Cleared Traditional

K894407 - ABBOTT SPECTRUM CALCIUM REAGENT

K894407 is an FDA 510(k) clearance for ABBOTT SPECTRUM CALCIUM REAGENT, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code CIC cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K894407 · Abbott Laboratories · Chemistry device
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Sep 1989
Decision
70d
Days
Class 2
Risk

K894407 is an FDA 510(k) clearance for the ABBOTT SPECTRUM(R) CALCIUM REAGENT. Classified as Cresolphthalein Complexone, Calcium (product code CIC), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on September 25, 1989 after a review of 70 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K894407

510(k) Number K894407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1989
Decision Date September 25, 1989
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 88d · This submission: 70d
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 72
Devices cleared under the same product code (CIC) and FDA review panel - the closest regulatory comparables to K894407.
COBAS READY CALCIUM REAGENT
K896224 · Roche Diagnostic Systems, Inc. · Aug 1990
CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432
K902479 · Amresco, Inc. · Jul 1990
CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM)
K901226 · Technicon Instruments Corp. · Apr 1990
CALCIUM TEST ITEM NUMBER: 65409
K893778 · Em Diagnostic Systems, Inc. · Sep 1989
IQ CALCIUM
K891217 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1989
TECHNICON RA-100 SYSTEM CALCIUM METHOD
K884599 · Technicon Instruments Corp. · Jan 1989