Cleared Traditional

K884821 - ABBOTT SPECTRUM BICARBONATE REAGENT

K884821 is an FDA 510(k) clearance for ABBOTT SPECTRUM BICARBONATE REAGENT, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code KHS cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K884821 · Abbott Laboratories · Chemistry device
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Dec 1988
Decision
40d
Days
Class 2
Risk

K884821 is an FDA 510(k) clearance for the ABBOTT SPECTRUM(R) BICARBONATE REAGENT. Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on December 27, 1988 after a review of 40 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K884821

510(k) Number K884821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1988
Decision Date December 27, 1988
Days to Decision 40 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
48d faster than avg
Panel avg: 88d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHS Device Classification - Class 2, Special Controls

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 K884821.
BICARBONATE TEST ITEM NUMBER: 65412
K894509 · Em Diagnostic Systems, Inc. · Sep 1989
BICARBONATE
K891991 · Boehringer Mannheim Corp. · Jun 1989
BICARBONATE TEST ITEM NUMBER: SR1006
K890305 · Em Diagnostic Systems, Inc. · Feb 1989
CARBON DIOXIDE ASSAY KIT (ENZYMATIC) 201-18/202-18
K880868 · Diagnostic Chemicals, Ltd. (Usa) · Nov 1988
DART CARBON DIOXIDE
K883055 · Coulter Electronics, Inc. · Aug 1988
ENZYMATIC CO2 REAGENT SET
K882497 · American Monitor Corp. · Aug 1988