Cleared Traditional

K042767 - DATAPRO CLINICAL CHELISTRY ANALYZER

K042767 is an FDA 510(k) clearance for DATAPRO CLINICAL CHELISTRY ANALYZER, manufactured by Thermo Electron Corporation. The device is a Class 2 Chemistry device with product code CFR cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K042767 · Thermo Electron Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
204d
Days
Class 2
Risk

K042767 is an FDA 510(k) clearance for the DATAPRO CLINICAL CHELISTRY ANALYZER. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Thermo Electron Corporation (Louisville, US). The FDA issued a Cleared decision on April 27, 2005 after a review of 204 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Thermo Electron Corporation devices

FDA 510(k) Submission Details - K042767

510(k) Number K042767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2004
Decision Date April 27, 2005
Days to Decision 204 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 88d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFR Device Classification - Class 2, Special Controls

Product Code CFR Hexokinase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 - CFR Hexokinase, Glucose

All 135
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K042767.
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
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ADVIA IMS GLUCOSE ASSAY
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K031135 · Dade Behring, Inc. · Jun 2003
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K024281 · Wako Chemicals USA, Inc. · Feb 2003