Cleared Traditional

K931362 - IL TEST CALCIUM

K931362 is the FDA 510(k) clearance for IL TEST CALCIUM by Instrumentation Laboratory CO. It is a Class 2 Chemistry device (product code CIC) cleared through the Traditional 510(k) pathway after a 321-day FDA review.

K931362 · Instrumentation Laboratory CO · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
321d
Days
Class 2
Risk

K931362 is an FDA 510(k) clearance for the IL TEST CALCIUM. Classified as Cresolphthalein Complexone, Calcium (product code CIC), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on February 1, 1994 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K931362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1993
Decision Date February 01, 1994
Days to Decision 321 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
233d slower than avg
Panel avg: 88d · This submission: 321d
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 55
Devices cleared under the same product code (CIC) and FDA review panel - the closest regulatory comparables to K931362.
RANDOX CALCIUM
K000375 · Randox Laboratories, Ltd. · Apr 2000
COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
K963292 · Roche Diagnostic Systems, Inc. · Oct 1996
CALCIUM REAGENT
K944258 · Olympus America, Inc. · Jan 1995
CALCIUM TEST ITEM NUMBER 65409
K932158 · Em Diagnostic Systems, Inc. · Sep 1993
OLYMPUS CALCIUM REAGENT
K924435 · Olympus Corp. · Oct 1992
MILES URINE CALCIUM METHOD
K923034 · Heraeus Kulzer, Inc. · Sep 1992