Cleared Special

ROCHE DIAGNOSTICS ELECSYS AFP CALSET II (K043095) - FDA 510(k) Clearance

Class II Immunology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K043095 · Roche Diagnostics Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
14d
Days
Class 2
Risk

K043095 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS ELECSYS AFP 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 November 23, 2004 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1150 - the FDA immunology device 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 K043095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2004
Decision Date November 23, 2004
Days to Decision 14 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 104d · This submission: 14d
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 Immunology devices follow this clearance model.