Cleared Traditional

K880308 - CALCIUM

K880308 is the FDA 510(k) clearance for CALCIUM by Catachem, Inc.. It is a Class 2 Chemistry device (product code CIC) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K880308 · Catachem, Inc. · Chemistry device
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May 1988
Decision
123d
Days
Class 2
Risk

K880308 is an FDA 510(k) clearance for the CALCIUM. Classified as Cresolphthalein Complexone, Calcium (product code CIC), Class II - Special Controls.

Submitted by Catachem, Inc. (Port Chester, US). The FDA issued a Cleared decision on May 27, 1988 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 Catachem, Inc. devices

Submission Details

510(k) Number K880308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1988
Decision Date May 27, 1988
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.

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 K880308.
CALCIUM TEST ITEM NUMBER: SR1009
K884986 · Em Diagnostic Systems, Inc. · Jan 1989
TECHNICON ASSIST(R) CALCIUM METHOD
K884433 · Technicon Instruments Corp. · Nov 1988
BIOTROL BILIRUBIN MONOREACTIF
K884480 · Biotrol, USA, Inc. · Nov 1988
CALCIUM, CATALOGUE NUMBER 122-20
K881054 · Diagnostic Chemicals, Ltd. (Usa) · Apr 1988
CALCIUM ASSAY KIT, NUMBER 120-19
K874496 · Diagnostic Chemicals, Ltd. (Usa) · Feb 1988
PARAMAX CALCIUM REAGENT
K873519 · Baxter Healthcare Corp · Dec 1987