Cleared Traditional

K872108 - ABBOTT SPECTRUM BICARBONATE REAGENT KIT

K872108 is an FDA 510(k) clearance for ABBOTT SPECTRUM BICARBONATE REAGENT KIT, 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 16-day FDA review.

K872108 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1987
Decision
16d
Days
Class 2
Risk

K872108 is an FDA 510(k) clearance for the ABBOTT SPECTRUM BICARBONATE REAGENT KIT. 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 June 17, 1987 after a review of 16 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 - K872108

510(k) Number K872108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1987
Decision Date June 17, 1987
Days to Decision 16 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
72d faster than avg
Panel avg: 88d · This submission: 16d
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 K872108.
CO2 REAGENT
K880268 · Sigma Diagnostics, Inc. · Mar 1988
BIOTROL BICARBONATE (CO2) UV HP)
K874941 · Biotrol, USA, Inc. · Jan 1988
BICARBONATE
K874435 · Boehringer Mannheim Corp. · Nov 1987
BICARBONATE PROCEDURE
K870062 · Data Medical Associates, Inc. · Feb 1987
EASY-TEST CARBON DIOXIDE (CO2) ITEM #67649/95
K863544 · Em Diagnostic Systems, Inc. · Sep 1986
BICARBONATE PROCEDURE
K861673 · Data Medical Associates, Inc. · Jul 1986