Cleared Traditional

K880308 - CALCIUM

K880308 is an FDA 510(k) clearance for CALCIUM, manufactured by Catachem, 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.

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

FDA 510(k) Submission Details - K880308

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.

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 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 REAGENT SET
K880845 · Tech-Neal Scientific, Inc. · Apr 1988
CALCIUM ASSAY KIT, NUMBER 120-19
K874496 · Diagnostic Chemicals, Ltd. (Usa) · Feb 1988