Cleared Traditional

BOEHRINGER MANNHEIM BICARBONATE ASSAY (K933461) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K933461 · Boehringer Mannheim Corp. · Chemistry device
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Dec 1994
Decision
507d
Days
Class 2
Risk

K933461 is an FDA 510(k) clearance for the BOEHRINGER MANNHEIM BICARBONATE ASSAY. Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on December 5, 1994 after a review of 507 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Boehringer Mannheim Corp. devices

Submission Details

510(k) Number K933461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1993
Decision Date December 05, 1994
Days to Decision 507 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
419d slower than avg
Panel avg: 88d · This submission: 507d
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 29
Devices cleared under the same product code (KHS) and FDA review panel - the closest regulatory comparables to K933461.
DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137
K010206 · Dade Behring, Inc. · Mar 2001
CO2
K981840 · Abbott Laboratories · Jun 1998
COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)
K980996 · Roche Diagnostic Systems, Inc. · Jun 1998
BICARBONATE
K931887 · Em Diagnostic Systems, Inc. · Aug 1993
BICARBONATE
K924711 · Em Diagnostic Systems, Inc. · Dec 1992
ABBOTT QUICKSTART BICARBONATE TEST CO2 ITEM# 5A22
K912806 · Em Diagnostic Systems, Inc. · Sep 1991