Cleared Traditional

K896812 - CARBON DIOXIDE REAGENT

K896812 is the FDA 510(k) clearance for CARBON DIOXIDE REAGENT by Pointe Scientific, Inc.,. It is a Class 2 Chemistry device (product code KHS) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K896812 · Pointe Scientific, Inc., · Chemistry device
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Feb 1990
Decision
81d
Days
Class 2
Risk

K896812 is an FDA 510(k) clearance for the CARBON DIOXIDE REAGENT. Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on February 23, 1990 after a review of 81 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 Pointe Scientific, Inc., devices

Submission Details

510(k) Number K896812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1989
Decision Date February 23, 1990
Days to Decision 81 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
7d faster than avg
Panel avg: 88d · This submission: 81d
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 K896812.
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (ECO2)
K903144 · Eastman Kodak Company · Sep 1990
BICARBONATE REAGENTS AMRESCO PRODUCT #4326020
K904007 · Amresco, Inc. · Sep 1990
COULTER CARBON DIOXIDE REAGENT
K902229 · Coulter Corp. · Jun 1990
CO2 REAGENT (340 NM)
K896258 · Sigma Chemical Co. · Feb 1990
CARBON DIOXIDE REAGENT
K896590 · Pointe Scientific, Inc., · Feb 1990
BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS
K895748 · Catachem, Inc. · Dec 1989