Cleared Traditional

K921855 - BIOTROL BICARBONATE STANDARDS

K921855 is an FDA 510(k) clearance for BIOTROL BICARBONATE STANDARDS, manufactured by Biotrol, USA, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K921855

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.

JIS Device Classification - Class 2, Special Controls

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 112
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