Cleared Traditional

CALCIUM ASSAY KIT, NUMBER 120-19 (K874496) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K874496 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
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Feb 1988
Decision
101d
Days
Class 2
Risk

K874496 is an FDA 510(k) clearance for the CALCIUM ASSAY KIT, NUMBER 120-19. 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 February 11, 1988 after a review of 101 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 Diagnostic Chemicals, Ltd. (Usa) devices

Submission Details

510(k) Number K874496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1987
Decision Date February 11, 1988
Days to Decision 101 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 88d · This submission: 101d
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 98
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