Cleared Traditional

K864661 - UNIFAST CALCIUM TEST

K864661 is the FDA 510(k) clearance for UNIFAST CALCIUM TEST by Sclavo, Inc.. It is a Class 2 Chemistry device (product code CIC) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K864661 · Sclavo, Inc. · Chemistry device
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Feb 1987
Decision
68d
Days
Class 2
Risk

K864661 is an FDA 510(k) clearance for the UNIFAST CALCIUM TEST. Classified as Cresolphthalein Complexone, Calcium (product code CIC), Class II - Special Controls.

Submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on February 4, 1987 after a review of 68 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 Sclavo, Inc. devices

Submission Details

510(k) Number K864661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1986
Decision Date February 04, 1987
Days to Decision 68 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
20d faster than avg
Panel avg: 88d · This submission: 68d
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 K864661.
SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA)
K871811 · Boehringer Mannheim Corp. · May 1987
CALCIUM TEST
K870629 · Sclavo, Inc. · Apr 1987
EASY-TEST CALCIUM (CA), ITEM NO. 67528/93
K870170 · Em Diagnostic Systems, Inc. · Mar 1987
CRESOLPHTHALEIN COMPLEXONE, CALCIUM
K864741 · Tech-Co, Inc. · Jan 1987
VISION (TM) CALCIUM
K863670 · Abbott Laboratories · Nov 1986
CALCIUM PROCEDURE
K863256 · Data Medical Associates, Inc. · Sep 1986