Cleared Traditional

K860664 - CRESOLPHTHALEIN COMPLEXONE, CALCIUM

K860664 is an FDA 510(k) clearance for CRESOLPHTHALEIN COMPLEXONE, manufactured by Amresco, Inc.. The device is a Class 2 Chemistry device with product code CIC cleared through the Traditional 510(k) pathway after a 123-day FDA review.

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

FDA 510(k) Submission Details - K860664

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
Combination Product No
PCCP Authorized No
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.

CIC Device Classification - Class 2, Special Controls

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 89
Devices cleared under the same product code (CIC) and FDA review panel - the closest regulatory comparables to K860664.
CALCIUM PROCEDURE
K863256 · Data Medical Associates, Inc. · Sep 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
CALCIUM PROCEDURE
K861657 · Data Medical Associates, Inc. · May 1986
A-GENT LIQUID CALCIUM
K860425 · Abbott Laboratories · Apr 1986
CALCIUM (CPC) REAGENT SET
K860044 · Sterling Diagnostics, Inc. · Feb 1986