Cleared Traditional

K880268 - CO2 REAGENT

K880268 is the FDA 510(k) clearance for CO2 REAGENT by Sigma Diagnostics, Inc.. It is a Class 2 Chemistry device (product code KHS) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K880268 · Sigma Diagnostics, Inc. · Chemistry device
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Mar 1988
Decision
54d
Days
Class 2
Risk

K880268 is an FDA 510(k) clearance for the CO2 REAGENT. Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 15, 1988 after a review of 54 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K880268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1988
Decision Date March 15, 1988
Days to Decision 54 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
34d faster than avg
Panel avg: 88d · This submission: 54d
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 K880268.
BICARBONATE (CO2) REAGENT-2 VIAL
K881938 · Trace Scientific , Ltd. · Jun 1988
CARBON DIOXIDE ASSAY KIT(ENZY. SINGLE) 203-10
K880866 · Diagnostic Chemicals, Ltd. (Usa) · Apr 1988
ANALYTE CARBON DIOXIDE ASSAYED ON TECHNICON RA(TM)
K880609 · Technicon Instruments Corp. · Mar 1988
BIOTROL BICARBONATE (CO2) UV HP)
K874941 · Biotrol, USA, Inc. · Jan 1988
BICARBONATE
K874435 · Boehringer Mannheim Corp. · Nov 1987
ABBOTT SPECTRUM BICARBONATE REAGENT KIT
K872108 · Abbott Laboratories · Jun 1987