Cleared Special

K052982 - ROCHE DIAGNOSTICS COBAS ELECSYS PROLACT...

K052982 is the FDA 510(k) clearance for ROCHE DIAGNOSTICS COBAS ELECSYS PROLACT... by Roche Diagnostics. It is a Class 2 Chemistry device (product code JIT) cleared through the Special 510(k) pathway after a 4-day FDA review.

K052982 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
4d
Days
Class 2
Risk

K052982 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on October 28, 2005 after a review of 4 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 devices

Submission Details

510(k) Number K052982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2005
Decision Date October 28, 2005
Days to Decision 4 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
84d faster than avg
Panel avg: 88d · This submission: 4d
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 159
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ISE COMPENSATOR
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K050231 · Roche Diagnostics Corp. · Jul 2005