Cleared Traditional

K820241 - WAKO CALCIUM C TEST

K820241 is the FDA 510(k) clearance for WAKO CALCIUM C TEST by Wako Chemicals USA, Inc.. It is a Class 2 Chemistry device (product code CIC) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K820241 · Wako Chemicals USA, Inc. · Chemistry device
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Feb 1982
Decision
14d
Days
Class 2
Risk

K820241 is an FDA 510(k) clearance for the WAKO CALCIUM C TEST. Classified as Cresolphthalein Complexone, Calcium (product code CIC), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 12, 1982 after a review of 14 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 Wako Chemicals USA, Inc. devices

Submission Details

510(k) Number K820241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1982
Decision Date February 12, 1982
Days to Decision 14 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
74d faster than avg
Panel avg: 88d · This submission: 14d
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 K820241.
COBAS REAGENT FOR CALCIUM
K823577 · Hoffmann-La Roche, Inc. · Jan 1983
LIQUIZYME CALCIUM REAGENT SET
K823219 · American Research Products Co. · Dec 1982
PSI CALCIUM REAGENT
K822469 · Pointe Scientific, Inc., · Sep 1982
ASTRA-T CALCIUM REAGENT
K820090 · Hi Chem, Inc. · Jan 1982
GILCHEM CALCIUM REAGENT
K812110 · Gilford Diagnostics · Aug 1981
KING DIAGNOSTICS CALCIUM TEST
K811748 · King Diagnostics, Inc. · Jul 1981