Cleared Traditional

K880868 - CARBON DIOXIDE ASSAY KIT (ENZYMATIC) 20...

K880868 is the FDA 510(k) clearance for CARBON DIOXIDE ASSAY KIT (ENZYMATIC) 20... by Diagnostic Chemicals, Ltd. (Usa). It is a Class 2 Chemistry device (product code KHS) cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K880868 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
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Nov 1988
Decision
245d
Days
Class 2
Risk

K880868 is an FDA 510(k) clearance for the CARBON DIOXIDE ASSAY KIT (ENZYMATIC) 201-18/202-18. Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Diagnostic Chemicals, Ltd. (Usa) (Monroe, US). The FDA issued a Cleared decision on November 1, 1988 after a review of 245 days - an extended review 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: 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 Diagnostic Chemicals, Ltd. (Usa) devices

Submission Details

510(k) Number K880868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1988
Decision Date November 01, 1988
Days to Decision 245 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
157d slower than avg
Panel avg: 88d · This submission: 245d
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 K880868.
BICARBONATE
K891991 · Boehringer Mannheim Corp. · Jun 1989
BICARBONATE TEST ITEM NUMBER: SR1006
K890305 · Em Diagnostic Systems, Inc. · Feb 1989
ABBOTT SPECTRUM(R) BICARBONATE REAGENT
K884821 · Abbott Laboratories · Dec 1988
DART CARBON DIOXIDE
K883055 · Coulter Electronics, Inc. · Aug 1988
ENZYMATIC CO2 REAGENT SET
K882497 · American Monitor Corp. · Aug 1988
BICARBONATE (CO2) REAGENT-2 VIAL
K881938 · Trace Scientific , Ltd. · Jun 1988