Cleared Traditional

K861673 - BICARBONATE PROCEDURE

K861673 is the FDA 510(k) clearance for BICARBONATE PROCEDURE by Data Medical Associates, Inc.. It is a Class 2 Chemistry device (product code KHS) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K861673 · Data Medical Associates, Inc. · Chemistry device
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Jul 1986
Decision
62d
Days
Class 2
Risk

K861673 is an FDA 510(k) clearance for the BICARBONATE PROCEDURE. Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on July 1, 1986 after a review of 62 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 Data Medical Associates, Inc. devices

Submission Details

510(k) Number K861673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1986
Decision Date July 01, 1986
Days to Decision 62 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
26d faster than avg
Panel avg: 88d · This submission: 62d
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 K861673.
ABBOTT SPECTRUM BICARBONATE REAGENT KIT
K872108 · Abbott Laboratories · Jun 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
RAICHEM CO2 REAGENT
K854544 · Reagents Applications, Inc. · Dec 1985
DATA ZYME CO2 PROCEDURE
K850903 · Data Medical Associates, Inc. · Apr 1985
ROCHE REAGENTS REAGENT FOR CO2
K844987 · Roche Diagnostic Systems, Inc. · Jan 1985