Cleared Traditional

K860044 - CALCIUM (CPC) REAGENT SET

K860044 is the FDA 510(k) clearance for CALCIUM (CPC) REAGENT SET by Sterling Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CIC) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K860044 · Sterling Diagnostics, Inc. · Chemistry device
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Feb 1986
Decision
36d
Days
Class 2
Risk

K860044 is an FDA 510(k) clearance for the CALCIUM (CPC) REAGENT SET. Classified as Cresolphthalein Complexone, Calcium (product code CIC), Class II - Special Controls.

Submitted by Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on February 11, 1986 after a review of 36 days - a notably fast clearance cycle.

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: 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 Sterling Diagnostics, Inc. devices

Submission Details

510(k) Number K860044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1986
Decision Date February 11, 1986
Days to Decision 36 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
52d faster than avg
Panel avg: 88d · This submission: 36d
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 67
Devices cleared under the same product code (CIC) and FDA review panel - the closest regulatory comparables to K860044.
CRESOLPHTHALEIN COMPLEXONE, CALCIUM
K860664 · Amresco, Inc. · Jun 1986
CALCIUM PROCEDURE
K861657 · Data Medical Associates, Inc. · May 1986
A-GENT LIQUID CALCIUM
K860425 · Abbott Laboratories · Apr 1986
CALCIUM LIQUID STABLE REAGENT SET
K855041 · Medical Analysis Systems, Inc. · Jan 1986
AMRESCO CALCIUM REAGENT SET
K852657 · American Research Products Co. · Jul 1985
CALCIUM
K850281 · Boehringer Mannheim Corp. · Feb 1985