987
FLOW-PAC INORGANIC PHOSPHORUS REAGENTS
K871321 · American Research Products Co. · Apr 1987
RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT
K870776 · Reagents Applications, Inc. · Mar 1987
EMDS(TM) PHOSPHORUS (PHOS) TESTPACKS, #67678/95
K863718 · Em Diagnostic Systems, Inc. · Oct 1986