Cleared Traditional

K874131 - CRESOLPHTHALEIN COMPLEXONE

K874131 is the FDA 510(k) clearance for CRESOLPHTHALEIN COMPLEXONE by Pointe Scientific, Inc.,. It is a Class 2 Chemistry device (product code CIC) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K874131 · Pointe Scientific, Inc., · Chemistry device
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Dec 1987
Decision
52d
Days
Class 2
Risk

K874131 is an FDA 510(k) clearance for the CRESOLPHTHALEIN COMPLEXONE, CALCIUM. Classified as Cresolphthalein Complexone, Calcium (product code CIC), Class II - Special Controls.

Submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on December 4, 1987 after a review of 52 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 Pointe Scientific, Inc., devices

Submission Details

510(k) Number K874131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1987
Decision Date December 04, 1987
Days to Decision 52 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
36d faster than avg
Panel avg: 88d · This submission: 52d
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 K874131.
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
WAKO(TM) AUTOKIT CALCIUM
K873334 · Wako Chemicals USA, Inc. · Oct 1987
CALCIUM REAGENT - CRESOLPHTHALEIN COMPLEXON METHOD
K870362 · Trace Scientific , Ltd. · Aug 1987
SYSTEM PACK FOR B.M.D/HITACHI 704 CHEM. ANA.(GABA)
K872306 · Boehringer Mannheim Corp. · Aug 1987