Cleared Special

K032377 - ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID

K032377 is an FDA 510(k) clearance for ROCHE DIAGNOSTICS HITACHI BICARBONATE L..., manufactured by Roche Diagnostics Corp.. The device is a Class 2 Chemistry device with product code KHS cleared through the Special 510(k) pathway after a 20-day FDA review.

K032377 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
20d
Days
Class 2
Risk

K032377 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID. Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 21, 2003 after a review of 20 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K032377

510(k) Number K032377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2003
Decision Date August 21, 2003
Days to Decision 20 days
Submission Type Special
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
68d faster than avg
Panel avg: 88d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 85
Devices cleared under the same product code (KHS) and FDA review panel - the closest regulatory comparables to K032377.
DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE
K061238 · Dade Behring, Inc. · May 2006
CARBON DIOXIDE
K060295 · Abbott Laboratories · May 2006
MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12
K042362 · Diagnostic Chemicals , Ltd. · Dec 2004
COBAS INTEGRA CARBON DIOXIDE ASSAY
K031879 · Roche Diagnostics Corp. · Jul 2003
JAS CARBON DIOXIDE LIQUID REAGENT
K012332 · Jas Diagnostics, Inc. · Sep 2001
ANALYST PANELS + ANALYTICAL TEST ROTOR
K010864 · Hemagen Diagnostics, Inc. · May 2001
K032377 · ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID
Download PDF FDA Summary Roche Diagnostics Cor…