Cleared Special

K042490 - ELECSYS FOLATE II CALSET II

K042490 is the FDA 510(k) clearance for ELECSYS FOLATE II CALSET II by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code JIT) cleared through the Special 510(k) pathway after a 16-day FDA review.

K042490 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
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Sep 2004
Decision
16d
Days
Class 2
Risk

K042490 is an FDA 510(k) clearance for the ELECSYS FOLATE II CALSET II. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 30, 2004 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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.

View all Roche Diagnostics Corp. devices

Submission Details

510(k) Number K042490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2004
Decision Date September 30, 2004
Days to Decision 16 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
72d faster than avg
Panel avg: 88d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JIT Calibrator, Secondary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIT Calibrator, Secondary

All 137
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K042490.
ROCHE DIAGNOSTICS ELECSYS AFP CALSET II
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K040226 · Wako Chemicals USA, Inc. · Mar 2004