Cleared Traditional

CRESOLPHTHALEIN COMPLEXONE, CALCIUM (K860664) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K860664 · Amresco, Inc. · Chemistry device
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Jun 1986
Decision
123d
Days
Class 2
Risk

K860664 is an FDA 510(k) clearance for the CRESOLPHTHALEIN COMPLEXONE, CALCIUM. Classified as Cresolphthalein Complexone, Calcium (product code CIC), Class II - Special Controls.

Submitted by Amresco, Inc. (Solon, US). The FDA issued a Cleared decision on June 27, 1986 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - 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 Amresco, Inc. devices

Submission Details

510(k) Number K860664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1986
Decision Date June 27, 1986
Days to Decision 123 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 88d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIC Cresolphthalein Complexone, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
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 - CIC Cresolphthalein Complexone, Calcium

All 21
Devices cleared under the same product code (CIC) and FDA review panel - the closest regulatory comparables to K860664.
VISION (TM) CALCIUM
K863670 · Abbott Laboratories · Nov 1986
EMDS(TM) CALCIUM TESTPACKS, #67687/95
K863003 · Em Diagnostic Systems, Inc. · Sep 1986
ANALYST ANALYTICAL TEST ROTORS
K862274 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1986
A-GENT LIQUID CALCIUM
K860425 · Abbott Laboratories · Apr 1986
CALCIUM
K850281 · Boehringer Mannheim Corp. · Feb 1985
SYSTEMATE CALCIUM 67214
K843152 · Em Diagnostic Systems, Inc. · Aug 1984