Cleared Traditional

K921855 - BIOTROL BICARBONATE STANDARDS

K921855 is the FDA 510(k) clearance for BIOTROL BICARBONATE STANDARDS by Biotrol, USA, Inc.. It is a Class 2 Chemistry device (product code JIS) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K921855 · Biotrol, USA, Inc. · Chemistry device
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Aug 1992
Decision
108d
Days
Class 2
Risk

K921855 is an FDA 510(k) clearance for the BIOTROL BICARBONATE STANDARDS. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Biotrol, USA, Inc. (Exton, US). The FDA issued a Cleared decision on August 3, 1992 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 K921855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1992
Decision Date August 03, 1992
Days to Decision 108 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 88d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIS Calibrator, Primary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIS Calibrator, Primary

All 93
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K921855.
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K920809 · King Diagnostics, Inc. · Apr 1992
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K910721 · Biotrol, USA, Inc. · May 1991
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K905820 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1991