Cleared Special

K041812 - MODIFICATION TO ROCHE DIAGNOSTICS PRECI...

K041812 is the FDA 510(k) clearance for MODIFICATION TO ROCHE DIAGNOSTICS PRECI... by Roche Diagnostics Corp.. It is a Class 1 Chemistry device (product code JJY) cleared through the Special 510(k) pathway after a 21-day FDA review.

K041812 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
21d
Days
Class 1
Risk

K041812 is an FDA 510(k) clearance for the MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND P.... Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 27, 2004 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 K041812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2004
Decision Date July 27, 2004
Days to Decision 21 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
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJY Multi-analyte Controls, All Kinds (assayed)

All 318
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K041812.
LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5
K042324 · Bio-Rad · Oct 2004
ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05
K042335 · Bio-Rad Laboratories, Inc. · Sep 2004
MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
K042389 · Roche Diagnostics Corp. · Sep 2004
RANDOX IMMUNOASSAY CONTROL
K040379 · Randox Laboratories, Ltd. · Jun 2004
MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA
K041227 · Roche Diagnostics Corp. · May 2004
DOCUMENT SALICYLATE CAL VER
K041073 · Microgenics Corp. · May 2004