Cleared Traditional

K891061 - BIOTROL CALCIUM MONOREACTIF

K891061 is the FDA 510(k) clearance for BIOTROL CALCIUM MONOREACTIF by Biotrol, USA, Inc.. It is a Class 2 Chemistry device (product code CJY) cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K891061 · Biotrol, USA, Inc. · Chemistry device
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Aug 1989
Decision
162d
Days
Class 2
Risk

K891061 is an FDA 510(k) clearance for the BIOTROL CALCIUM MONOREACTIF. Classified as Azo Dye, Calcium (product code CJY), Class II - Special Controls.

Submitted by Biotrol, USA, Inc. (Westchester, US). The FDA issued a Cleared decision on August 10, 1989 after a review of 162 days - an extended review 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: 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 Biotrol, USA, Inc. devices

Submission Details

510(k) Number K891061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1989
Decision Date August 10, 1989
Days to Decision 162 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 slower than avg
Panel avg: 88d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CJY Azo Dye, 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 - CJY Azo Dye, Calcium

All 33
Devices cleared under the same product code (CJY) and FDA review panel - the closest regulatory comparables to K891061.
CALCIUM, CATALOGUE NUMBER140-20
K895873 · Diagnostic Chemicals, Ltd. (Usa) · Dec 1989
CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION
K894476 · Catachem, Inc. · Oct 1989
CALCIUM (ARSENAZO III) REAGENT
K894204 · Sigma Diagnostics, Inc. · Oct 1989
HI CHEM CALCIUM REAGENT #88808
K890584 · Hichem Diagnostics · Apr 1989
CALCIUM PLUS PROCEDURE
K890302 · Data Medical Associates, Inc. · Feb 1989
ROCHE REAGENT FOR CALCIUM
K883453 · Roche Diagnostic Systems, Inc. · Oct 1988