Cleared Traditional

K891061 - BIOTROL CALCIUM MONOREACTIF

K891061 is an FDA 510(k) clearance for BIOTROL CALCIUM MONOREACTIF, manufactured by Biotrol, USA, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K891061

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.

CJY Device Classification - Class 2, Special Controls

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 43
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