Cleared Traditional

K881054 - CALCIUM

K881054 is the FDA 510(k) clearance for CALCIUM by Diagnostic Chemicals, Ltd. (Usa). It is a Class 2 Chemistry device (product code CIC) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K881054 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
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Apr 1988
Decision
38d
Days
Class 2
Risk

K881054 is an FDA 510(k) clearance for the CALCIUM, CATALOGUE NUMBER 122-20. Classified as Cresolphthalein Complexone, Calcium (product code CIC), Class II - Special Controls.

Submitted by Diagnostic Chemicals, Ltd. (Usa) (Charlottestown,Pei,Canada, CA). The FDA issued a Cleared decision on April 18, 1988 after a review of 38 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 Diagnostic Chemicals, Ltd. (Usa) devices

Submission Details

510(k) Number K881054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1988
Decision Date April 18, 1988
Days to Decision 38 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
50d faster than avg
Panel avg: 88d · This submission: 38d
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 K881054.
TECHNICON ASSIST(R) CALCIUM METHOD
K884433 · Technicon Instruments Corp. · Nov 1988
BIOTROL BILIRUBIN MONOREACTIF
K884480 · Biotrol, USA, Inc. · Nov 1988
CALCIUM
K880308 · Catachem, Inc. · May 1988
CALCIUM ASSAY KIT, NUMBER 120-19
K874496 · Diagnostic Chemicals, Ltd. (Usa) · Feb 1988
PARAMAX CALCIUM REAGENT
K873519 · Baxter Healthcare Corp · Dec 1987
CRESOLPHTHALEIN COMPLEXONE, CALCIUM
K874131 · Pointe Scientific, Inc., · Dec 1987