Cleared Traditional

K951221 - TOTAL CO2

K951221 is the FDA 510(k) clearance for TOTAL CO2 by Randox Laboratories, Ltd.. It is a Class 2 Chemistry device (product code KHS) cleared through the Traditional 510(k) pathway after a 332-day FDA review.

K951221 · Randox Laboratories, Ltd. · Chemistry device
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Feb 1996
Decision
332d
Days
Class 2
Risk

K951221 is an FDA 510(k) clearance for the TOTAL CO2. Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Antrim, N. Ireland, IR). The FDA issued a Cleared decision on February 15, 1996 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1160 - 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. Elevated predicate reliance profile. 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 Randox Laboratories, Ltd. devices

Submission Details

510(k) Number K951221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1995
Decision Date February 15, 1996
Days to Decision 332 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
244d slower than avg
Panel avg: 88d · This submission: 332d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHS Enzymatic, Carbon-dioxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1160
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 - KHS Enzymatic, Carbon-dioxide

All 65
Devices cleared under the same product code (KHS) and FDA review panel - the closest regulatory comparables to K951221.
COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)
K980996 · Roche Diagnostic Systems, Inc. · Jun 1998
SYNERMED ENZYMATIC CO2 REAGENT KIT
K960793 · Synermed, Inc. · Mar 1996
SERUM BICARBONATE/CARBON DIOXIDE
K955302 · Data Medical Associates, Inc. · Feb 1996
CARBON DIOXIDE (C02)
K942735 · Teco Diagnostics · Mar 1995
BOEHRINGER MANNHEIM BICARBONATE ASSAY
K933461 · Boehringer Mannheim Corp. · Dec 1994
BICARBONATE
K931887 · Em Diagnostic Systems, Inc. · Aug 1993